News and Events
  • LEICA BIOSYSTEMS AND ADVANCED CELL DIAGNOSTICS PARTNER TO DEVELOP AND COMMERCIALIZE RNASCOPE-BASED DIAGNOSTIC AND COMPANION DIAGNOSTIC TESTS
    January 26, 2016

    NEWCASTLE UPON TYNE, UK & HAYWARD, CALIFORNIA, USA, January 26, 2016 – Leica Biosystems, a global leader in anatomical pathology solutions & workflow automation, and Advanced Cell Diagnostics, Inc. (ACD), a world leader in RNA biomarker analysis for precision medicine, today announced a comprehensive partnership to develop and commercialize tissue-based diagnostic tests based on ACD's RNAscope in situ hybridization (ISH) assays on Leica Biosystems' BOND clinical advanced staining instruments. The agreement supports Leica Biosystems' development and commercialization of fully automated RNAscope-based companion diagnostic (CDx) tests in partnership with biopharmaceutical companies.

    The combination of ACD's RNAscope technology with Leica Biosystems' fully automated pathology solutions allows the companies and laboratories in clinical markets to integrate the power of new RNA-based biomarker tests into the existing pathology workflow. These tests will be co-branded and commercialized exclusively by Leica Biosystems for use in clinical labs around the world.

    The market-leading RNAscope LS probes and reagents running on the Research Use Only BOND RX instrument will also be upgraded as ready-to-use kits with streamlined software, to make the system more robust and easy to use. The RNAscope LS products will continue to be branded and commercialized exclusively by ACD. The availability of RNAscope technology on both research and clinical advanced staining platforms provides a seamless path for diagnostic test developers to translate their research to the clinic.

    "We're very excited about the deepening partnership with Leica Biosystems. The adoption of RNAscope technology onto Leica Biosystems' clinical advanced staining instruments creates a new paradigm for tissue-based diagnostics." said Dr. Yuling Luo, President and CEO of ACD. "For the first time, diagnostic test developers in biopharmaceutical companies and pathology laboratories will be able to develop and commercialize novel tissue diagnostics with unprecedented ease, speed and performance."

    Colin White, VP advanced staining, at Leica Biosystems added: “Leica Biosystems is excited to expand the successful partnership with ACD in order to better serve our customers, many of whom are already enthusiastic users of the RNAscope technology. This partnership will create a powerful platform for the delivery of novel cancer diagnostics in a fully automated workflow environment."

    ACD's RNAscope technology enables the visualization of target RNA molecule in any cell, transforming tissue-based biomarker analysis and providing breakthrough solutions for clinical diagnostics and precision medicine. The RNAscope LS assays jointly launched by ACD and Leica Biosystems in 2014 have been adopted rapidly by major biopharmaceutical companies and leading research institutions for use in preclinical and translational research and for patient selection in clinical trials. Building on this success and customers' demand for robust, automated RNAscope tests for late-stage clinical trials and regulatory approval, the two companies will expand their partnership into clinical diagnostics with commercialization expected in the first half of 2016.

    About Advanced Cell Diagnostics

    Advanced Cell Diagnostics, Inc. (ACD) is a world leader in RNA biomarker analysis for precision medicine, providing the most advanced RNA analysis solutions for cell and tissue based diagnostics in molecular pathology. Its proprietary award-winning RNAscope technology is capable of detecting and quantifying RNA biomarkers with single-molecule sensitivity and single-cell resolution in routine clinical specimens. The technology has been employed in hundreds of peer-reviewed publications by a rapidly growing customer base of thousands of active users, including all of the top global biopharmaceutical companies and world-leading academic institutions. ACD builds strategic alliances with its customers and partners to develop companion diagnostic tests for existing and emerging therapeutics. ACD also pursues internal programs to develop and commercialize proprietary cancer diagnostic tests.Learn more about ACD and RNAscope technology at www.acdbio.com.

    About Leica Biosystems

    Leica Biosystems is a global leader in workflow solutions and automation, striving to advance cancer diagnostics to improve patients’ lives. Leica Biosystems provides anatomical pathology laboratories and researchers a comprehensive product range for each step in the pathology process, from sample preparation and staining to imaging and reporting. Leica’s easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is represented in over 100 countries. It has manufacturing facilities in 7 countries, sales and service organizations in 19 countries, and an international network of dealers. The company is headquartered in Nussloch, Germany. Visit www.leicabiosystems.com for more information.

    Media Contact – ACD:
    Steve Chen, Ph.D., Chief Operating Officer
    +1 (510) 259-9802
    schen@acdbio.com

    Media Contact – Leica Biosystems:
    Kristin O'Neill, Global Brand Marketing Manager
    +1 847 821 3537
    LBS-GlobalMarketing@leicabiosystems.com

  • Advanced Cell Diagnostics Appoints Dr. Robert J. Monroe as Chief Medical Officer
    December 16, 2015

    Hayward, California – December 16, 2015 – Advanced Cell Diagnostics, Inc. (ACD), a world leader in RNA biomarker analysis for precision medicine, announces the appointment of Robert J. Monroe, M.D., Ph.D., to its executive leadership team as Chief Medical Officer. Board certified in anatomic pathology, clinical pathology, and cytopathology, Dr. Monroe has demonstrated a record of success providing medical leadership for companies in the clinical diagnostics industry. Most recently, he served as Medical Director and Vice President of Laboratory Operations for Veracyte (VCYT), a diagnostics company focused on molecular cytology, where he led the company’s CLIA laboratories, including oversight of the highly successful Afirma® Thyroid FNA Analysis and recent launch of the PerceptaTM Bronchial Genomic Classifer. Prior to Veracyte, Dr. Monroe served as Chief Medical Officer of BioImagene (acquired by Ventana, a member of the Roche Group, in 2010), a leading provider of imaging solutions for anatomic pathology and clinical diagnostics where he headed the company’s efforts to develop software applications for pathologists, including multiple FDA-cleared algorithms for immunohistochemistry analysis. Dr. Monroe was also Co-Founder and Chief Medical Officer of OncoMDx, a Palo Alto-based molecular diagnostics laboratory later acquired by CORE Diagnostics to support expansion of next generation diagnostics in India. “ACD and its RNAscope technology have already established a leadership position in translational research and increasingly become a major platform for the development of diagnostic and companion diagnostic tests. I’m very excited to build on this success and help the company enter the clinical market with novel applications intended to improve diagnosis and guide treatment,” said Dr. Monroe. “ACD’s vision is to bring the power of molecular diagnostics to pathologists,” said Dr. Yuling Luo, President and CEO of ACD. “Dr. Monroe’s unique experience at the intersection of biotechnology, clinical diagnostics, and anatomic pathology makes him an ideal person to lead ACD’s efforts to develop high value clinical diagnostics,” Dr. Luo continued. About Advanced Cell Diagnostics Advanced Cell Diagnostics, Inc. (ACD) is a world leader in RNA biomarker analysis for precision medicine, providing the world's most advanced RNA analysis solutions for cell and tissue based diagnostics in molecular pathology. Its proprietary award-winning RNAscope® technology is capable of detecting and quantifying RNA biomarkers with single-molecule sensitivity and single-cell resolution in routine clinical specimens. The technology has been employed in hundreds of peer-reviewed publications by a rapidly growing customer base of thousands of active users, including all of the global top pharmaceutical companies, many cutting-edge biotechnology companies, and world-leading academic institutions. ACD builds strategic alliances with its customers and partners to develop companion diagnostic tests for existing and emerging therapeutics. ACD also pursues internal programs to develop and commercialize proprietary cancer diagnostic tests. Learn more about ACD and RNAscope technology at www.acdbio.com.

  • ACD Releases New Generation of RNAscope® Products for RNA Biomarker Analysis in FFPE Tissue
    October 21, 2015

    ACD Releases New Generation of RNAscope® Products for RNA Biomarker Analysis in FFPE Tissue

    Enhanced assay robustness heralds a new era for tissue-based RNA biomarker development

    HAYWARD, CALIFORNIA, October 21, 2015: Advanced Cell Diagnostics Inc. (ACD), the market leader in tissue-based RNA analysis tools for molecular pathology, has announced the release of its next version RNAscope® in situ hybridization (ISH) assay – RNAscope® 2.5.

    The current RNAscope® 2.0 assay has been gaining recognition rapidly in the research community, as indicated by its use in over 300 peer-reviewed publications within 4 years. More than ever, the translation of genomic discoveries to clinical applications demands high performance, ease of use and broad accessibility. Building on the groundbreaking advances introduced in RNAscope® 2.0, the 2.5 assay incorporates many refinements and enhancements to enable rapid, accurate assessment of tissue-based biomarker expression across the full spectrum of clinical formalin-fixed paraffin-embedded (FFPE) tissue samples at unprecedented levels of consistency and reproducibility without the need for lengthy rounds of assay optimization.

    Excellent results have already been achieved with RNAscope® 2.5 in an early access program, as Victoria Rimkunas, Head of the Integrated Diagnostics Lab at Merrimack Pharmaceuticals, Inc., summarized: “We are using RNAscope® technology in the development of our companion diagnostics assay pipeline. We participated in ACD’s early access program to evaluate RNAscope® 2.5 on Leica Biosystems’ BOND Rx system, and are very pleased with the results. We obtained strong sensitive detection with punctate dots and clean to no background, enabling easy identification of true signal without interference. We evaluated assay robustness across multiple tissue types and observed reproducibility across sites. We are happy to move forward with RNAscope® 2.5 and plan to use this assay and technology in future clinical studies.” 

    Dr. Yuling Luo, Founder, President and CEO of ACD, added: “I believe RNAscope® 2.5 ushers in a new exciting era for scientists seeking to develop tissue-based biomarkers, especially for companion diagnostics. The many refinements and innovations we’ve made in 2.5 add up to make a major difference in terms of robustness and reproducibility. It is now a diagnostic grade product. Our customers working on the cutting edge of translational research and companion diagnostic development now have a seamless path to the clinic – they can use the same platform for both research and diagnostics with no translation needed. We are very excited about that.”

    For further information, please visit rna.acdbio.com/rnascope2.5, or visit the website at www.acdbio.com.

    About Advanced Cell Diagnostics
    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the field of molecular pathology, developing cell and tissue‐based diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first automated multiplex chromogenic and fluorescent in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single‐molecule sensitivity. RNAscope® assays are currently used by thousands of customers, including all of the global top 10 pharmaceutical companies, world leading academic institutions and many cutting edge biotechnology companies to validate biomarkers for the management of cancer and other diseases.  ACD’s industrial partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop and commercialize proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope® technology at www.acdbio.com.

  • Advanced Cell Diagnostics Launches New Website and Online Store
    October 12, 2015

    Advanced Cell Diagnostics Launches New Website and Online Store
    Better serving the scientific community, the new site is equipped with a fresh design and interactivity, and features e-commerce capabilities 

    HAYWARD, CALIFORNIA, October 12, 2015: Advanced Cell Diagnostics Inc. (ACD), a technology and market leader in the field of molecular pathology and developer of cell and tissue-based RNA analysis tools, has announced the launch of its new website, www.acdbio.com. In response to the growing popularity of ACD’s proprietary RNAscope® in situ hybridization (ISH) technology, the site has been completely re-designed to better serve its thousands of monthly visitors. The new site graphically presents RNAscope technology, with streamlined navigation to interactively present all resources. New visitors can now rapidly and visually learn about the technology, see its applications and access relevant peer-reviewed publications. With fast and convenient e-commerce capabilities, ACD’s customers will also be able to access sales quotes in real time and place online orders, significantly easing the buying process. 

    In light of its ability to sensitively and specifically detect and quantify RNA targets in the context of the cell or tissue, RNAscope ISH is becoming an increasingly popular technology, with over 300 peer-reviewed publications to date featuring RNAscope ISH – currently at the rate of over 17 new publications per month. The new website reflects this business growth, together with the company’s continual dedication to customer service. Tom Olenic, Chief Commercial Officer of ACD, commented: “Of our monthly web visits, the majority are from scientists who are new to our technology, searching for how RNA ISH can enrich their research, so we prioritized visual presentation of our technology and diverse application content. On the other side, the sharp growth of our install base requires that we adopt modern B2B infrastructure to scale and ease the transactional processes. Scientists are busy; so searching through our 7,000 gene probe catalog, which grew by over 150% this past year, and selecting just the right probe for the right gene has to be fast and easy.” 

    ACD will continue to expand its online store features, soon to support customers outside of the US and also those who place orders using purchase orders. The new website is one facet of ACD’s initiative to incorporate modern business infrastructure to support and intimately interact with its growing customer base.

    For more information, you can see the new website at www.acdbio.com.

    About Advanced Cell Diagnostics
    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the field of molecular pathology, developing cell and tissue‐based diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first automated multiplex chromogenic and fluorescent in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single‐molecule sensitivity. RNAscope assays are currently used by thousands of customers, including all of the global top 10 pharmaceutical companies, world leading academic institutions and many cutting edge biotechnology companies to validate biomarkers for the management of cancer and other diseases.  ACD’s industrial partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop and commercialize proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope technology at www.acdbio.com.

  • ACD’s RNAscope® Technology Achieves 300-publication Milestone
    October 6, 2015

    ACD’s RNAscope® Technology Achieves 300-publication Milestone

    Use of next generation RNA In Situ Hybridization across a diverse array of applications

    HAYWARD, CALIFORNIA, October 6, 2015: Advanced Cell Diagnostics Inc. (ACD), a technology and market leader in the field of molecular pathology and developer of cell and tissue-based RNA analysis tools, is celebrating a significant milestone. Over 300 peer-reviewed research papers have now been published that feature ACD’s RNAscope technology as a core part of the research methodology, reflecting its facility in advancing the latest biological research in both academia and industry.

    RNA in situ hybridization (ISH) is a valuable tool for studying spatial and cell-specific gene expression, while preserving tissue architecture. ACD’s RNAscope represents a breakthrough advance in RNA ISH, implementing a proprietary signal amplification system to enhance both sensitivity and specificity, producing a high-performance assay that is also quick and easy to use. As awareness has spread of how RNAscope ISH can accelerate a variety of studies, its rise in uptake has translated to a rapid increase in published research. Thus far in 2015, the number of new publications has already exceeded 150, more than the total number of publications from all the previous years combined, signaling acceleration in technology adoption.

    Media Release

    Chief Scientific Officer, Dr. Xiao-Jun Ma, commented: “This rapid increase in publications speaks directly to the value of RNAscope technology in many fields of research. Spatially mapped single-cell gene expression data are crucial to understanding the development, structure and function of complex tissues at the molecular and cellular level. However, obtaining such data has been a huge bottleneck due to technical difficulties of traditional RNA ISH methods and the loss of contextual information with grind-and-bind assays. With RNAscope, such data can be generated within weeks from a concept to publication quality images.”

    The papers range from basic research in developmental biology, neuroscience, stem cells and ophthalmology, to translational research and diagnostic development of biomarkers in cancer and infectious diseases, in respected journals such as Nature, Science, Cell, New England Journal of Medicine, PNAS, PLoS One, and Clinical Cancer Research. 

    Browse ACD’s publication database online. For further information, you can also visit www.acdbio.com.

     

    About Advanced Cell Diagnostics

    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the field of molecular pathology, developing cell and tissue‐based diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first automated multiplex chromogenic and fluorescent in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single‐molecule sensitivity. RNAscope assays are currently used by thousands of customers, including all of the global top 10 pharmaceutical companies, world leading academic institutions and many cutting edge biotechnology companies to validate biomarkers for the management of cancer and other diseases.  ACD’s industrial partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop and commercialize proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope technology at www.acdbio.com

  • Advanced Cell Diagnostics Completes $22 Million Series C Equity Financing
    June 18, 2015

     

     

    Proceeds Will Accelerate Commercialization and Launch of New Technology Platforms

    Hayward, CA – June 18, 2015 – Advanced Cell Diagnostics, Inc. (ACD), a world leader in the field of in situ nucleic acid detection for life science research and clinical diagnostics, announced today that it has raised $22 million in Series C equity financing, led by growth equity investor Summit Partners with participation from Kenson Ventures and existing investors, Morningside Ventures and New Leaf Venture Partners.

    Proceeds from the financing will be used to accelerate the entry into the research and clinical diagnostics markets and launch new innovative technology platforms based on ACD's proprietary RNAscope® technology. 

    “ACD is a clear marker leader in in situ RNA detection, as validated by their rapid growth in revenue and strong customer base. Summit is excited to work with the company to expand its innovative products into new market sectors across the globe and to establish its RNAscope technology as a major diagnostic platform for precision medicine,” said Harrison Miller, a Managing Director with Summit Partners, who will join ACD’s Board of Directors.

    “ACD has been on a successful trajectory since its founding. Its RNAscope technology is a game-changer and has become part of the next wave of the genomic revolution. We welcome Summit and other new investors to join the team as we move forward," said Dr. Gerald Chan, Co-Founder of Morningside Ventures.

    “We are grateful for the enthusiastic responses from investors in our Series C financing round. It is a strong recognition of the potential of ACD's technology, which has already been featured in over 240 peer reviewed publications. The new funding will accelerate our pace of continued innovation and allow us to aggressively pursue our vision to bring RNAscope technologies to the forefront of precision medicine,” said Dr. Yuling Luo, Founder, President and CEO of ACD, “The company is now well-capitalized to realize this vision.”

    About RNAscope
    ACD's RNAscope represents a major technological advance in in situ RNA detection. This patented, groundbreaking platform is the first to enable robust single RNA molecule detection in routine formalin-fixed, paraffin-embedded (FFPE) clinical specimens. RNAscope provides rich molecular and morphological information in a single assay to maximize the clinical utility of RNA biomarkers. This is especially true in cancer diagnostics due to the significant intra-tumor heterogeneity and the complex involvement of the tumor microenvironment in tumor growth and therapeutic response. Since its commercialization over four years ago, RNAscope has seen rapid adoption across the globe by all major pharma/biotech companies and leading academic institutions for drug target validation, translational research, and the development of clinical diagnostics and companion diagnostic tests.  

    About Advanced Cell Diagnostics
    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the field of molecular pathology, developing cell and tissue based diagnostic tests for precision medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first automated multiplex chromogenic and fluorescent in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single molecule sensitivity. RNAscope assays are currently used by all of the global top 10 pharmaceutical companies, world leading academic institutions and many cutting edge biotechnology companies to validate biomarkers for the management of cancer and other diseases.  ACD’s industrial partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop and commercialize proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope technology at www.acdbio.com.

    About Summit Partners
    Summit Partners provides growth equity to exceptional entrepreneurs and management teams. Founded in 1984, the firm has raised more than $16 billion in capital and provides equity and fixed income for growth, recapitalizations and management buyouts. Summit has invested in more than 400 companies in healthcare and life sciences, technology and other growth sectors. These companies have completed more than 135 public offerings, and more than 150 have been acquired through strategic mergers and sales. Notable life science companies backed by Summit Partners include Clontech, Diagnostic Hybrids, Integrated DNA Technologies (IDT) and Fermentas International. Summit maintains offices in North America and Europe, and invests in companies around the world. For more information, visit www.summitpartners.com or follow on Twitter at @SummitPartners.

    In the United States of America, Summit Partners operates as an SEC-registered investment advisor. In the United Kingdom, this document is issued by Summit Partners Limited, a firm authorized and regulated by the Financial Conduct Authority. Summit Partners Limited is a limited company registered in England and Wales with company number 4141197, and its registered office is at 20–22 Bedford Row, London, WC1R 4JS, UK. This document is intended solely to provide information regarding Summit Partners’ potential financing capabilities for prospective portfolio companies.

    Media Contact –- ACD
    Steve Chen, Ph.D., Chief Operating Officer,
    schen@acdbio.com, +1 (510) 259-9802

  • Advanced Cell Diagnostics and Indica Labs Partner to Provide Quantitative RNA ISH Analysis Through ACD’s Pharma Assay Services
    June 17, 2015

    New Mexico, USA 06/15/2015 –Indica Labs, Inc. and Advanced Cell Diagnostics (ACD) announce the signing of a co-marketing partnership agreement to advance quantitative analysis in ACD’s RNAscope Pharma Assay Services.
    Under the terms of the agreement, ACD will utilize Indica Labs’ HALO™ image analysis software in its Pharma Assay Services (PAS) for high-throughput, precision interpretation of ACD’s RNAscope ISH assays for quantitative, single molecule in situ detection of RNA biomarkers. ACD will enhance the offerings of its PAS by employing HALO’s analytical capabilities in target validation and biomarker development studies involving single-target and multiplexed RNAscope. Additionally, ACD will utilize newly developed HALO algorithms for quantification of complex RNAscope expression data.

    Indica CEO Steven Hashagen remarked, “We are pleased to form this partnership with ACD. The RNAScope assay complemented by HALO image analysis represents the industry’s most comprehensive ISH quantification capabilities including multiplex chromogenic RNA ISH, multiplex RNA FISH, cell by cell expression profiles, and automated differentiation of discrete cell populations within tissue. These capabilities will enable ACD and their clients to unlock the full potential of RNA based biomarkers.”
    “ACD Chief Commercial Officer Tom O’Lenic stated, “ACD provides assays services to a wide range of biopharma with an expanding range of needs all relating to understanding target and biomarker expression in the context of disease pathology. This is a great fit between the multiplexed, molecular resolution of RNAscope and HALO, a multiplexed quantification software.” Mr. O’Lenic, went on to say, “Indica’s HALO will enable us to maximize the information value that we deliver in our services, as well as the speed with which we can deliver quantitative analysis to our PAS clients.”

    About Advanced Cell Diagnostics
    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the field of molecular pathology, enabling tissue-based, quantitative target and biomarker assays. The company’s products and services are based on its proprietary RNAscope® technology, the most sensitive and clinically robust automated RNA in situ hybridization platform capable of chromogenic, fluorescence and multiplexed detection and quantification of RNA biomarkers in situ with single molecule resolution. RNAscope is an established platform at all leading global pharmaceutical companies, world leading academic institutions and the majority of biotechnology companies for target validation, safety assessment and biomarker development in oncology and other major therapeutic areas. ACD’s Pharma Assay Services provide the context in which ACD supports preclinical and clinical therapeutic development. RNAscope is now being used for patient selection in late-stage clinical trials, which may be the basis for future companion diagnostic tests. ACD is also developing proprietary diagnostic tests for cancer management. Learn more about ACD and RNAscope technology at www.acdbio.com.

    About Indica Labs, Inc.
    Indica Labs is a leading provider software for quantitative evaluation of pathology images.  Indica’s HALO™ image analysis platform provides a unique combination of precision, performance, scalability, and usability. Indica’s broad range of industry leading tissue-specific image analysis algorithms can be used in a variety of truly integrated digital pathology environments, allowing pharmaceutical, healthcare, and research organizations worldwide to apply high-throughput image quantification in areas such as neuroscience, metabolism, oncology, toxicological pathology and more. For more information, please visit http://indicalab.com.

     

     

  • Flagship Biosciences Customizes Assay Development and Tissue Image Analysis for Advanced Cell Diagnostics RNAscope Platform
    April 16, 2015

    April 16, 2015, Westminster CO — Flagship Biosciences, the leading service provider of tissue image analysis solutions, announced today the utilization of its wet assay development and image analysis quantification capabilities for RNAscope® RNA in situ hybridization (ISH) from Advanced Cell Diagnostics, Inc. (ACD), a technology and market leader in the field of molecular pathology and developer of cell and tissue-based analysis tools. The two companies will work to optimize quantitative image analysis of in situ hybridization in tissue samples in Flagship’s CLIA laboratory.
     
    The increasing use of RNA ISH in companion diagnostics for drug development and CDx strategies require multidisciplinary expertise in pathology, assay development and image analysis in a CLIA laboratory environment. Flagship has leveraged ACD’s industry-leading in situ hybridization assay platform to support its clients ongoing CLIA based clinical trials to enable the utilization of RNAscope technology in CDx trials.
     
    “Flagship focusses on delivering unique fit-for-purpose quantitative pathology results, with advanced experience in both IHC and ISH assay development and custom image analysis. Over the last five years, our customers have benefited from our ability to focus our resources on unique scientific measurements using image analysis tools, which are able to overcome the obstacles barring clinical utility. By partnering with ACD, we are able to provide the state-of-the art in situ hybridization approaches, with quantitative endpoints suitable for a companion diagnostic strategy.” said Dr. Joseph Krueger, Chief Science Officer for Flagship Biosciences. 
     
    "One critical feature of the RNAscope assay is its ability to detect individual RNA molecules within the context of tissue morphology. This enables a quantitative expression readout at individual cell level, which opens the door to a higher level of precision biomarker analysis," said Dr. Xiao-Jun Ma, Chief Scientific Officer of ACD. "We are very pleased to work with Flagship to fully leverage this advantage, which is particularly important for the development of companion diagnostics."
     
     
    About Flagship Biosciences
     
    Flagship Biosciences, the industry leader in tissue image analysis, advances personalized medicine by quantifying and simplifying complex pathology. The company utilizes proprietary “fit for purpose” image analysis solutions to transform conventional, subjective methods of histopathology into clear actionable data to speed global drug development and approval. Further information on tissue-based companion diagnostics can be found at www.flagshipbio.com. 
     
    About Advanced Cell Diagnostics
     
    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the field of molecular pathology, developing cell and tissue based diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first automated multiplex chromogenic and fluorescent in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single molecule sensitivity. RNAscope assays are currently used by all of the global top 10 pharmaceutical companies, world leading academic institutions and many cutting edge biotechnology companies to validate biomarkers for the management of cancer and other diseases.  ACD’s industrial partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop and commercialize proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope technology at www.acdbio.com.

    Media Contact –- ACD
    Steve Chen, Ph.D., Chief Operating Officer,
    schen@acdbio.com, +1 (510) 259-9802

     

     

  • Advanced Cell Diagnostics' RNAscope Technology Supports Biomarker-Selected Phase 2 Clinical Trial of Merrimack Pharmaceuticals' MM-121
    March 9, 2015

    HAYWARD, CALIFORNIA, March 9, 2015: Advanced Cell Diagnostics, Inc. (ACD) announced today that Merrimack Pharmaceuticals, Inc. is using ACD's RNAscope technology to select patients for its Phase 2 clinical trial of its product candidate MM-121. Merrimack will utilize RNAscope to identify patients with heregulin positive, locally advanced or metastatic non-small cell lung cancer, making this Merrimack's first MM-121 trial to include only patients with a high heregulin biomarker profile. In previous MM-121 Phase 2 clinical trials, heregulin-positive patients, determined by RNAscope, have demonstrated significant therapeutic benefits when treated with a combination of MM-121 and standard therapies.

    “Our selection of the RNAscope-based heregulin test for this clinical trial is the culmination of multiple clinical studies in which we evaluated RNAscope. These trials have repeatedly demonstrated the potential of heregulin as a promising biomarker in predicting the therapeutic benefits of MM-121." stated Gavin MacBeath, Senior Vice President of Translational Research at Merrimack. "We believe that the high sensitivity and specificity that RNAscope provides are necessary to identify the patients most likely to benefit from MM-121in this Phase 2 clinical trial. RNAscope's ability to detect heregulin within the confines of tumor cells, compatibility with existing automation instruments and with small tissue specimens such as fine needle aspirates and core needle biopsies were all important considerations in our decision to work with ACD."

    "We are delighted that Merrimack has selected RNAscope as the biomarker platform for their MM-121 clinical program. This marks the first of many examples of RNAscope's adoption to support the development of companion diagnostic tools for pharma and biotech companies. We believe that RNAscope's robust capabilities and open platform make it an ideal foundation on which to develop highly capable CDx solutions that maximize trial efficiency by enabling drug developers to more effectively zero-in on those patients most likely to benefit." said Dr. Yuling Luo, Founder, President and CEO of ACD.

    For further information please visit www.acdbio.com.

    About RNAscope
    ACD's RNAscope represents a major technological advance in in situ RNA detection. This patented, breakthrough platform is the first to enable robust single RNA molecule detection in routine formalin-fixed, paraffin-embedded (FFPE) clinical specimens. RNAscope provides rich molecular and morphological information in a single assay to maximize the clinical utility of RNA biomarkers. This is especially true in cancer diagnostics due to the significant intra-tumor heterogeneity and the complex involvement of the tumor microenvironment in tumor growth and therapeutic response. Since its commercialization over three years ago, RNAscope has seen rapid adoption across the globe by all major pharma/biotech companies and leading academic institutions for drug target validation, translational research, and the development of clinical diagnostics and companion diagnostic tests. The RNAscope-based companion diagnostic test under development for Merrimack's MM-121 detects mRNA of heregulin, a ligand for the drug target of MM-121, ERBB3.

    About Advanced Cell Diagnostics
    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the field of molecular pathology, developing cell and tissue based diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first automated multiplex chromogenic and fluorescent in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single molecule sensitivity. RNAscope assays are currently used by all of the global top 10 pharmaceutical companies, world leading academic institutions and many cutting edge biotechnology companies to validate biomarkers for the management of cancer and other diseases.  ACD’s industrial partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop and commercialize proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope technology at www.acdbio.com.

    Media Contact –- ACD
    Steve Chen, Ph.D., Chief Operating Officer,
    schen@acdbio.com, +1 (510) 259-9802

  • Advanced Cell Diagnostics Appoints Tom Olenic as Chief Commercial Officer
    December 2, 2014

      HAYWARD, CALIFORNIA, December2, 2014:Advanced Cell Diagnostics, Inc. (ACD), a world leader in the field of in situ nucleic acid detection for life science research and clinical diagnostics, today announced the appointment of Tom Olenic to its executive leadership team as Chief Commercial Officer.

    Mr. Olenic has more than 25 years’ commercial and executive management experience in the biotechnology industry.Prior to joining ACD, Tom was General Manager of the Sequencing Organization and Senior VP of Commercial Operations of the Forensic Organization at IntegenX, Inc., where he implemented an aggressive global commercial strategy that achieved rapid revenue growth. He has also held commercial and senior management roles in companies ranging from startups to public corporations including Bios Corp., PerSeptive Bioscience, Millipore, Molecular Devices (a Danaher Company) and FreeSlate. At Molecular Devices, Tom held successful commercial leadership positions with increasing responsibilities, ending as the General Manager of an organization that grew from $10 million to over $200 million in annual revenue.

    “ACD and its RNAscope technology have already established a great reputation in life science research. I’m so excited to build on the early success and help scale up the commercialization to the next level.” said Mr. Olenic.

    “ACD's RNAscope has become indispensable for many researchers at the cutting edge to address the challenges of tumor heterogeneity and tumor microenvironment.” said Dr. Yuling Luo, Chief Executive Officer at ACD. “Tom has a proven track record of success in commercialization from early to major markets. He is a perfect fit for ACD to make RNAscope the assay of choice for the mainstream researchers and pathologists in this genomic era,” Dr. Luo continued.

    For further information, please visit www.acdbio.com.

    About Advanced Cell Diagnostics

    Advanced Cell Diagnostics, Inc. (ACD) is a leader in molecular pathology, developing cell and tissue‐based diagnostic tests for precision medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first multiplex chromogenic and fluorescent in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single‐molecule sensitivity. RNAscope assays are currently used by over a thousand customers, including all of the global top 10 pharmaceutical companies, world leading academic institutions and many cutting edge biotechnology companies to validate biomarkers for the management of cancer and other diseases.  ACD’s industrial partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop proprietary diagnostic tests in cancer management.

    Learn more about ACD and RNAscope technology at www.acdbio.com.

     

     

  • MicroMatrices Announces Partnership Agreement with Advanced Cell Diagnostics
    November 10, 2014

    MicroMatrices Announces Partnership Agreement with Advanced Cell Diagnostics

    MicroMatrices becomes preferred partner for preclinical use of ACD’s RNA ISH 

    DUNDEE, UK, November 10, 2014:
    MicroMatrices, a service provider specialised in high resolution cell type-specific analysis to characterise toxicological responses in different cell types in tissue, today announced a preferred partnership agreement with Advanced Cell Diagnostics, Inc. (ACD), a leader in the field of molecular pathology and developer of cell and tissue-based analysis tools.

    MicroMatrices solves molecular toxicological problems using unique visualization and localisation technologies, adding resolving power to standard methodologies. Consisting of a highly skilled core of scientists networked to facilities of excellence across the United Kingdom, MicroMatrices is scalable, efficient and flexible. MicroMatrices offers innovative, collaborative, state of the art solutions for unique efficacy and safety requirements.

    MicroMatrices has been well known for immunohistochemistry (IHC) staining and has recently become expert in the use of ACD’s RNAscope® Technology to detect RNA based biomarkers in situ. This has resulted in unique expertise in combined protein/RNA co-detection and co-localisation to offer clients an exceptional target visualisation capacity which can guide and/or corroborate mechanistic and mode of action studies. In recognition of MicroMatrices’ extensive experience in applying RNAscope in preclinical toxicology investigations for safety and efficacy, ACD has begun a preferred partnership program for the provision and/or development of preclinical applications of RNAscope Technology.

    Dr Simon Plummer, Managing Director of MicroMatrices commented; "The power and versatility of RNAscope has been an invaluable tool to enable us to solve mode of action/efficacy/toxicity challenges for our clients in the pharmaceutical, agrochemical, and chemical industries. We are delighted to be partnering with ACD to promote the wider application of RNAscope technology in preclinical safety/drug development problem solving for our collaborators".

    ACD's RNAscope assays represent a major technological advance for in situ RNA detection. For the first time, robust single RNA molecule detection is available for formalin-fixed, paraffin-embedded (FFPE) tissue offering quantitative molecular detection with morphological context in a single assay. Since their commercialisation three years ago, these assays have been adopted across the globe by major pharma biotech companies and leading research institutions for drug discovery, translational research, and the development of clinical and companion diagnostic tests.

    “ACD has established high quality performance standards through RNAscope products and services and MicroMatrices is known for quality, service and expertise in the drug development community," said Dr Steve Chen, Chief Operating Officer of ACD.  "As ACD's install base is growing very rapidly in Europe, they are an ideal partner not only to extend our reach but also to solidify our commitment in service quality.”

    Learn more about MicroMatrices and their services at www.micromatrices.com and about ACD and RNAscope technology atwww.acdbio.com.

    About MicroMatrices
    MicroMatrices solves molecular toxicological problems using unique visualisation/localisation technologies, adding resolving power to standard methodologies. Consisting of a highly skilled core of scientists networked to facilities of excellence across the UK, MicroMatrices is scalable, efficient and flexible. As leaders rather than followers, MicroMatrices offers innovative, collaborative, state of the art solutions for unique efficacy and safety requirements, throughout the life cycle of products.

    Founded in 2011, MicroMatrices is built upon Dr Simon Plummer’s 20 years of toxicological research at major international centres of excellence in the USA (NIH Bethesda), Australia (Peter MacCallum Cancer Institute, Melbourne) and the UK (MRC Toxicology Unit, Leicester) and is based in Dundee, a centre for world class life science research and innovation. Find out more atwww.micromatrices.com.

    About Advanced Cell Diagnostics
    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology, developing cell and tissue‐based diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first automated multiplex chromogenic and fluorescent in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single‐molecule sensitivity. RNAscope assays are currently used by hundreds of customers, including all of the global top 10 pharmaceutical companies, world leading academic institutions and many cutting edge biotechnology companies to validate biomarkers for the management of cancer and other diseases.  ACD’s industrial partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop and commercialize proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope technology atwww.acdbio.com.

  • Aquila-Histoplex Named First Certified European Service Provider by Advanced Cell Diagnostics
    November 4, 2014

    Aquila-Histoplex Named First Certified European Service Provider by Advanced Cell Diagnostics

    2014 November 04 | Posted by cmay@acdbio.com

     

    Aquila-Histoplex Named First Certified European Service Provider by Advanced Cell Diagnostics
    UK-Based Aquila-Histoplex to provide ACD’s industry-leading RNA ISH

    EDINBURGH, UK, November 4, 2014: Aquila-Histoplex, a contract research organisation specialised in histological and multiplex staining technologies, was today announced as the first accredited RNAscope® Certified Service Provider in Europe by Advanced Cell Diagnostics, Inc. (ACD), a technology and market leader in the field of molecular pathology and developer of cell and tissue-based analysis tools.

    Aquila-Histoplex focuses on multiplex molecular tissue probing using techniques such as immunohistochemistry, immunofluorescence or TUNEL and has over 2 years’ experience of performing the RNAscope assay for academic and commercial research sectors. “RNAscope is a perfect tool for completing our portfolio and we are delighted to be the first European service provider to be accredited by ACD” explained Mike Millar, CEO of Aquila-Histoplex. “As we provide commercial, clinical and academic research laboratories with bespoke, small to medium sized projects requiring specialist molecular multiplex staining and immunohistochemistry techniques – the addition of RNAscope as the market-leading RNA in situ hybridisation technology ensures that we can provide our clients with the highest quality RNA ISH data.”

    Advanced Cell Diagnostics’ RNAscope assays represent a major technological advance for in situ RNA detection. For the first time, robust single RNA molecule detection is available for formalin-fixed, paraffin-embedded (FFPE) tissue, offering quantitative molecular detection with morphological context in a single assay. Since their commercialisation three years ago, these assays have been adopted across the globe by major pharma biotech companies and leading research institutions for drug discovery, translational research, and the development of clinical and companion diagnostic tests.

    Advanced Cell Diagnostics’ Certified Service Provider Program is a collaborative service partnership dedicated to ensuring the delivery of the highest-quality RNA in situ hybridisation data available using the RNAscope Assay. “ACD's certification provides a competitive advantage for service providers and ensures that customers who use services from ACD's Certified Service Providers receive the industry-leading RNA ISH data quality and service they have come to expect from ACD. Aquila-Histoplex has demonstrated superior knowledge on performing the RNAscope assay and we are pleased to announce them as our first European Certified Service Provider” said Dr Steve Chen, Chief Operating Officer of ACD. 

    To find out more about Aquila-Histoplex’s services, please visit www.histoplex.co.uk and to learn more about ACD’s RNAscope technology, go to www.acdbio.com.

    About Aquila-Histoplex
    Aquila-Histoplex is a contract research organization delivering specialised histological, RNAscope and multiplex staining technologies to the both the academic and commercial biomedical research sectors. The company has a focus on multiplex molecular tissue probing using techniques such as:

    • Immunohistochemistry
    • Immunofluorescence
    • Multiplex staining
    • In-situ hybridisation
    • TUNEL
    • In-situ proximity ligation

    As well as routine paraffin and other sample preparation techniques and sections e.g. epoxy, methacrylate, alternative waxes, cryostat, freezing microtome, vibratome and ultra thin sectioning, Aquila-Histoplex also has access to a wide range of mainstream and advanced microscopic imaging platforms, image analysis software and expertise. Find out more about Aquila-Histoplex at www.histoplex.co.uk.

    About Advanced Cell Diagnostics
    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology, developing cell and tissue‐based diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first automated multiplex chromogenic and fluorescent in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single‐molecule sensitivity. RNAscope assays are currently used by hundreds of customers, including all of the global top 10 pharmaceutical companies, world leading academic institutions and many cutting edge biotechnology companies to validate biomarkers for the management of cancer and other diseases.  ACD’s industrial partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop and commercialize proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope technology atwww.acdbio.com.

     

     

  • Advanced Cell Diagnostics Awarded $1.4 Million NCI Grant to Develop Ultrasensitive Diagnostic Test
    October 6, 2014

    HAYWARD, CALIFORNIA, October 7, 2014:Advanced Cell Diagnostics, Inc. (ACD), a global technology and market leader in in situ nucleic acid detection for life science research and clinical diagnostics, has been awarded a two-year, $1.4 million grant from National Cancer Institute (NCI) under its SBIR Phase II Program. ACD and its academic partner Cleveland Clinic will use the grant to develop and validate a diagnostic test based on ACD’s proprietary RNAscope® technology for discriminating various B-cell non-Hodgkin lymphomas (NHLs) from benign lymphoproliferative diseases.

    “This award is a further validation of the clinical utility of RNAscope technology. We are very pleased that NCI has recognized the diagnostic potential of RNAscope technology and are grateful for its continued support”, commented by Dr Yuling Luo, President and CEO of ACD.

    Detection of B-cell clonality by demonstrating the restricted expression of one of the two immunoglobulin light chains (kappa or lambda) provides valuable molecular information for the diagnosis of NHLs. Formalin-fixed paraffin-embedded (FFPE) tissue is often the only sample type available for diagnostic testing in many clinical settings, however there has been a long-standing technical challenge in detecting light chain mRNAs in these tissues.

    “In Phase I, we developed a manual RNAscope-based assay for light chain mRNAs and demonstrated that it allowed determination of light chain restriction in virtually all types of NHL using FFPE with 99% concordance with the current gold standard assay flow cytometry using fresh tissue”, said Xiao-Jun Ma, Ph.D., ACD’s Chief Scientific Officer, and Principal Investigator.

    “This is an important advance in our ability to accurately diagnose B-cell lymphomas because conventional IHC (immunohistochemistry) and CISH (chromogenic in situ hybridization) methods to establish clonality simply don’t work for the majority of NHLs for various reasons”, said James Cook, M.D/Ph.D., hematopathologist and co-investigator at Cleveland Clinic.

    The Phase II grant will develop a fully automated assay and advanced image analysis algorithms for objective interpretation to facilitate clinical adoption.

    For further information, please visit www.acdbio.com.

    About Light Chain Restriction Detection

    Clonal expansion of B-lymphocytes harboring immunoglobulin (Ig) gene rearrangements is a hallmark of B-cell malignancy, and it is commonly manifested as restricted expression of one of the two Ig light chain mRNAs and proteins (kappa and lambda).Clinical laboratory detection of Ig light chain restriction (LCR) is a helpful ancillary tool in the differential diagnosis that includes lymphoid hyperplasia, atypical lymphoid hyperplasia, chronic inflammation, and B-cell neoplasia.

    LCR can be readily detected as an abnormal kappa/lambda surface immunoglobulin ratio by flow cytometry (FCM) using fresh tissue, the current gold standard for LCR detection. However, when only formalin-fixed, paraffin embedded (FFPE) tissue is available for evaluation, as is often the case in many clinical settings, immunohistochemistry (IHC) and conventional chromogenic in situ hybridization (CISH) are feasible only for B-cell neoplasms such as plasma cell myeloma that express abundant kappa or lambda mRNA and protein, leaving the majority of B-cell lymphomas without a sensitive method of LCR detection. RNAscope’s single-molecule sensitivity and single-cell resolution allow direct visualization kappa and lambda mRNAin FFPE tissue section under a standard bright-field microscope, thus addressing an unmet diagnostic need in B-cell lymphoma that has existed for over two decades.

    About Advanced Cell Diagnostics

    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology, developing cell and tissue‐based diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first automated multiplex chromogenic and fluorescent in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single‐molecule sensitivity. RNAscope assays are currently used by hundreds of customers, including all of the global top 10 pharmaceutical companies, world leading academic institutions and many cutting edge biotechnology companies to validate biomarkers for the management of cancer and other diseases.  ACD’s industrial partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop and commercialize proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope technology at www.acdbio.com.

  • ADVANCED CELL DIAGNOSTICS ESTABLISHES SUBSIDIARY TO SERVE THE EUROPEAN MARKET
    September 15, 2014

    ADVANCED CELL DIAGNOSTICS ESTABLISHES SUBSIDIARY TO SERVE THE EUROPEAN MARKET

    2014 September 15 | Posted by Quynh Doan

     

    Easy ordering, fast delivery and enhanced support for EU customers

     

    HAYWARD, CALIFORNIA, September 15, 2014:Advanced Cell Diagnostics Inc. (ACD), a technology and market leader in the field of molecular pathology and developer of cell and tissue-based analysis tools, has announced the establishment of a European subsidiary which will start business in October 2014.

    The move comes shortly after the company announced its probe library had grown to over 4000 probes andis indicative of the growing international demand for RNAscope® assays. The assays represent a major technological advance for in situ RNA detection, enabling robust single RNA molecule detection for the first time in formalin-fixed, paraffin-embedded (FFPE) tissue. Since their commercialisation three years ago, these assays have been adopted across the globe by major pharma biotech companies and leading research institutions for drug discovery, translational research, and the development of clinical and companion diagnostic tests.

    The news also highlights ACD’s continued commitment to providing exceptional customer service to its global customers; “ACD is very excited about the rapid expansion of our customer base in Europe," said ACD's Chief Operating Officer Steve Chen. "Establishing a local subsidiary is a natural next step for us to extend our market presence and provide a faster and enhanced level of service to our customers here.”

    The ACD European subsidiary has a warehousing and distribution centre located close to Milan, Italy, and sales, marketing and technical support staff in Germany and the UK. Such an arrangement offers significant benefits to European customers and eliminates troublesome and unpredictable import/export border issues. Product delivery becomes faster and more reliable with urgent orders of in-stock items able to be shipped next-day within Europe. In addition, customers will be able to place orders in Euros and technical and logistic support will be provided locally within the same time zone.

    For further information, please visit www.acdbio.com.

    About Advanced Cell Diagnostics

    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology, developing cell and tissue‐based diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first automated multiplex chromogenic and fluorescent in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single‐molecule sensitivity. RNAscope assays are currently used by hundreds of customers, including all of the global top 10 pharmaceutical companies, world leading academic institutions and many cutting edge biotechnology companies to validate biomarkers for the management of cancer and other diseases.  ACD’s industrial partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop and commercialize proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope technology at www.acdbio.com.

  • GENOMEWEB DAILY NEWS: ADVANCED CELL DIAGNOSTICS PREPS HPV ASSAY FOR LAUNCH, SEEKS ENTRY INTO CLINICAL DX MARKET
    September 12, 2014

    GENOMEWEB DAILY NEWS: ADVANCED CELL DIAGNOSTICS PREPS HPV ASSAY FOR LAUNCH, SEEKS ENTRY INTO CLINICAL DX MARKET

    2014 September 12 | Posted by Quynh Doan

     

    Click here to log in and read article directly on GenomeWeb

    ADVANCED CELL DIAGNOSTICS PREPS HPV ASSAY FOR LAUNCH, SEEKS ENTRY INTO CLINICAL DX MARKET
    September 12, 2014
    By Tony Fong

    NEW YORK (GenomeWeb) – After gaining traction in the research market, Advanced Cell Diagnostics is poised to bring its RNA detection technology to the clinical space.

    For the past three years, the Hayward, Calif.-based firm has made its technology called RNAscope available to the research-use only market. Based on the reception the technology has received and continued improvements to it, ACD now plans to plans to pursue CE marking then enter the clinical diagnostic space with a small-scale launch of an assay for human papillomavirus and head-and-neck cancer by the end of the year.

    Since launching RNAscope, ACD has signed on about 800 accounts in the pharmaceutical space, which has used RNAscope for new drug discovery purposes, and with academic/government researchers, who have used the technology for translational research, stem cell research, and infectious disease studies.

    In August, the company received ISO 13485:2003 certification, setting the table for its diagnostics ambitions. In addition to the HPV test, ACD is developing a test for B-cell lymphoma and proliferative diseases.

    In approaching the clinical diagnostic space, ACD is taking a three-pronged strategy, Co-founder and CEO Yuling Luo told GenomeWeb Daily News recently.First, the company is developing its own tests, such as the HPV and B-cell lymphoma assays. Secondly, ACD will partner with pharma and other companies to develop companion diagnostic tests. And lastly, it plans to license the RNAscope technology to customers who want to develop their own assays.

    For now, the company is focused on preparing for the launch of the HPV assay. RNAscope assays are designed to be platform-agnostic, and ACD has deals withRoche's Ventana and Danaher's Leica Biosystems to co-market its tests on their automated in situ hybridization platforms. However, the HPV assay will be initially made available in a manual format as that is the quickest way to market, Luo said.

    While others have tried to develop RNA-based diagnostics in the past, "no robust RNA ISH technology [has been available] until RNAscope came along," he told GWDN. "We have always set our sight on the diagnostic market, but there is a strong demand for our technology in the research market, as well. Like PCR, going into the research market first allowed [the] natural evolution of a novel technology."

    Having achieved that, "we are at the stage where the technology is ready to move into diagnostics," Luo said.

    Solving the heterogeneity puzzle

    Luo started developing the RNAscope technology while he was at Panomics, a company that he co-founded and which Affymetrix acquired in 2008. The work he did developing RNAscope was independent of Panomics, though it had access to the technology. As a result of its Panomics buy, Affy has a non-exclusive license to the early version of the technology, but not the current iteration of it.

    The goal in developing RNAscope was to create a technology that could address on the molecular level intra-tumor heterogeneity, an underlying factor in many instances of drug resistance in cancer patients and overall drug ineffectiveness, Luo explained.

    RNA in situ detection technology has been around for about 40 years, but its performance has been disappointing, Luo said, because development efforts have focused on amplifying the signal.

    "The fundamental problem is that the probe that [binds] to your target gene also has a propensity to bind with non-specific sequences because you have billions of bases out there," he said. "So when you amplify [your] signal, you basically also amplify the background."

    RNAscope seeks to solve this through the use of independent oligonucleotides, which are placed next to each other and bind to the same target sequence, resulting in the amplification of the signal but not the background.

    "As you can imagine, the chances of two independent oligos [binding] to a non-specific target and being next to each other … is close to zero," Luo said, adding this design results in practically no background noise.

    The oligos are generic, being 20 to 25 bases in length, but ACD has developed an algorithm that determines suitable sequences for the assay while ensuring that hybridization to non-target sequences don't occur. "They don't get into high [guanine-cytosine] content or low [guanine-cytosine] content," Luo said.

    Meanwhile, the other parts of the probe will bind to the signal amplifier.

    The technology works for any gene and species, and can be used on formalin-fixed, paraffin-embedded tissue, a tissue type routinely used in clinical applications. As it prepared to move RNAscope to clinical applications, ACD has been further developing and improving its performance for FFPE.

    ACD's clinical ambitions for the technology are driven by what Luo said are unmet needs. Specifically, while there are HPV tests already on the market, he said that most are for screening, while ACD is developing its assay to detect the two gold standard biomarkers, E6 and E7 mRNA, for transcriptionally active HPV.

    Unlike ACD's planned test, "[t]he HPV screening tests out there use cytology specimens and are not designed to diagnose a specific lesion," Luo said.

    In a study published earlier this year in PLoS One, Luo, along with collaborators from the University of Vermont and Fletcher Allen Healthcare were able to correlate the results of the RNAScope HPV chromogenic in situ hybridization assay with pathological diagnoses, in particular the assay's ability to distinguish cervical intraepithelial neoplasia (CIN) grade 2 and 3.

    CIN, the development of squamous cells on the cervix's surface which then may progress to cancer, is categorized into three groups — CIN 1 considered a mild stage of dysplasia and CIN 3 considered severe dysplasia to carcinoma in situ.

    Luo also noted that its HPV test would have use as a companion diagnostic. There are two distinct classes of patients in head-and-neck cancer with different prognoses, and clinical trials are currently being conducted by pharma to determine whether the different classes may need to be treated differently.

    Once ACD's test is launched as a prognostic assay, Luo said, the company anticipates it will also be used as a companion diagnostic test for clinical trials to determine the efficacy of different treatments. To that end, ACD currently is working with pharma firms, including each of the 12 largest drug makers, to explore RNAscope for this application as well as for biomarker validation and safety and toxicity testing.

    While companion diagnostic work has traditionally relied on immunohistochemistry and fluorescent in situ hybridization technologies, fundamental problems exist with each of those technologies. For example, with IHC, about 75 percent of human genes lack robust, validated antibodies, and of the remaining 25 percent, only 5 percent have antibodies that will result in the same staining patterns if they come from different sources, Luo said.

    "So there is a significant unmet need to come up with technology that can complement what IHC can do," he said, adding that for many genes, including secreted proteins such as growth factors, cytokines, and chemokines, "you are never going to have good antibodies."

    Further, pharma customers are also using RNAscope as a follow-up technology to next-generation sequencing, whereby the customers discover new biomarkers via NGS, then use ACD's technology to translate candidate genes for potential diagnostic purposes, he said.

    "That's why pharma is using our technology for companion diagnostics — because they see a clear path to IVD testing that can be much more easily adopted, Luo said.
    ACD is currently clinically validating its HPV test, and the company expects to first launch the test with key customers so it can gather feedback and better understand the assay's performance to make improvements, Luo said. A broader commercial launch of the assay is anticipated for 2015.
    ACD also plans to eventually launch the test in the US, which would require US Food and Drug Administration approval, he added, though he did not provide details about those plans.
     

    In the hopper

    Also in the company's pipeline is an assay for detecting B-cell lymphoma or proliferative disease, which is currently performed using IHC methods. Luo said IHC works only for "a small fraction" of lymphoma cases, typically for cancers that are derived from a plasma cell and where the expression level is "super high."
    In the majority of cases, though, the marker is expressed at too low a level for antibodies to work well, he added, estimating IHC-based tests are effective in about 20 to 30 percent of cases.

    RNAscope, because it can detect down to the single-molecule level, can detect "basically for any type of B-cell lymphoma case," Luo said. Another key differentiator of the assay is that FFPE can be used as the testing sample. By comparison, flow cytometry-based methods for detecting B-cell lymphoma require fresh tissue, which is not always available.

    "The ability to analyze all subtypes of B-cell lymphomas is important because most common subtypes express light chains at low levels that are below the limit of detection of conventional ISH and IHC," Luo said. "IHC performs poorly also because it frequently has a high background staining due to light chain proteins secreted from normal B cells."

    While Luo did not have a precise figure on revenues anticipated from ACD's entry into the clinical space, he suggested that it could be significant. Because ACD is privately held, he did not want specifics about ACD's finances to be made public, but told GWDNthat the firm has been growing "very fast already" and that once it moves into the diagnostics arena, that growth would further accelerate. "We will have a different growth trajectory," he said.

    Luo and Steve Chen, ACD's chief operating officer, founded the company together in 2006. In 2009, ACD raised $5.4 million in Series A financing led by Morningside Ventures. Three years later, a Series B round led by New Leaf Venture Partners raised $12 million. Additionally, the company has received about $5 million in total government funding.

    Luo said that ACD does not have plans to do any additional financing. "We actually have the funding to go all the way to profitability" and to launch the CE-marked HPV test, he said. However, he did not completely rule out a new financing round in the near- to mid-term in order to finance new technology development or to accelerate the commercialization process.

  • ADVANCED CELL DIAGNOSTICS AND LEICA BIOSYSTEMS BEGIN CO-MARKETING FULLY AUTOMATED RNA IN SITU HYBRIDIZATION ASSAY
    August 13, 2014

    ADVANCED CELL DIAGNOSTICS AND LEICA BIOSYSTEMS BEGIN CO-MARKETING FULLY AUTOMATED RNA IN SITU HYBRIDIZATION ASSAY

    2014 August 13 | Posted by Quynh Doan

     

    MELBOURNE, AUSTRALIA & HAYWARD, CALIFORNIA, August13, 2014–Leica Biosystems and Advanced Cell Diagnostics, Inc. (ACD) have announced the co-marketing of ACD's RNAscope® LS ISH assays with Leica Biosystems' BOND RX research staining platform*. This agreement provides researchers with an integrated and fully automated ISH solution. The market-leading RNAscope LS reagent kits and ISH probes are available from ACD while the BOND RX instrument and associated reagents are supplied by Leica Biosystems.

    ACD's RNAscope assays represent a major technological advance forin situ RNA detection. For the first time,robust single RNA molecule detection is available for formalin-fixed, paraffin-embedded (FFPE) tissue. Since their commercialization three years ago, these assays have been adopted across the globe by major pharma biotech companies and leading research institutions for drug discovery, translational research, and the development of clinical and companion diagnostic tests. The RNAscope LS assays are fully automated on the BOND RX platform. This open and flexible system automates staining to provide a fast, high throughput workflow with exceptional consistency and minimal hands-on time.

    "Automation is essential for pharmas, biotechs, translational labs and academic institutions to apply the RNA ISH technology to a wide range of biomarker analysis applications." said Dr. Yuling Luo, President and CEO of ACD. "We are very pleased to work with Leica Biosystems to expand our automated RNAscope solutions in response to the needs of our rapidly growing customer base."

    Dr.David Atkins, VP Advanced Staining at Leica Biosystems added: “Leica is excited to announce the availability of ACD's RNAscope Assays fully automated on the BOND RX. This is another example of how,with its openness and flexibility, the BOND RX is providing researchers with enhanced tools to help speed-up important discoveries and improve cancer diagnostics".

    *For Research Use Only. Not for use in diagnostic procedures.

    Learn more about ACD at www.acdbio.com and about RNAscope(R) Automated Solutions at acdbio.com/products/automated-assays

    Further information about Leica Biosytems can be found at www.LeicaBiosystems.com.

    Contact
    Media Contact –- ACD
    Steve Chen, Ph.D., Chief Operating Officer,
    schen@acdbio.com, +1 (510) 259-9802

  • ADVANCED CELL DIAGNOSTICS RECEIVES ISO 13485:2003 CERTIFICATION
    August 11, 2014

    ADVANCED CELL DIAGNOSTICS RECEIVES ISO 13485:2003 CERTIFICATION

    2014 August 11 | Posted by Quynh Doan

     

    RNAscope® Technology Poised for Development as a Diagnostic Platform

     HAYWARD, CA, USA (August 11 2014): Advanced Cell Diagnostics, Inc. (ACD), a global technology and market leader in in situ nucleic acid detection for life science research and clinical diagnostics, has been granted ISO 13485:2003 certification, an international quality standard for medical devices, paving a path for ACD to launch its CE marked diagnostic tests in Europe.

    The International Organization for Standardization (ISO) is the world's largest developer and publisher of international standards for the implementation of quality management systems and various other technical and operational procedures. ACD’s ISO 13485:2003 certification covers the design, development, production, and commercialization of ACD’s proprietary RNAscope® product lines. Addressing a long-standing technological gap in the analysis of RNA, RNAscope has seen rapid adoption by both academic and industrial researchers since the beginning of its full commercialization in 2011. There is strong interest in moving RNAscope-based biomarker assays from research to the clinic. 

    "ACD's vision is to make RNAscope the PCR equivalent for in situ nucleic acid detection and drive adoption of this technology in diagnostic tests," states Dr. Yuling Luo, President and CEO of ACD. "This ISO certification is the first step in our quality systems road map, which is designed to ensure that we supply products of the highest quality to our customers and provide a seamless path for our partners to translate scientific advances to patient benefits."

    ACD's RNAscope technology is the first automated multiplex RNA in situ hybridization platform capable of detecting and quantifying biomarkers with single‐molecule sensitivity. Unlike “grind‐and‐bind” assays such as RT‐PCR requiring RNA extraction from tissues, RNAscope detects and localizes single RNA molecules in individual cells in intact tissues, enabling simultaneous molecular and histopathological analysis. Unlike immunohistochemistry (IHC) which is often limited by lack of quality antibodies and inapplicable to the large emerging class of non‐coding RNAs, RNAscope assays can be developed and validated in two weeks for virtually any gene in any genome regardless of coding potential. RNAscope assays can be performed manually or fully automated using standard automated slide staining instruments for IHC and ISH, allowing seamless integration of RNAscope into current clinical laboratory workflows.

    About Advanced Cell Diagnostics

    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology, developing cell and tissue‐based diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first automated multiplex chromogenic and fluorescent in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single‐molecule sensitivity. RNAscope assays are currently used by hundreds of customers, including all of the global top 10 pharmaceutical companies, world leading academic institutions and many cutting edge biotechnology companies to validate biomarkers for the management of cancer and other diseases.  ACD’s industrial partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop and commercialize proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope technology at www.acdbio.com

  • ADVANCED CELL DIAGNOSTICS RNASCOPE® IN SITU HYBRIDIZATIONTECHNOLOGY GAINS SIGNIFICANT TRACTION
    July 15, 2014

    ADVANCED CELL DIAGNOSTICS RNASCOPE® IN SITU HYBRIDIZATIONTECHNOLOGY GAINS SIGNIFICANT TRACTION

    2014 July 15 | Posted by Quynh Doan

     

    Highly sensitive and easy-to-use technology validated in over 100 papers in three years; probe library exceeds 4000

    HAYWARD, CA, USA(July15 2014):Advanced Cell Diagnostics Inc. (ACD), a leader in the field of molecular pathology and developer of cell and tissue-based analysis tools, has announced that its RNAscope®RNAin situ hybridization technology has reached two major milestones.In just three years, over 100 peer-reviewed papers featuring the technology have been published, andwith the significant increase in use of RNAscope, ACD has nowbuilt a library of over 4000 target probes for numerous species. Probes are designed to order in under twoweeks, and in just six months the library has grown by over 1500, reflecting the wide interest in ACD’s breakthrough technology.

    RNAscope uniquely has the sensitivity to enable researchers to detect in situ single RNA molecules and provide quantitative analysis of gene expression at a single cell level. In addition, the technology provides morphological context by showing spatial and cell-specific expression while preserving tissue architecture. RNAscope’s ability to unlock the full potential of RNA biomarkers, together with its highly reproducible and easy-to-use technology, has resulted in an average of over 6 papers a month published so far in 2014 - a rate that is doubling every year. Now in wide use throughout academia and industry, the papers range from basic research in developmental biology, neuroscience and stem cells to clinical research such as cancer biomarkers, infectious diseases and ophthalmology, in respected journals such as Nature, Science, Cell, PLoS One, PNAS and Clinical Cancer Research.

    Localizing and quantifying RNA sequences in the context of cells and tissues is a fundamental approach in molecular biology. RNAscope makes it accessible to researchers of any level of experience, as Alexey Pronin, PhD of the University of Miami School of Medicine, who recently published in PLoS One, explained. “Even though I had no previous experience of in situ hybridization, the RNAscope assay was easy to perform and worked first time, allowing us to confirm the expression of three different genes in the mouse eye that we had previously identified via transcriptomics. Importantly, the multiplex assay showed that two of the genes are expressed in two separate cell layers of the eye blood vessels – information that would be hard to get using other technologies.”
    “Publications from our customers are particularly exciting, as it shows the growing validation and adoption of our technologies at the forefront of scientific research”,said Xiao-Jun Ma, ACD’s CSO. “And with our probe cataloggrowing by 240% in the last year, targeting more than 4,000 genes in many species, it’s a real testament to the demand for our technology, our fast probe development times and the scalability of our platform. Together, these two milestones are a comprehensivevalidation of the effectiveness of RNAscope technology. In this age of single-cell transcriptomics, RNA in situhybridization will prove to be indispensable in the effort to characterize the many newly discovered genes, especially the vast repertoire of noncoding RNA genes. We believe that the specific benefits of RNAscope technology will undoubtedly accelerate the translation of genomic discoveries to clinical medicine including new therapeutics and diagnostics."

    Image: Gli1 and APOE mRNA expression in mouse brain FFPE tissue using RNAscope® 2-plex Chromogenic Reagent Kit

    For more information about the published research on RNAscope, please visit www.acdbio.com/milestoneJuly2014

    About Advanced Cell Diagnostics, Inc. (ACD)

    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology, developing cell and tissue-based research tools for all areas of biomedical research, and diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the most sensitive method available for RNA in situ hybridization, and the first quantitative and fully automated platform enabling multiplex fluorescent and chromogenic RNA biomarker analysis. ACD partners with pharmaceutical and biotechnology companies to validate biomarkers for targeted therapeutic development in cancer and other diseases. These partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope® technology at www.acdbio.com.

  • European Webinar: RNAscope® - a novel breakthrough RNA in situ hybridization platform
    June 17, 2014

    European Webinar: RNAscope® - a novel breakthrough RNA in situ hybridization platform

    2014 June 17 | Posted by ACD

     

    European Webinar: RNAscope® - a novel breakthrough RNA in situ hybridization platform

    Thursday, June 26, 2014 4:00 PM - 4:30 PM CEST
     

    Abstract: 

    This webinar will introduce RNAscope® - a novel breakthrough RNA in situhybridization platform, designed and validated for visualizing RNA molecules with single copy sensitivity We will show you that RNAscope® offers:

    • Single RNA detection – there is no more sensitive in situ assay
    • 100-fold greater sensitivity than conventional dig-ISH
    • Greater sensitivity in comparison with radio-isotopic ISH
    • Absolute specificity – distinguish between sequences with up to 85% homology
    • Virtually no background
    • Full automation for high-throughput
    • Quantification with RNAscope® SpotStudio™ – entering the area of "digital pathology"

    And how you can use it for your specific application.

    Speaker: 
    Kai Wilkens, PhD MBA
    Senior Director Sales & Marketing, Europe Advanced Cell Diagnostics, Inc.

    Register here

     

     

  • Advanced Cell Diagnostics Announces Election of Dr. Joseph D. Keegan to its Board of Directors
    December 8, 2013

    Hayward, California – December 9, 2013 – Advanced Cell Diagnostics, Inc. (ACD), a world leader in the field of in situ nucleic acid detection for life science research and clinical diagnostics, is pleased to announce today the appointment of Joseph Keegan as a director to the company's board. In this position, Dr. Keegan will apply his extensive and successful business experience in the life science industry to help accelerate ACD's growth and expand its international presence.

    Dr. Keegan brings more than 30 years of experience managing high growth life science businesses. Dr. Keegan served as the CEO of ForteBio since September of 2007 and he built the company from a startup into a fast growing leader in label-free analysis. Under his leadership, the company generated compounded annual revenue growth of 45% to $27M. It was acquired in 2012 by Pall Corporation, returning $160M to investors. Previously, Dr. Keegan was the CEO of Molecular Devices (MDC). During his 9-year tenure at MDC, Dr. Keegan grew the company’s revenue from $30M to $185M and he sold the company to MDS for $615M in 2007. Prior to MDC, Dr. Keegan served as President of Worldwide Tissue Culture of Becton Dickinson and Vice President of Microscope and Scientific Instruments Division of Leica.

    "It is a great pleasure to welcome Dr. Keegan to our board when the company is experiencing rapid growth." said Dr. Yuling Luo, President and CEO of ACD. "Joe's remarkable success in building both ForteBio and Molecular Devices, and his extensive experience in both research and diagnostic industries make him an ideal addition to the board."

    "RNAscope technology developed by ACD is a breakthrough in situ nucleic acid detection platform with wide-ranging market opportunities in both life science research and clinical diagnostics," said Dr. Keegan. "I am very pleased to join the ACD board and look forward to helping the company in its rapid growth and expansion."

    About Advanced Cell Diagnostics, Inc.

    Advanced Cell Diagnostics, Inc. is a leader in the emerging field of molecular pathology, developing cell and tissue-based research tools for all areas of biomedical research, and diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the most sensitive method available for RNA in situ hybridization, and the first quantitative and fully automated platform enabling multiplex fluorescent and chromogenic RNA biomarker analysis. ACD partners with pharmaceutical and biotechnology companies to validate biomarkers for targeted therapeutic development in cancer and other diseases. These partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope® technology at www.acdbio.com.

    Media Contacts: 
    Steve Chen, Ph.D.
    Chief Operating Officer
    (510) 259-9802
    schen@acdbio.com

  • Advanced Cell Diagnostics Announces Genoptix® as their First CLIA Certified RNAscope® Service Provider
    November 5, 2013
    • Advanced Cell Diagnostic expands RNAscope® technology access through CLIA Service Provider Program

    HAYWARD, CA,  November 5, 2013—Advanced Cell Diagnostics, Inc. (ACD), a leader in the field of molecular pathology and developer of cell and tissue-based analysis tools, today announced that it has introduced a CLIA Certified RNAscope Service Provider program, with Genoptix® BioPharma Services , as the first to be certified. This program is designed to support clinical trials for ACD’s leading pharmaceutical clients to ensure delivery of high quality services performed within a CLIA environment. Each service provider will undergo extensive training on RNAscope technology and is required to pass a rigorous certification procedure. “ACD has established high quality performance standards through RNAscope products and services; this extension of services performed within a CLIA environment further solidifies our commitment. Genoptix is known for quality, service and expertise within the oncology arena. They are an ideal partner to initiate the launch of this program,” said Dr. Yuling Luo, President, CEO and Founder of ACD.
    RNAscope is quickly becoming a gold-standard technique to identify and validate RNA biomarkers in tissue for research, molecular diagnostics, and companion diagnostics. ACD’s pharmaceutical clients are rapidly progressing from Phase 1 testing to Phase 2 trials using RNAscope-validated biomarkers. Phase 3 clinical trial testing must be performed within a CLIA environment. “By partnering with highly qualified CLIA Service Providers, our clients can seamlessly transition validated biomarker to Phase 2 or Phase 3 trials. Partners like Genoptix ensure our clients will receive world-class service with the highest data quality necessary for clinical implementation.” said Dr. Luo. 

    About Advanced Cell Diagnostics, Inc.
    Advanced Cell Diagnostics, Inc. is a leader in the emerging field of molecular pathology, developing cell and tissue-based research tools for all areas of biomedical research, and diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the most sensitive method available for RNA in situ hybridization, and the first quantitative and fully automated platform enabling multiplex fluorescent and chromogenic RNA biomarker analysis. ACD partners with pharmaceutical and biotechnology companies to validate biomarkers for targeted therapeutic development in cancer and other diseases. These partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope® technology at www.acdbio.com.

    Media Contacts: 
    Steve Chen, Ph.D.
    Chief Operating Officer
    (510) 259-9802
    schen@acdbio.com

     

  • Advanced Cell Diagnostics and Kindstar Global Announce Partnership to Launch Cancer Diagnostic Tests in China
    October 24, 2013

    HAYWARD, CA & WUHAN, CHINA, Oct. 23, 2013—Advanced Cell Diagnostics, Inc. (ACD) and Kindstar Global (Kindstar) today announced that Kindstar will begin validating and implementing ACD’s RNAscope® technology-based molecular diagnostic assays in its clinical laboratories. The initial suite of tests to be launched include RNAscope HPV, a high-risk HPV test to determine HPV status in cervical pre-cancer and head & neck cancer, and CTCscope, a blood-based test to detect and characterize circulating tumor cells in blood. This partnership will enable Kindstar to leverage ACD’s RNA biomarker analysis platform to offer a new generation of cancer diagnostic tests to its network of more than 3,300 hospitals across China.

    "Kindstar's adoption of ACD’s RNAscope technology for advanced molecular testing in oncology attests to the broad clinical utility of RNAscope." said Dr. Yuling Luo, Founder, President and CEO of Advanced Cell Diagnostics. "RNAscope technology enables a dramatic improvement in diagnostic accuracy and confidence, especially when cellular and molecular context is required and when more sensitive technology is needed to give a conclusive result.”  

    "Kindstar is excited to offer services in China based on the most advanced RNA in situ hybridization platform in the industry.  The new RNAscope-based tests will significantly broaden Kindstar’s oncology test menu offerings. The RNAscope platform will also allow Kindstar to more rapidly translate today’s advances in cancer research into clinical practice for our physicians and patients," said Dr. Shiang Huang, Founder and CEO of Kindstar. "

    About Advanced Cell Diagnostics

    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology, developing cell and tissue-based research tools for all areas of biomedical research, and diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the most sensitive method available for RNA in situ hybridization, and the first quantitative and fully automated platform enabling multiplex fluorescent and chromogenic RNA biomarker analysis. ACD partners with pharmaceutical and biotechnology companies to validate biomarkers for targeted therapeutic development in cancer and other diseases. These partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope® technology at www.acdbio.com.

    About Kindstar Global

    Kindstar Global, with laboratory facilities in Beijing, Shanghai and Wuhan, provides esoteric diagnostic testing services to hospitals and physicians in every province of China. Kindstar is the first and largest esoteric diagnostic testing business in China, providing laboratory testing services to over 3,300 Chinese hospitals, including 930 tertiary hospitals (classification for largest leading hospitals). Kindstar is becoming the partner of choice to physicians in China for advanced diagnostics in many medical specialties including hematology, oncology, infectious diseases and medical genetics.

    Press Contact:

    Steve Chen, Ph.D.
    Chief Operating Officer
    (510) 259-9802

    schen@acdbio.com

  • Life Technologies and Advanced Cell Diagnostics Sign Global Distribution Agreement
    September 30, 2013

    CARLSBAD, CALIFORNIA, -- Sept. 30, 2013 -- Life Technologies Corporation (NASDAQ: LIFE) and Advanced Cell Diagnostics, Inc. (ACD), a leader in the field of molecular pathology and developer of cell and tissue-based analysis tools, today announced a global distribution agreement by which Life will distribute ACD’s fluorescent RNAscope® portfolio of probes and kits to the research market through its worldwide distribution network.

    Life Technologies and Advanced Cell Diagnostics Sign Global Distribution Agreement

    • Partnership makes Advanced Cell Diagnostics’ award-winning RNAscope® technology accessible to researchers worldwide
    • Expands Life Technologies’ footprint in growing tissue analysis market  

    Kits Support Growing RNA Biomarker Market, Cancer and Neurobiology Research 

    RNA biomarker discovery and validation for the tissue analysis market is growing rapidly as the transition between research and the clinic continues to accelerate.  RNAscope® is quickly becoming a gold-standard technique to identify and validate RNA biomarkers in tissue for research, molecular diagnostics and companion diagnostics. Additionally, as cancer and neurobiology research continues to grow, there has been an explosion in the discovery of biomarkers identified from microarray and next-generation sequencing (NGS) technologies.  However, for many of these biomarkers, the specific cell types in the tissue that express them remain unknown, thereby limiting the ability to fully understand biological relevance.

    “RNAscope complements our existing portfolio and solves long-standing technical hurdles researchers have encountered when studying heterogeneous samples,” says Siddhartha Kadia, Ph.D., President, Life Sciences at Life Technologies. “RNAscope’s ability to provide single-molecule RNA detection, while preserving tissue context makes it easy to pinpoint which biomarker is expressed in specific cells -- all at the convenience of a conventional fluorescence microscope.”

    RNAscope features exceptional levels of sensitivity, specificity, and the ability to multiplex -- making it a breakthrough technology for localizing and measuring RNA in situ in unprecedented detail. It addresses many bottlenecks that arise due to lack of antibodies, and complements both NGS and qPCR methods by revealing the valuable, morphological context of newly identified biomarkers in both cells and complex tissues.

    “Advanced Cell Diagnostics is delighted that RNAscope products will be introduced into multiple markets through Life Technologies extensive distribution networks,” said Yuling Luo, Founder, President & CEO, Advanced Cell Diagnostics. “Life Technologies has a legacy of introducing cutting-edge technologies to their customers and we are excited to have them represent RNAscope.”

      

    About Life Technologies

    Life Technologies Corporation (NASDAQ: LIFE) is a global biotechnology company that is committed to providing the most innovative products and services to leading customers in the fields of scientific research, genetic analysis and applied sciences. With a presence in more than 180 countries, the company's portfolio of 50,000 end-to-end solutions is secured by more than 5,000 patents and licenses that span the entire biological spectrum—scientific exploration, molecular diagnostics, 21st century forensics, regenerative medicine and agricultural research. Life Technologies has approximately 10,000 employees and had sales of $3.8 billion in 2012.

     

    Life Technologies' Safe Harbor Statement

    This press release includes forward-looking statements about our anticipated results that involve risks and uncertainties. Some of the information contained in this press release, including, but not limited to, statements as to industry trends and Life Technologies' plans, objectives, expectations and strategy for its business, contains forward-looking statements that are subject to risks and uncertainties that could cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Any statements that are not statements of historical fact are forward-looking statements. When used, the words "believe," "plan," "intend," "anticipate," "target," "estimate," "expect" and the like, and/or future tense or conditional constructions ("will," "may," "could," "should," etc.), or similar expressions, identify certain of these forward-looking statements. Important factors which could cause actual results to differ materially from those in the forward-looking statements are detailed in filings made by Life Technologies with the Securities and Exchange Commission. Life Technologies undertakes no obligation to update or revise any such forward-looking statements to reflect subsequent events or circumstances.

     

    About Advanced Cell Diagnostics, Inc.

    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology, developing cell and tissue-based research tools for all areas of biomedical research, and diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the most sensitive method available for RNA in situ hybridization, and the first quantitative and fully automated platform enabling multiplex fluorescent and chromogenic RNA biomarker analysis. ACD partners with pharmaceutical and biotechnology companies to validate biomarkers for targeted therapeutic development in cancer and other diseases. These partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope® technology at www.acdbio.com.

     Media Contacts:

    Mauricio Minotta

    Life Technologies Corp.

    760-929-2456

    Mauricio.minotta@lifetech.com

    Steve Chen

    Advanced Cell Diagnostics Inc.

    510-259-9802

    schen@acdbio.com

     

  • Advanced Cell Diagnostics is Pleased to Announce the launch of their New Website
    June 20, 2013

    HAYWARD, CALIFORNIA–June 18, 2013–Advanced Cell Diagnostics, Inc. (ACD), a biotechnology company developing cell and tissue-based diagnostic tests for personalized medicine, today announced the launch of their newly designed website at www.acdbio.com. The website is designed with a fresh new look and user-friendly navigation and is updated with the latest information about RNAscope® products and services.

    The new site offers easier online quote request, improved multi-species target probe search capability, and a blog corner that provides the latest information about RNAscope® products and services. In addition, there is an updated application, documentation and support library, interactive FAQ community, webinars, and online training presentations. For more information about the website, visit the ACD blog at www.acdbio.com/about/blog.

    About RNAscope®

    RNAscope® technology is the first automated multiplex RNA in situ hybridization platform capable of detecting and quantifying biomarkers with single-molecule sensitivity. Traditionally, RNA biomarkers are analyzed by "grind-and-bind" assays such as RT-PCR in homogenized tissue, which loses information about cellular context and disease microenvironment that is critical for clinical interpretation. RNAscope® provides single-cell gene expression information within the context of intact tissue, enabling both molecular and histopathological analysis on a platform that is compatible with routine clinical specimens and standard clinical laboratory workflow. Unlike IHC antibodies which are available for only a small fraction of the human proteome and not suitable for the emerging class of non-coding RNAs, RNAscope® assays can be developed and validated in two weeks for virtually any gene in any genome. Currently, ACD offers RNAscope-based products and services worldwide to scientists in a broad range of research areas from basic research to companion diagnostics for personalized medicine. Customers include world-renowned academic institutions and all major pharmaceutical/biotech companies.

    About Advanced Cell Diagnostics

    Advanced Cell Diagnostics, Inc. is a leader in the emerging field of molecular pathology, developing cell and tissue-based diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first automated multiplex chromogenic and fluorescent in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single-molecule sensitivity. RNAscope® assays are currently used by hundreds of customers, including all of the global top 10 pharmaceutical companies, world leading academic institutions and many cutting edge biotechnology companies to validate biomarkers for the management of cancer and other diseases. ACD’s industrial partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop and commercialize proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope® technology at www.acdbio.com.

    Press Contact:

    Steve Chen, Ph.D.
    Chief Operating Officer
    (510) 259-9802

    schen@acdbio.com

  • PerkinElmer and Advanced Cell Diagnostics Enter Into Co-Marketing Agreement – Sign up for Live Webinar
    June 19, 2013

    On May 8 & 9, 2013 we held the latest of our Revolutionaries for Global Health Summit in Newton, MA where over 500 scientists joined us to discuss how disruptive technologies are being used to advance human health. With over 60 speakers and 6 scientific tracks this was a very dynamic meeting where many ideas were shared and new collaborations formed, with the common goal of improving detection and treatment of disease.

    One of the collaborations which most excited us was the announcement that PerkinElmer and Advanced Cell Diagnostics (ACD) had entered a co- marketing agreement. After the announcement, Dr Yuling Luo, CEO and Founder of ACD explained how their multiplexed RNAScope® assays are being used to detect biomarkers in tissues.

    As part of this new collaboration we are planning to develop joint applications for the visualization of multiplexed fluorescence RNA biomarkers in situ, in formalin-fixed paraffin-embedded tissues. This is very exciting as in the past this it has not been possible to detect and quantify RNA in situ in these pathological samples due to lack sensitivity and specificity of labels within highly autofluorescent tissues. By combining the latest RNAscope® multiplexed fluorescence assays from ACD with multispectral imaging technologies from PerkinElmer, we have already shown simultaneous gene expression of multiplexed RNA biomarkers in FFPE tissues. Over the coming months we will be working to further develop applications which will provide morphological context to support genomic analysis of biomarkers.

    Contact us for more information or to be kept updated on these developments.

    Join us for our webinar, "Multiplex RNA Biomarker Visualization in Cells, Fresh Frozen and FFPE Tissue", Wednesday 24 July 2013 11am EDT/ 4pm GMT

  • Advanced Cell Diagnostics is a Finalist for the 2013 Red Herring Top 100 North America Award
    June 10, 2013

    HAYWARD, CALIFORNIA–Advanced Cell Diagnostics, Inc. (ACD), a biotechnology company that manufactures life science reagents for basic biomarker research and cell and tissue-based diagnostic tests, announced today it had been selected as a Finalist for Red Herring's Top 100 North America award, a prestigious list honoring the year’s most promising private ventures from the North American business region.

    "We are very pleased to be named a Red Herring Top 100 North America Finalist and be recognized along with other innovative startups. ," said Dr. Yuling Luo, founder and chief executive officer of ACD. Dr. Luo added, "This recognition further validates our innovative RNAscope® technology that will unlock the full potential of RNA biomarkers for personalized medicine."

    Red Herring has been selecting the most exciting and promising start-ups and "scale ups" since 1995. Finalists are still evaluated individually from a large pool of hundreds of candidates based across North America. Twenty major criteria underlie the scoring and process. They include, among others: the candidate company's addressable market size, its IP and patents, its financing, the proof of concept, trailing revenues and management's expertise. Each company goes through an individual interview after filling out a thorough submission, complemented by a due diligence. The list of finalists often includes the best performing and prominent companies of that year.

    2013 will be remembered as a special vintage. "The finalists list confirms the excellent choices made by entrepreneurs and VCs and the start-ups' solid roots in corporate America, embracing their innovations. By all metrics, it emphasizes the United States’ entrepreneurial excellence," said Alex Vieux, publisher and CEO of Red Herring.

    Finalist selections for the 2013 edition of the Red Herring 100 North America award are based upon technological innovation, management strength, market size, investor record, customer acquisition and financial health. During the several months leading up to the announcement, hundreds of companies in the fields of security, Web 2.0, software, hardware, life sciences, cloud, mobile and others completed their submissions to qualify for the award.

    About Advanced Cell Diagnostics

    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology, developing cell and tissue-based diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first automated multiplex chromogenic and fluorescent in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single-molecule sensitivity. RNAscope® assays are currently used by hundreds of customers, including all of the global top 10 pharmaceutical companies, world leading academic institutions and many cutting edge biotechnology companies to validate biomarkers for the management of cancer and other diseases. ACD’s industrial partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop and commercialize proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope® technology at www.acdbio.com.

    Press Contact:
    Steve Chen, Ph.D.
    Chief Operating Officer
    (510) 259-9802
    schen@acdbio.com

  • Advanced Cell Diagnostics Initiates Agreement to Study Biomarkers for Cancer Immunotherapy
    March 11, 2013

    Hayward, CA — March 4, 2013 — Advanced Cell Diagnostics, Inc. (ACD) announced today that they have entered into an agreement with The Johns Hopkins University on behalf of its Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins to use ACD’s proprietary RNAscope® technology platform to validate novel biomarkers and drug targets for cancer immunotherapy.

    Cancer immunotherapy, which aims to mobilize a patient’s immune system to fight cancer, has been gaining momentum recently with the FDA approval of anti-CTLA-4 therapy for melanoma and with the recent impressive and durable remissions produced by targeting PD1 in multiple solid tumors in early-phase clinical trials led by Johns Hopkins investigators. With many additional immune modulatory molecules identified for targeting that play major roles in specific subsets of cancer, it will be critical to develop standardized biomarkers to guide the application of the most effective immune therapies on a patient-by-patient basis.

    Targeting the immune checkpoints that are often suppressed in many cancers has demonstrated tremendous potential. However, to identify biomarkers useful for guiding therapy, conventional approaches to biomarker analysis have proven inadequate, leading to conflicting results.

    “The complex interplay between cancer cells and the immune system in the tumor microenvironment matches perfectly with RNAscope’s capability of single molecule sensitivity and single cell resolution, which can help pinpoint which cell is talking to which other cell,” said Dr. Yuling Luo, Founder, President and CEO of ACD. Dr. Luo added, “That knowledge will be essential for selecting optimal targets for drug development and predicting which patient will benefit from it. We feel extremely fortunate to be able to provide such a tool to the pioneers in this emerging and exciting field.”

    About RNAscope

    RNAscope technology is the first automated multiplex RNA in situ hybridization platform capable of detecting and quantifying biomarkers with single-molecule se nsitivity. Traditionally, RNA biomarkers are analyzed by “grind-and-bind” assays such as RT-PCR in homogenized tissue, which loses information about cellular context and disease microenvironment that is critical for clinical interpretation. RNAscope provides single-cell gene expression information within the context of intact tissue, enabling both molecular and histopathological analysis on a platform that is compatible with routine clinical specimens and standard clinical laboratory workflow. Unlike IHC antibodies which are available for only a small fraction of the human proteome and not suitable for the emerging class of non-coding RNAs, RNAscope assays can be developed and validated in two weeks for virtually any gene in any genome. Currently, ACD offers RNAscope-based products and services worldwide to scientists in a broad range of research areas from basic research to companion diagnostics for personalized medicine. Customers include world-renowned academic institutions and all major pharmaceutical/biotech companies.

    About Advanced Cell Diagnostics

    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology, developing cell and tissue-based diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first automated multiplex chromogenic and fluorescent in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single - molecule sensitivity. RNAscope assays are currently used by hundreds of customers, including all of the global top 10 pharmaceutical companies, world leading academic institutions and many cutting edge biotechnology companies to validate biomarkers for the management of cancer and other diseases. ACD’s industrial partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop and commercialize proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope technology at www.acdbio.com.

  • Definiens and Advanced Cell Diagnostics Introduce RNAscope® SpotStudio - Early Access Program Started
    February 12, 2013

    Quantitative biomarker analysis advanced by alliance between Advanced Cell Diagnostics and Definiens, providers of breakthrough platform for in situ RNA biomarker detection and leading image analysis technology for digital pathology

    Munich, Germany
    Hayward, California, USA

    Feb 12, 2013 – Definiens and Advanced Cell Diagnostics (ACD) today unveiled the details of the RNAscope® SpotStudio™ image analysis software to attendees at the Molecular Medicine Tri-Conference meeting in San Francisco, USA. The software has already been sold to a top pharmaceutical company and a leading academic medical center under an early access program. This advanced image analysis solution brings objective and accurate quantification to RNA in situ hybridization and enables a new generation of diagnostic applications based on single cell analysis. For the first time, gene expression can be measured quantitatively at single-cell resolution and interpreted by pathologists within his topathological context.

    Empowering Pathologists with an Easy-to-Use Tool for Quantitative Biomarker Analysis Quantitative RNA in situ hybridization analysis has recently been made possible by the single molecule sensitivity and digital nature of RNAscope® assay technology. However, manual scoring is time consuming and prone to subjectivity and poor reproducibility.

    RNAscope® SpotStudio™ software is designed for pathologists with no prior training in image analysis. It is an intuitive automated solution that generates standardized and objective results in minutes. Testing has shown that results obtained with RNAscope® SpotStudio™ are comparable to careful manual annotations by pathologists. The software is compatible with image data from whole slide scanners and microscopes.

    In situ biomarker analysis tools such as immunohistochemistry (IHC) have been limited to subjective semi-quantitative scoring. RNAscope® and the SpotStudio™ image analysis software take in situ biomarker analysis to a whole new level, where quantitative data at the single cell level can be obtained and interpreted within the histopathological context of the clinical specimen”, said Yuling Luo, Founder, President and CEO of ACD.

    “RNAscope® combines the advantages of IHC and PCR, making it a superior tool for tissue-based diagnostics and companion diagnostics”, Dr. Luo added. "Definiens" invaluable expertise with tissue image analysis made it an ideal partner for the joint development of RNAscope® SpotStudio™.

    Coming from a leading position in providing image analysis solutions to the life sciences market, Definiens is rapidly expanding its footprint in tissue diagnostics. We are very excited about this partnership with ACD representing a great example of advanced diagnostic solutions based on Definiens image and data analysis capabilities that will drive next generation diagnostics to truly enable personalized medicine”, said Thomas Heydler, CEO of Definiens.

    Definiens and ACD will showcase RNAscope® SpotStudio™ at the Molecular-Med Tri- Con in San Francisco (booth 210). The solution will be marketed and distributed by ACD and is currently being distributed to selected customers in an early access program. General availability is planned for the second quarter of 2013. While RNAscope® SpotStudio™ supports the analysis of brightfield images, RNA FISH assays can be quantified with Definiens Tissue Studio. With over 450 deployed licenses, Definiens Tissue Studio is the leading image analysis solution for digital pathology. Beyond the detection of spot-like stains, Definiens Tissue Studio provides morphological and molecular expression profiles from any solid tissue (IHC and IF) on a cell-by-cell basis.

    About Definiens

    Definiens is the leading provider of image analysis and data mining solutions for life sciences, tissue diagnostics and clinical digital pathology. Definiens software provides detailed cell-by-cell readouts from target structures on whole tissue slides, and allows the correlation of this information with data derived from other sources. By automating analysis workflows, Definiens helps pharmaceutical and biotechnology companies, research institutions, clinical service organizations and pathologists to generate new knowledge and support better decisions in research, diagnostics and therapy.

    Definiens’ vision is to open new fields of research, to contribute to development of personalized medicine and to significantly improve the quality of patients’ lives. Definiens is headquartered in Munich, Germany and has offices throughout the United States. Further information is available at www.definiens.com.

    About Advanced Cell Diagnostics

    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology, developing cell and tissue-based research tools for all areas of biomedical research, and diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the most sensitive method available for RNA ISH, and the first quantitative and fully automated platform enabling multiplex fluorescent and chromogenic RNA biomarker analysis. ACD partners with pharmaceutical and biotechnology companies to validate biomarkers for targeted therapeutic development in cancer and other diseases. These partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal progr ams to develop proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope® technology at www.acdbio.com.

    Media Contacts

    Definiens AG
    Dr Florian Leiss
    Manager Marketing Communications
    +49 (89) 2311-8024
    fleiss@definiens.com
     

    Advanced Cell Diagnostics

    Steve Chen, PhD
    Chief Operating Officer
    +1 (510) 259-9802
    schen@acdbio.com

  • Advanced Cell Diagnostics Appoints Evangeline Gonzalez as Chief Commercial Officer
    January 25, 2013

    Hayward, CA — January 25, 2013 — Advanced Cell Diagnostics, Inc., a world leader in the field of in situ nucleic acid detection for life science research and clinical diagnostics, today announced the appointment of Evangeline Gonzalez to its executive leadership team as Chief Commercial Officer. In this role, Mrs. Gonzalez will lead the company’s global commercialization efforts. Mrs. Gonzalez will report directly to Advanced Cell Diagnostics CEO, Yuling Luo, Ph.D. “It was the breakthrough technology and the multi-talented team that attracted me to Advanced Cell Diagnostics. I’m so excited to join the team to help grow the company to the next level,” Mrs. Gonzalez said.

    Mrs. Gonzalez has more than 17 years of commercialization experience in the biotechnology industry. She joins Advanced Cell Diagnostics from Life Technologies (formerly Applied Biosystems and Invitrogen), a 3.7 billion dollar company, where she was most recently Chief Marketing Officer of the Life Sciences Division. In this role, she was responsible for facilitating growth, marketing and global market development strategy.

    Previously she was Vice President of Market Development and Product Management for several businesses within Life Technologies including Protein Analysis, Sequencing and Molecular Biology Systems. In these roles, she was responsible for driving revenue growth for both existing products and commercializing new breakthrough technologies globally.

    “Advanced Cell Diagnostics has achieved several important milestones over the last 3 months including closing a $12 million financing round, successfully introducing our automated RNAscope® solution and expanding our commercial team,” said Dr. Luo. “ Evangeline’s proven track record of commercializing new technologies and her leadership skills are exactly what we need at this phase of our company’s growth,” Dr. Luo continued.

    About Advanced Cell Diagnostics

    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology, developing cell and tissue-based diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first multiplex chromogenic and fluorescent in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single-molecule sensitivity. RNAscope® assays are currently used by hundreds of customers, including all of the global top 10 pharmaceutical companies, world leading academic institutions and many cutting edge biotechnology companies to validate biomarkers for the management of cancer and other diseases. ACD’s industrial partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope® technology at www.acdbio.com.

    Contact:
    Steve Chen, Ph.D.
    Chief Operating Officer
    (510) 259-9802
    schen@acdbio.com

  • Advanced Cell Diagnostics Completes $12 Million Series B Financing
    November 1, 2012

    Hayward, CA – November 1, 2012 – Advanced Cell Diagnostics, Inc., a world leader in the field of in situ nucleic acid detection for life science research and clinical diagnostics, announced today that it has completed its $12 million Series B equity financing. New Leaf Venture Partners, a leader in healthcare technology venture investing, and the existing investor Morningside Ventures participated in the round. Proceeds from the financing will be used to support the commercial expansion of its proprietary technology RNAscope®‐based products and services into the life science research market and accelerate the entry of RNAscope® into the clinical diagnostics market.

    “New Leaf is excited to partner with ACD. Immunohistochemistry and FISH are well established technologies to monitor proteins and DNA respectively and each represents more than a billion dollar market today. ACD’s technology is the first that we have seen which allows researchers to robustly visualize and quantify RNA in tissue. As such, we expect it to open up a large untapped market and become a mainstay in basic and translational research, while at the same time accelerating the development of advanced diagnostics,” said Dr. Michael Dybbs, Principle of New Leaf Venture Partners. “We have been most impressed by ACD’s success in achieving all of its major milestones in the past four years. The RNAscope® technology has proven to be a game changer in biomarker research and promises a new paradigm shift in clinical diagnostics development," said Dr. Gerald Chan, Co‐Founder of Morningside Ventures.

    “This oversubscribed round of financing is an important validation of the market potential of our RNAscope® technology and it underscores the promise of our RNAscope®‐based diagnostic pipeline,” said Dr. Yuling Luo, Founder, President and CEO of ACD, “We now have the resources to take ACD to the next level.”

    About RNAscope

    RNAscope® technology is the first automated multiplex in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single‐molecule sensitivity. Traditionally, RNA biomarkers are analyzed by “grind‐and‐bind” assays such as RT‐PCR, which lose cellular context critical for clinical interpretation. RNAscope® provides single‐cell gene expression information within full cellular and tissue context and is compatible with routine clinical specimen and standard clinical laboratory workflow. Unlike antibodies which are available for only a small fraction of the human proteome and not suitable for the emerging class of non‐coding RNAs, RNAscope® assays can be developed within two weeks for virtually any gene in the human genome regardless of its coding potential. Currently, ACD offers RNAscope®‐based products and services worldwide to scientists in a broad range of research areas from basic research to companion diagnostics for personalized medicine. Customers include many world‐renowned academic institutions and all major pharmaceutical/biotech companies.

    About Advanced Cell Diagnostics

    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology, developing cell‐ and tissue‐based diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first multiplex fluorescent and chromogenic in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single‐molecule sensitivity. ACD partners with pharmaceutical and biotechnology companies to validate biomarkers for targeted therapeutic development in cancer and other diseases. These partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop proprietary diagnostic tests in cancer management.

    ###

    Contact:
    Steve Chen, Ph.D. Chief Operating Officer
    (510) 259-9802
    schen@acdbio.com

  • Ventana Medical Systems, Inc. and Advanced Cell Diagnostics Enter Worldwide Co-Promotion Agreement for Fully Automated RNA in Situ Hybridization Assay Systems
    December 13, 2011

    Tucson, AZ — December 13, 2011) — Ventana Medical Systems Inc. (Ventana), a member of the Roche Group, and Advanced Cell Diagnostics Inc. (ACD), announced today they have entered a worldwide co-promotion agreement for the first commercially available, fully automated RNA in situ hybridization (ISH) assay system capable of robust detection and visualization of virtually any expressed gene in routine clinical specimens at single-molecule sensitivity.

    The two companies have partnered to automate this assay system on the VENTANA DISCOVERY series slide staining platforms. The product offerings are expected to become commercially available in the first quarter of 2012 and will initially be offered for research-use only (RUO) applications.

    Given the fact that the majority of biomarkers are discovered from genomic research and are RNA by nature, the automation of RNAscope® represents an important milestone that will accelerate biomarker research into a new level of sophistication,” said Dr. Yuling Luo, founder, president and CEO of ACD. “RNAscope® will become an equally indispensable tool alongside immunohistochemistry, fluorescence in situ hybridization and polymerase chain reaction for researchers in life sciences and drug development.”

    Luo said the ability to generate robust and reproducible results from routine clinical specimens “makes the technology a compelling platform for clinical diagnostic applications in the foreseeable future.”

    The RNAscope® FFPE Reagent Systems automated on the VENTANA DISCOVERY ULTRA and DISCOVERY XT offers researchers a powerful tool with unprecedented levels of performance.

    “The combination of RNAscope® reagent system and our sophisticated and flexible DISCOVERY platform and detection systems delivers a powerful solution for biomarker discovery and validation,” said Bill Crawford, director of marketing, Discovery, with Ventana. “It has significant potential to advance cell- and tissue-based biomarker analyses for future clinical and companion diagnostics development.”

    RNA in situ hybridization is an indispensable method to analyze gene expression in the context of tissue architecture in areas of oncology, virology, and neuroscience research. RNAscope® is an award-winning breakthrough technology that provides researchers the unique capability to interrogate the function and disease relevance of any expressed genes in situ, especially for the approximately 5,000 genes and 15,000 non-coding RNAs in the human genome where no other technologies can adequately address. In addition, RNAscope® allows researchers to tap into the estimated 400 million clinically-annotated, archived formalin-fixed paraffin-embedded (FFPE) tissue specimens for retrospective clinical studies in translational research.

    The DISCOVERY XT and DISCOVERY ULTRA systems provide scientists and research professionals who require more than conventional IHC and ISH research methods with an array of fully automated applications, which improve flexibility and freedom and provide the necessary, reproducible results that optimize patient care.

    About Advanced Cell Diagnostics, Inc.

    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology, developing cell- and tissue-based diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first multiplex fluorescent and chromogenic in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single-molecule sensitivity. ACD partners with pharmaceutical and biotechnology companies to validate biomarkers for targeted therapeutic development in cancer and other diseases. These partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope® technology at www.acdbio.com.

    About Ventana Medical Systems, Inc.

    Ventana Medical Systems, Inc. (“VMSI”) (SIX: RO, ROG; OTCQX: RHHBY), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. VENTANA solutions are used in clinical histology and drug development research laboratories worldwide. The company’s intuitive, integrated staining, workflow management platforms, and digital pathology solutions optimize laboratory efficiencies to reduce errors, support diagnosis and inform treatment decisions for anatomic pathology professionals. Together with Roche, VMSI is driving personalized medicine through accelerated drug discovery and the development of “companion diagnostics” to identify the patients most likely to respond favorably to specific therapies. Visit www.ventana.com to learn more.

    RNAscope® products are for research use only and not intended for diagnostic applications.

    RNAscope®, HybEZ, CTCscope, and DNAscope are registered trademarks or trademarks of Advanced Cell Diagnostics, Inc. in the United States or other countries. All other trademarks are the property of their respective owners.

    Ventana products are for in vitro diagnostic use for specific applications and are research use only for other applications. The VENTANA DISCOVERY products are for research use only. Not for use in diagnostic procedures.

    VENTANA, the VENTANA logo and DISCOVERY are trademarks of Roche.

  • Frost & Sullivan Lauds Advanced Cell Diagnostics for its Highly Innovative in Situ Biomarker Detection Assay Kit
    November 10, 2011

    RNAscope provides the first opportunity to profile single cell gene expression in situ, unlocking the full potential of RNA biomarkers for personalized medicine

    MOUNTAIN VIEW, Calif. — November 10, 2012 — Based on its recent analysis of the in situ biomarker detection assay market, Frost & Sullivan recognizes Advanced Cell Diagnostics, Inc. with the 2011 North American Frost & Sullivan Technology Innovation Award for its RNAscope® platform.

    Advanced Cell Diagnostics’ RNAscope® formalin-fixed and paraffin-embedded (FFPE) Assay Kit, a novel multiplex nucleic acid in situ hybridization technology, is based on a proprietary and unique probe design and signal amplification methodology. It is designed to detect RNA biomarkers in routine FFPE tissue specimens with single molecule sensitivity and at single cell resolution. “RNAscope® provides the first opportunity to profile single cell gene expression in situ, leveraging the full potential of RNA biomarker technology,” said Frost & Sullivan Senior Research Analyst Cecilia Van Cauwenberghe. “This technology offers unique opportunities by targeting the molecular signature of every cell within the intricate cellular structure and tissue architecture evidenced in clinical specimens.”

    Furthermore, the RNAscope® technology platform excels over conventional assays by reaching significantly high levels of specificity and sensitivity in detecting virtually any gene in the human transcriptome in situ, while simultaneously enabling quantification of multiple mRNA transcripts at a single cell level. This constitutes a paradigm shift in molecular pathology and represents a breakthrough in personalized medicine.

    RNAscope® offers end-users an enhanced toolset for research and development applications and their further translation to clinical diagnostics. Among its advantages are rapid assay development; ultimate sensitivity, including single molecule detection in situ; high specificity, allowing the distinguishing of highly homologous genes; and multiplexing capability through the simultaneous detection of multiple targets.

    “Other strengths include quantitative analysis, enabling the detection of each target to be quantified on a per cell basis,” said Cecilia Van Cauwenberghe. “In addition, it offers colorimetric or fluorescent readout under bright field or fluorescent microscope, broad sample type spectrum, as well as speed and throughput compatibility with fully automated walk away assay systems.” RNAscope® offers end-users high levels of flexibility and customization capabilities that adapt and evolve with the drug discovery and development process, significantly contributing to the acceleration of biomarker validation.

    “The technology has been demonstrated to achieve RT-PCR-level sensitivity and specificity,” said Cecilia Van Cauwenberghe. “RNAscope® is viewed as being over 100-fold more sensitive than traditional non-isotopic ISH methods.”

    In the near future, RNAscope® can be deployed by pathologists as part of their laboratory routine for molecular diagnostics. According to a recent clinical study utilizing RNAscope® technology to detect human papillomavirus (HPV) E6/E7 mRNA in routine clinical specimens of head and neck cancer, the HPV status determined by the RNAscope® HPV test was highly In recognition of these features, Frost & Sullivan is proud to present Advanced Cell Diagnostics, Inc. with the 2011 Technology Innovation Award in the North American in situ biomarker detection assay market. Each year, Frost & Sullivan presents this award to the company that demonstrates uniqueness in developing a technology, which significantly impacts both the functionality and the customer value of new products and applications. The award lauds the relevance of the innovation to the industry.

    Frost & Sullivan’s Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis and extensive secondary research to identify best practices in the industry.

    About Advanced Cell Diagnostics, Inc.

    Headquartered in Hayward, California, Advanced Cell Diagnostics, Inc. (ACD) has positioned as a leader in the emerging field of molecular pathology, through its innovative developments in cell- and tissue-based diagnostic tests for personalized medicine. The Company’s proprietary technology, RNAscope®, represents the first multiplex fluorescent and chromogenic in situ hybridization platform focus on the detection and quantification of RNA biomarkers in situ at single molecule level. ACD is committed in the validation of biomarkers for targeted therapeutic developments in cancer and other diseases. Responsible collaboration lines with pharmaceutical and biotechnology companies provides the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics, in addition to ACD’s internal programs to develop proprietary diagnostic tests.

    About Frost & Sullivan

    Frost & Sullivan, the Growth Partnership Company, enables clients to accelerate growth and achieve best-in-class positions in growth, innovation and leadership. The company's Growth Partnership Service provides the CEO and the CEO's Growth Team with disciplined research and best-practice models to drive the generation, evaluation, and implementation of powerful growth strategies. Frost & Sullivan leverages 50 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from more than 40 offices on six continents. To join our Growth Partnership, please visit http://www.awards.frost.com.

    Media Contact:

    Mireya Espinoza
    P: 210. 247.3870
    F: 210.348.1003
    E: mireya.espinoza@frost.com

  • Advanced Cell Diagnostics and Definiens Partner to Develop Tool for Quantitative Biomarker Analysis
    March 3, 2011

    RNAscope, ACD’s in situ RNA biomarker analysis and diagnostics platform, will be paired with Definiens’ proprietary image analysis technology to advance personalized medicine in oncology. Technology on display at AACR.

    Hayward, CA / Munich, Germany – March 31, 2011 – Advanced Cell Diagnostics (ACD), a technological leader in molecular pathology, and Definiens, a leading provider for biomedical image and data analysis, announce today a strategic partnership to develop image analysis applications that will enable researchers to accurately quantify specific RNA molecules within individual cells in routine clinical specimen. The partnership will build on ACD’s RNAscope® platform and add new specialized image analysis solutions that will automatically process and analyze images from RNAscope® assays. The software system will significantly enhance the utility of RNAscope®-based diagnostic tests for personalized medicine. ACD will demonstrate the technology at booth #413 of the 2011 AACR conference in Orlando, FL on April 3 - 6.

    ACD’s RNAscope® is a novel and proprietary RNA in situ hybridization (ISH) method that can detect and quantify virtually any expressed gene at single molecule sensitivity in individual cells in all major biological specimen types, including cell lines, PBMC and FFPE tissue sections. As the most clinically robust RNA ISH assay available, RNAscope® enables the fastest path from genomic discovery to validated biomarkers and clinical diagnostic tests.

    Under the agreement, Definiens will develop a unique and proprietary image analysis application for ACD that provides users with powerful analysis capabilities. Definiens software, based on its Definiens XD framework, offers users with accurate, robust and scalable image analysis solutions for a wide range of histology analysis.

    “The partnership between Advanced Cell Diagnostics and Definiens will combine two powerful technologies in the promising field of RNA biomarker identification and development,” said Thomas Heydler, CEO of Definiens. “With our image intelligence technology’s superior accuracy and multiplexing capabilities, Definiens is uniquely suited to help Advanced Cell Diagnostics create powerful RNA assays that can further support personalized medicine initiatives around the world.”

    “This advanced image analysis solution will bring objective and accurate quantification to RNAscope® and enable a new generation of diagnostic applications such as circulating tumor cell detection and molecular analysis. For the first time, gene expression can be measured quantitatively at single cell resolution and interpreted by pathologists within histopathological context,” said Dr. Yuling Luo, Founder, President and CEO of ACD.

    About Advanced Cell Diagnostics

    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology, developing cell- and tissue-based diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first multiplex fluorescent and chromogenic in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single molecule sensitivity. ACD partners with pharmaceutical and biotechnology companies to validate biomarkers for targeted therapeutic development in cancer and other diseases. These partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop proprietary diagnostic tests in cancer management.

    About Definiens

    Definiens is a leading Health Image IntelligenceTM company that develops software solutions for biomedical image analysis, data mining and clinical decision support. The company’s software analyzes images from cell-based assays, whole tissue slides and full body scans and allows users to correlate this information with data derived from other sources, supporting better decisions in research, diagnostics and therapy. By automating analysis workflows and generating new knowledge, Definiens provides pharmaceutical and biotechnology companies, research institutions, clinical service organizations and medical professionals with deeper insights, faster results and better decision support. Harnessing the power of image intelligence, Definiens supports personalized medicine and aims to significantly improve the quality of patients’ lives.

    Definiens is headquartered in Munich, Germany, and has offices throughout the United States. Further information is available at www.definiens.com.

    Definiens – from images to clinical decisions.

    Definiens, Definiens Cognition Network Technology, Definiens Cellenger, Definiens Tissue Studio, Definiens LymphExpert, Enterprise Image Intelligence, Health Image Intelligence and Understanding Images are trademarks or registered trademarks of Definiens

    Press Contacts

    Advanced Cell Diagnostics Steve Chen

    (510) 576-8800 x102

    schen@acdbio.com

    Definiens

    Martin Baatz

    mbaatz@definiens.com

    Ricochet Public Relations John Abrashkin

    (212) 679 3300 x121

    jabrashkin@ricochetpr.com

  • ACD Announces Clinical Study Results Using its RNAscope® Technology
    February 28, 2011

    San Antonio, TX — February 28th, 2011 — Advanced Cell Diagnostics, Inc. (ACD) today announced the results of its clinical study utilizing RNAscope® technology to detect human papillomavirus (HPV) E6/E7 mRNA in routine clinical specimens of head and neck cancer. HPV status determined by the RNAscope® HPV test was highly predictive of patient outcome and highly concordant with that determined by existing methods. Significantly, the RNAscope® test under development demonstrated 16% higher detection sensitivity than the HPV DNA test used in the study.

    These results will be presented today at the 100th Annual Meeting of United States & Canadian Academy of Pathology (USCAP 2011). The RNAscope® HPV test detects E6/E7 mRNA from seven high risk HPV genotypes known to be associated with certain head and neck cancers. The study included 211 head and neck cancers from the oropharynx (base of tongue and throat). It compared the RNAscope® test with two other tests detecting HPV DNA and the cellular protein p16. RNAscope® identified 78% of the cases to be positive for HPV, compared to 62% and 79% by the HPV DNA and p16 assays, respectively. HPV-positive tumors as determined by RNAscope® were associated with 77% lower risk of death following standard therapies (hazard ratio = 0.23, p < 0.001 for overall survival and disease-specific survival), compared to HPV- negative tumors.

    “To determine whether a tumor is caused by HPV, it requires more than just detecting the presence or absence of the virus. Detecting transcriptionally active HPV in the tumor cells is critical to establish its presence as clinically significant “, said Dr. James Lewis Jr. of Washington University in St. Louis, the principal investigator in this collaborative study. “The RNAscope® assay uniquely addresses this clinical need by detecting the viral E6/E7 mRNAs and allowing their direct visualization in the tumor cells”, continued Dr. Lewis.

    “The incidences of HPV-associated head and neck cancers are increasing rapidly in the US and worldwide, and the clinical community has been looking for a robust, definitive HPV test “, said Dr. Xiao-Jun Ma, Chief Scientific Officer of ACD, “E6/E7 mRNA has long been recognized as the best biomarker for HPV-associated cancers, but its detection by RT-PCR has been limited to research use only due to the complexity of dealing with formalin-fixed paraffin-embedded (FFPE) tissue specimens. This study demonstrated that RNAscope® is well suited for bringing E6/E7 mRNA testing into the clinic.”

    “ACD aims to empower pathologists in molecular diagnostics by making RNAscope® seamlessly compatible with routine FFPE tissue specimen and with existing workflow in pathology labs.” Commented by Dr. Yuling Luo, President & CEO of ACD. Dr. Luo continued, “The outcome of this study is the first concrete evidence that we have made significant progress toward this goal.”

    About head and neck cancer:

    Head and neck cancer comprises cancers arising in the head and neck area, e.g., mouth, nose, throat, etc. It has an estimated incidence of approximately 50,000 in the US and 400,000 worldwide each year. Traditional risk factors for head and neck cancers are mainly tobacco smoking and alcohol drinking. Recently, a subset of head and neck cancers, especially those from the oropharynx, has been shown to be associated with the sexually transmitted human papillomavirus (HPV). HPV-associated cancers are both biologically and clinically different from those unrelated to HPV: they usually carry wild type p53 and do not overexpress EGFR, present in younger men, and have a more favorable prognosis, probably due to their higher sensitivity to radiation and chemotherapy. Because of these differences, clinical trials are being designed specifically for HPV-associated oropharyngeal tumors and for HPV-unrelated tumors to optimize therapies based on HPV status.

    About Advanced Cell Diagnostics

    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology, developing cell- and tissue- based diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first multiplex fluorescent and chromogenic in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single molecule sensitivity. ACD partners with pharmaceutical and biotechnology companies to validate biomarkers for targeted therapeutic development in cancer and other diseases. These partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop proprietary diagnostic tests in cancer management.

  • ACD Wins $3 Million Grant from National Cancer Institute to Develop its CTCscope™ System for Detection and Molecular Analysis of Circulating Tumor Cells
    October 8, 2010

    Hayward, CA — October 8, 2010 — Advanced Cell Diagnostics, Inc. (ACD) was awarded a three-year, $3 million grant from National Cancer Institute (NCI) under its SBIR Phase II Bridge Award. This grant will support ACD’s continuing effort to develop its proprietary CTCscope™ system capable of automatic detection and molecular characterization of circulating tumor cells (CTCs). CTCs are the rare tumor cells detached from solid tumors and circulating in cancer patients’ blood.

    “We are very grateful for the continued support from NCI. The previous Phase I and Phase II grants have helped ACD to develop the underlying RNAscope™ technology, which has since been translated successfully into Research Use Only products for in situ detection of RNA biomarkers in FFPE samples.” commented by Dr. Yuling Luo, President & CEO of ACD, “Given how few of these grants are given, the award is a further validation of the strength of our technology to uniquely fulfill a critical unmet clinical need in cancer management.” ACD has since been featured as one of the NCI SBIR Success Stories (http://sbir.cancer.gov/success/stories/acd/acd.asp).

    In this latest grant, ACD will work with a multidisciplinary team from four leading institutions to further advance CTCscope® into an automated system and conduct clinical studies to demonstrate its clinical utility. Collaborators include Dr. Paul Goodwin of Applied Precision, Drs. Hope Rugo and John Park of University of California San Francisco, Prof. David Krag of University of Vermont, and Prof. Charles Coombes of Imperial College London.

    About CTCscope™:

    ACD’s CTCscope™ system is based on its proprietary in situ RNA detection platform RNAscope™, which enables highly sensitive and specific detection of all types of CTCs without the need for EpCAM-based enrichment. Importantly, CTCscope™ is the only technology that detects those CTCs still alive while circulating in cancer patients’ blood. These are the rare tumor cells that have the potential to metastasize to distant sites and thus are the targets of chemo- and targeted therapies. CTCscope™ identifies the molecular phenotypes of CTCs for guiding treatment decisions and allows real-time monitoring of therapy response.

    About Advanced Cell Diagnostics

    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology, developing cell- and tissue- based diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first multiplex fluorescent and chromogenic in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single molecule sensitivity. ACD partners with pharmaceutical and biotechnology companies to validate biomarkers for targeted therapeutic development in cancer and other diseases. These partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop proprietary diagnostic tests in cancer management.

    Press Contacts

    Advanced Cell Diagnostics Steve Chen

    (510) 576-8800 x102

    schen@acdbio.com

  • ACD Launches RNAscope FFPE Assay Kit, a Breakthrough RNA in Situ Hybridization Product for Clinical Research and Biomarker Validation
    August 10, 2010

    Hayward, CA — August 10, 2010 — Advanced Cell Diagnostics, Inc. (ACD), announces the launch and immediate availability of RNAscope® FFPE Assay Kit, a line of RUO (Research-Use-Only) products designed to detect RNA biomarkers in routine Formalin-Fixed, Paraffin-Embedded (FFPE) tissue specimens with single molecule sensitivity.

    The products are intended to be used by translational clinical researchers studying biomarkers in disease tissues and exploring their potential for diagnostic applications. It is a robust and standardized manual assay in ready-to-use format that can be completed in approximately 6 hours. It does not require any expensive instrument and the staining results are archivable and can be visualized and interpreted under a bright field microscope. Unlike the earlier version of the assay, this clinical-grade assay can be transitioned seamlessly from translational research into clinical diagnostics. “Over the last several decades, IHC and FISH technologies have been developed to detect proteins and DNA in situ, respectively. But reliable detection of RNA in situ remains difficult, especially in routine clinical specimens,” said Dr. Yuling Luo, Founder, President and CEO of ACD. “The scientific community has finally got an ‘IHC-like’ tool for RNA that has the sensitivity and specificity rivaling that of PCR.”

    In a blind test in collaboration with a leading pharmaceutical company, the RNAscope® FFPE assay demonstrated PCR-level sensitivity and specificity, detecting an RNA biomarker in all samples deemed positive by real time RT-PCR but not in samples deemed negative. In contrast, using a traditional non-isotopic ISH, the collaborator detected the biomarker only in the highest expressing sample. Since the PCR-positive samples showed two orders of magnitude difference in expression levels, RNAscope® is as much as 100-fold more sensitive than the traditional non-isotopic ISH method.

    In addition to its RUO line of products, ACD is developing fully automated, proprietary diagnostic tests for personalized cancer treatment. The company is also partnering with pharmaceutical and biotechnology companies to leverage its RNAscope® platform for companion diagnostic applications.

    About Advanced Cell Diagnostics

    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology, developing cell- and tissue- based diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first multiplex fluorescent and chromogenic in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single molecule sensitivity. ACD partners with pharmaceutical and biotechnology companies to validate biomarkers for targeted therapeutic development in cancer and other diseases. These partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop proprietary diagnostic tests in cancer management.

  • ACD Completes the Second Closing of Series A Financing and Initiates Services for Biomarker Validation and Companion Diagnostic Development
    September 2, 2009

    Hayward, CA — September 2, 2009 — Advanced Cell Diagnostics, Inc. (ACD), announced today that it has completed the second closing of its Series A equity financing from Morningside Ventures, bringing the total capital raised in this round to $5.4 million. ACD will use the funds to accelerate the development of its proprietary diagnostic tests based on the company’s patent pending RNAscope® technology. “This second closing marks the achievement of our RNAscope® technology development milestones, including in situ detection of single RNA molecules in blood and FFPE tissues, multiplex analysis, and full assay automation.” said Dr. Yuling Luo, Founder, President and CEO of ACD, “We can now offer our world class assay development expertise in RNA analysis for biomarker validation and companion diagnostic development in partnership with pharmaceutical and biotechnology companies.”

    “We are pleased to be in partnership with ACD and are excited about the tremendous potential of RNAscope® technology. ACD has made impressive and speedy progress in RNAscope® technology development, achieving all of its milestones,” commented Morningside co-founder, Dr. Gerald Chan. “RNAscope® technology has great promise to shorten the path to targeted therapeutic development, hastening fulfillment of the vision of personalized medicine.”

    About Advanced Cell Diagnostics

    Advanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology, developing cell- and tissue-based diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first multiplex fluorescent and chromogenic in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single molecule sensitivity. ACD partners with pharmaceutical and biotechnology companies to validate biomarkers for targeted therapeutic development in cancer and other diseases. These partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop proprietary diagnostic tests in cancer management.

    About Morningside

    Morningside is a diversified investment group founded in 1986 by the Chan family of Hong Kong. It is engaged primarily in private equity and venture capital investments. The group has investments in North America, Europe, across Asia-Pacific, and since 1992, in Mainland China. Morningside was one of the earliest institutional investors in China's internet industry and in recent years has been an active investor in China's emerging biotechnology sector.

  • USCAP 2016 Annual Meeting Booth 724
    March 13, 2016 to March 16, 2016 / Seattle, WA

    105th United States & Canadian Academy of Pathology Annual Meeting

    Will be hosted at the WSCC - Washington State Convention Center, Seattle, USA

    Please join us at booth 724, open Sunday March 13 through Wednesday March 16, 2016. 

  • BioResearch Product Faire™ Event | BioResearch
    October 1, 2015 / Stony Brook University
  • BioResearch Product Faire™ Event
    September 30, 2015 / Rockefeller University
  • BioResearch Product Faire™ Event
    September 29, 2015 / The Armory Track & Field Center
  • The European Cancer Congress 2015 ECC2015
    September 25, 2015 / Messe Wien Exhibition & Congress Centre Messeplatz 1 1021 Vienna, Austria

    The recognized multidisciplinary setting of the European Cancer Congress will once again provide ideal surroundings for participants to leverage knowledge, promote education and build awareness about oncology - placing the patient at the heart of all our efforts and discussions. The Congress strives to further the role of multidisciplinary oncology by encouraging participation and interaction between all oncology professions, irrespective of their focus.

     

    www.europeancancercongress.org

  • NIH Research Festival Exhibit - NIH
    September 16, 2015 to September 17, 2015 / Bethesda, MD
  • Merck Single Use Manufacturing Symposium - MSUMS
    September 15, 2015 to September 16, 2015 / Blue Bell, PA
  • ISSCR 2015 Annual Meeting - ISSCR 2015
    June 24, 2015 to June 27, 2015 / Stockholmsmässan Exhibition and Convention Center, Mässvägen 1, Älvsjö, Sweden

    ISSCR 2015 Annual Meeting | ISSCR 2015

    June 24 - June 27, 2015 | Stockholmsmässan Exhibition and Convention Center, Mässvägen 1, Älvsjö, Sweden |

     

    The ISSCR is the premier international society for stem cell science, an organization dedicated to a concerted international approach to advancing research towards new therapies.

    The ISSCR Annual Meeting provides an opportunity for scientists, clinicians, educators and industry professionals to share new data, learn from peers, and discover global advances within the stem cell field. With approximately 3000 professionals from 55 countries, the ISSCR 2015 Annual Meeting is the global source of the discoveries that are the basis for treatments of tomorrow. 

  • BioResearch Product Faire™ Event - BioResearch
    June 11, 2015 / University of Massachusetts, Amherst
  • MAD SSCi & SEASR 2015 Joint Meeting - MAD SSCi & SEASR
    June 3, 2015 to June 5, 2015 / University of Virginia, Charlottesville
  • Merk Technology Symposium - MTS
    June 3, 2015 / DoubleTree Hotel and Garden State Exhibit Center, omerset, NJ
  • 2015 NIH Spring Biomedical Research Equipment & Supplies Exhibit | NIH
    May 22, 2015 / National Institutes of Health, Bethesda, MD
  • Advancing Drug Discovery through Genome Engineering - BRC
    May 21, 2015 / Merck Research Laboratories, 33 Avenue Louis Pasteur, Boston, MA
  • Florida Society of Histotechnology - FSH
    May 15, 2015 to May 18, 2015 / Hyatt Regency, New Orleans
  • VWR-Regeneron Spring Show - VWR
    May 15, 2015 / Regeneron Pharmaceuticals, Tarrytown, NY
  • BioResearch Product Faire™ Event - BioResearch
    May 14, 2015 / Duke University
  • American Society of Gene and Cell Therapy - ASGCT
    May 14, 2015 to May 17, 2015 / 27-story Buena Vista Palace Hotel & Spa, Lake Buena Vista
  • ACD & BIOKÉ User Seminar - THE RNA REVOLUTION - EU User Seminar
    May 13, 2015 / Regardz Meeting Center "Zilveren Toren" in Amsterdam, AH Stationsplein 51, 1012 AB Amsterdam, The Netherlands

    ACD & BIOKÉ User Seminar - THE RNA REVOLUTION | EU User Seminar

    May 13 - May 13, 2015 | Regardz Meeting Center "Zilveren Toren" in Amsterdam, AH Stationsplein 51, 1012 AB Amsterdam, The Netherlands |

     

    THE RNA REVOLUTION

    Elevate your research using gene expression analysis combined with spatial resolution

    May 13, 2015 - 14.00 to 16.30 

    Location: Regardz Meeting Center "Zilveren Toren" in Amsterdam (next to the Central Station)
    AH Stationsplein 51, 1012 AB Amsterdam, The Netherlands

    During the seminar you will see how RNAscope helps:

    • Assessing intra-tumor heterogeneity, microenvironment (TME) & cancer stem cells expression
    • Characterize stem cells function and their signaling role in diseases
    • As a surrogate for antibodies (low abundance targets, secreted proteins, novel targets or non coding RNAs)
    • Assessing the tissue context of genomic based discoveries
    • To detect and locate multiple markers within FFPE at the same time

    AGENDA

    14.00 - 14.30
    Yuling Luo Ph.D. - Founder, President & Chief Executive Officer at Advanced Cell Diagnostics, Hayward (US)
    "The Renaissance of ISH - Development of next generation in situ hybridization technologies for research and diagnostics"
     
    14.30 - 14.50
    Auke Verhaar M.Sc. - Ph.D. student in the department of Gastroenterology and Hepatology, Erasmus MC, Rotterdam (NL)
    "Localizing HoxA13 expression using RNAscope"
     
    15.05 - 15.40 
    Oliver von Ahsen Ph.D. - Bayer Pharma AG, Berlin (D)
    “RNAscope in biomarker research: From specificity control to patient selection in clinical studies”
     
    15.40 - 16.00 
    Mathias Holpert Ph.D. - European Field Application Specialist at Advanced Cell Diagnostics (D)
    Tips & Tricks: "How to apply the RNAscope assay to your target and sample type - optimization, examples and technical tips"

    After the presentations, you are invited to join us for a drink and a bite. 

    REGISTER HERE

  • BMS R&D Symposium - BMS
    May 12, 2015 to May 13, 2015 / Doubletree Hotel and Garden State Exhibit Center - Somerset, NJ
  • BioResearch Product Faire™ Event - BioResearch
    May 8, 2015 to May 9, 2015 / Rutgers University, Piscataway
  • BioResearch Product Faire™ Event | BioResearch
    May 8, 2015 / The University of Pennsylvania
  • Applications of In Situ Hybridisation in Research and Disease
    May 7, 2015 to May 8, 2015 / Cancer Research UK Cambridge Institute, University of Cambridge Li Ka Shing Centre, Robinson Way Cambridge CB2 0RE, UK | Li Ka Shing Centre

    Applications of In Situ Hybridisation in Research and Disease | Applications of In Situ Hybridisation in Research and Disease

    May 07 - May 08, 2015 | Cancer Research UK Cambridge Institute, University of Cambridge Li Ka Shing Centre, Robinson Way Cambridge CB2 0RE, UK | Li Ka Shing Centre

     

    Cancer Research UK Cambridge Institute, University of Cambridge
    Li Ka Shing Centre, Robinson Way
    Cambridge CB2 0RE, UK

    This conference will discuss the application of in situ hybridisation across a variety of themes:

    • Chromogenic and Fluorescent in situ hybridisation. Chair: Dr J Howard Pringle (University of Leicester)
    • Automation of in situ hybridisation. Chair: Dr Julia Jones (University of Cambridge)
    • Single Molecule Detection in situ hybridisation. Chair: Professor Scott Fraser (University of Southern California)
    • Non-coding RNA in situ hybridisation. Chair: Dr Boye Schnack Nielsen (Bioneer A/S)

    http://www.cruk.cam.ac.uk/seminars-conferences/ish_symposium

  • BioResearch Product Faire™ Event - BioResearch
    May 7, 2015 / Thomas Jefferson University
  • BioResearch Product Faire™ Front Line™ Event - BioResearch
    May 5, 2015 / The University of Maryland, Baltimore
  • American Association for Cancer Research Annual Meeting 2015 | AACR 2015
    April 19, 2015 to April 22, 2015 / Pennsylvania Convention Center, Booth 1939, Philadelphia, PA
  • ACD SYMPOSIUM The RNA Revolution - ACD Symposium
    April 7, 2015 / Hyatt Regency Cambridge,Cambridge MA

    ACD SYMPOSIUM The RNA Revolution | ACD Symposium

    April 07 - April 07, 2015 | Cambridge MA | Hyatt Regency Cambridge, MA

     

    RNA expression reflects the state of a biological system, it presents an ideal choice of biomarker and has become a significant focus for research, diagnostic and pharmaceutical arenas.  In order to utilize the full potential of these biomarkers, there is an unprecedented demand for the next generation of more effective tools for routine RNA biomarker analysis. This demand is particularly acute when it comes to in situ techniques, in order to map important pathways and networks within the morphological context.

    This symposium features discussions by scientists who have successful applied RNA ISH in drug and CDx development and clinical research. Presenters will share how their work has been impacted by a new dimension of information—gene expression with spatial resolution. They will also discuss how RNA ISH complements IHC and will present data obtained with automation system from Leica and Ventana.

    We invite scientists from Pharmas, Biotechs and Academic labs who are applying molecular methods in disease research and interested in elevating their research with new RNA analysis technologies.

  • US & Canadian Academy of Pathology Annual Meeting 2015 | USCAP 2015
    March 23, 2015 to March 25, 2015 / Hynes Convention Center, Booth 301, Boston, MA
  • US & Canadian Academy of Pathology Annual Meeting 2015 | USCAP 2015
    March 23, 2015 to March 25, 2015 / Hynes Convention Center, Booth 301, Boston, MA

    All Day

  • Whole-Mount Zebrafish Embryos - RNAscope® for High-Resolution Detection of Transcripts with Localization of Proteins
    Azadeh Paksa & Theresa Gross-Thebing from Prof. Dr. Erez Raz's lab,
    Abstract:

    Abstract:
    Whole-mount in situ hybridization (WISH) is a fundamental tool used for studying the spatio-temporal expression pattern of RNA molecules in intact embryos and tissues. The available methodologies for detecting mRNAs in embryos rely on enzymatic activities and chemical reactions that generate diffusible products, which are not fixed to the detected RNA, thereby reducing the spatial resolution of the technique. In addition, current WISH techniques are time-consuming and are usually not combined with methods reporting on the expression of protein molecules.

    The protocol we present here is based on RNAscope® Technology allowing a robust and rapid method for visualization of multiple transcripts in zebrabfish embryos. 

    PRESENTER: 
    Azadeh Paksa & Theresa Gross-Thebing from Prof. Dr. Erez Raz's lab
    Institute of Cell Biology - Center for Molecular Biology of Inflammation
    Münster, Germany

    Publications to be discussed:

    Simultaneous high-resolution detection of multiple transcripts combined with localization of proteins in whole-mount embryos
    Gross-Thebing T, Paksa A, Raz E.
    BMC Biol. 2014 Aug 15;12(1):55.
    PMID: 25124741

    Attendees will learn:

    Attendees will learn:
    - How RNAscope® is used for the visualization of multiple transcripts demonstrated for three different RNA molecules in the 3-dimensional context of the developing embryo
    - How to optimize the procedure allowing the preservation of embryo integrity, while exhibiting excellent signal-to-noise ratios
    - How this method preserves the function of fluorescent proteins that are expressed in specific cells or cellular organelles and conserves antigenicity
    - Which advantages RNAscope® offers compared to conventional in situ hybridization techniques

  • Steps for Success with RNAscope® Assay and New Product Development
    Sudha Krishnan, Technical Support Specialist, Advanced Cell Diagnostics
    Abstract:

    This RNAscope® Training webinar will help new or recent users understand the RNAscope® technology and discuss how to produce quality results with simple and easy steps. The webinar will provide tips and tricks to perform RNAscope® assay successfully in your lab. We will also discuss and review the recent RNAscope® assay 2.5 product developments. You will learn about manual assay improvements with regards to product sensitivity, ease-of use and robustness.

    Who should attend:
    • New and recent RNAscope® assay users
    • Traditional ISH users new to RNAscope®
    • IHC users interested in RNA ISH for complementary studies
    • RNAscope® automation users needing a refresher course
    Attendees will learn:
    • How RNAscope® technology works?
    • Tips for getting started
    • Tools for success
    • New developments in RNAscope® manual assay. 
  • PTEN mRNA detection by chromogenic RNA in-situ technologies: A reliable alternative to PTEN Immunohistochemistry
    Stephen McQuaid , Clinical Scientist Northern Ireland Molecular Pathology Laboratory
    Professor Manuel Salto-Tellez, Chair of Molecular Pathology and Clinical Consultant Pathologist Northern Ireland Molecular Pathology Laboratory, Centre for Cancer Research and Cell Biology, QUB, Belfast.
    Abstract:

    Immunohistochemical staining for Phosphatase and Tensin Homolog (PTEN) does not have either an acceptable standard protocol or concordance of scoring between pathologists. Evaluation of PTEN mRNA with a unique and verified sequence probe may offer a realistic alternative providing a robust and reproducible protocol. In this study we have evaluated an in-situ hybridization (ISH) protocol for PTEN mRNA using RNAscope® technology and compared it with a standard protocol for PTEN immunohistochemistry (IHC). mRNA detection of PTEN or other biomarkers, for which optimal or standardized immunohistochemical techniques are not available, represents a means by which heterogeneity of expression within focal regions of tumour can be explored with more confidence.

     

    Watch the webinar here

    Attendees will learn:

    1. How the PTEN expression profile in various cancer types can be used as a prognostic marker.

    2. How the detection of PTEN mRNA expression in tissue sections preserving the morphological context, and therefore the heterogeneity of expression within focal regions of various tumour types, can be explored.

    3. Why RNAscope® in-situ hybridization (ISH) is a good alternative for the detection of biomarkers, such as PTEN, when there is no optimal or standardized immunohistochemical techniques available.

  • RNAscope® New Product Development - learn about RNAscope 2.5 product line
    Vanee Pho, Senior Product Manager
    Abstract:

    This RNAscope® Webinar will review innovative product developments with the RNAscope® assay platform. You will learn about manual and automated assay improvements with regards to product sensitivity, ease-of use and robustness.  

  • Dec 17th, 2015 - Steps for Success with RNAscope® Assay and New Product Development
    Morgane Rouault, Technical Support Scientist, Advanced Cell Diagnostics Europe
    Daniel Kim, Field Application Specialist, Advanced Cell Diagnostics
    Abstract:

    Join the ACD team for our new training webinar series to perform RNAscope® Assay successfully in your lab and obtain publication quality RNA in situ images. 

    This RNAscope® Training webinar will help new or recent users understand the RNAscope® technology and discuss how to produce quality results with simple and easy steps. The webinar will provide tips and tricks to perform RNAscope® assay successfully in your lab. We will also discuss and review the recent RNAscope® assay 2.5 product developments. You will learn about manual assay improvements with regards to product sensitivity, ease-of use and robustness.

    Who should attend:
    • New and recent RNAscope® assay users
    • Traditional ISH users new to RNAscope®
    • IHC users interested in RNA ISH for complementary studies
    • RNAscope® automation users needing a refresher course
    Attendees will learn:
    • How RNAscope® technology works?
    • Tips for getting started
    • Tools for success
    • New developments in RNAscope® manual assay. 
  • Steps for success with RNAscope Assay: Basic Training for New Users
    Jacqueline Akech, PhD.,, Sr. Scientist, Advanced Cell Diagnostics
    Abstract:

    This RNAscope® Training will help new or recent users understand the RNAscope® technology and discuss how to produce quality results with simple and easy steps. The webinar will provide tips and tricks to perform RNAscope® successfully in your lab. By understanding RNAscope® assay basics, users will feel confident about performing the assay and will be able to obtain publication quality RNA in situ images.

    Who should attend:
    • New and recent RNAscope® manual assay users
    • Traditional ISH users new to RNAscope®
    • IHC users new to RNAscope®
    • RNAscope® users needing a refresher course
    Attendees will learn:
    • How RNAscope® technology works?
    • Tips for getting started
    • Tools for success
  • Visualization of exogenous RNA using RNAscope ISH in rat brain to assess viral vector transduction
    Nicole Polinski, PhD Student & Caryl Sortwell Professor
    Abstract:

    The recognized multidisciplinary setting of the European Cancer Congress will once again provide ideal surroundings for participants to leverage knowledge, promote education and build awareness about oncology - placing the patient at the heart of all our efforts and discussions. The Congress strives to further the role of multidisciplinary oncology by encouraging participation and interaction between all oncology professions, irrespective of their focus. www.europeancancercongress.org

    Download Presentation

  • Elucidating tumor heterogeneity in prostate cancer by combined IHC & novel RNA ISH
    Nallasivam Palanisamy, PhD | Associate Scientist, Department of Urology Henry Ford Health System, Detroit, MI
    Abstract:

    Assessment of molecular heterogeneity in tumor is a challenging task. It is for the first time Palanisamy et al have demonstrated the existence of rare subset of prostate cancer with heterogeneous molecular aberrations involving ETS family genes and SPINK1 expression utilizing both standard immunohistochemistry (IHC) and RNA in situ hybridization (Advanced Cell Diagnostics RNAscope® Technology). The presenter will discuss the application of RNA ISH technology to reveal hitherto unidentified molecular subtypes of prostate cancer.

    Publications to be discussed:

    1. Kunju LP, Carskadon S, Siddiqui J, Tomlins SA, Chinnaiyan AM, Palanisamy N.(2014) Novel RNA hybridization method for the in situ detection of ETV1, ETV4, and ETV5 gene fusions in prostate cancer. Appl Immunohistochem Mol Morphol. 2014 Sep;22(8):e32-40. doi: 10.1097/PAI.0000000000000095.

    2. Joshua I Warrick, Scott A Tomlins, Shannon L Carskadon, Allison M Young,Javed Siddiqui, John T Wei, Arul M Chinnaiyan, Lakshmi P Kunju, and Nallasivam Palanisamy Evaluation of tissue PCA3 expression in prostate cancer by RNA in situ hybridization— a correlative study with urine PCA3 and TMPRSS2-ERG Modern Pathology (2014) 27, 609–620

    Who should attend:

    Cancer researchers, pathologists, histologists interested in understanding new molecular techniques to:

    • Uncover intra-tumoral heterogeneity
    • Understand how measuring RNA expression can uncover details of tumor microenvironments
    • Understand cell-specific expression information
    • Visualize RNA targets in the full context of tissue architecture and/or measure regional RNA distribution
    • Quantify expression of coding and non-coding RNA including pseudogenes
    Attendees will learn:
    • How RNAscope Technology can be used in cancer research
    • How RNAscope Technology delivers quantitative molecular detection and morphological context in a single assay
    • Ease of using the highly sensitive and specific assay for virtually any gene in any tissue
    • Advantages of RNAscope Technology versus other ISH and IHC methods

    Download Presentation

  • RNAscope® Technology: A Novel RNA In Situ Hybridization Research Platform
    Chris Bunker, Ph.D., VP Business Development, Advanced Cell Diagnostics
    Abstract:

    RNAscope® Technology is a cutting-edge in situ hybridization (ISH) technology based on Advanced Cell Diagnostics (ACD) unique, patented probe design strategy that enables simultaneous signal amplification and background noise suppression. RNAscope Technology represents one of the most significant advances in ISH technology in over 40 years.
     

    Who should attend:

    Principle Scientists, Group Leaders, Head of Biology/Research, Pharmacologists and Pathologists who:
    • Need to understand cell-specific expression information
    • Want to directly visualize RNA targets in the full context of tissue architecture and/or measure regional RNA distribution
    • Want to study intra-tumoral heterogeneity
    • Need to select and validate targets for drug development

    Attendees will learn:
    • How RNAscope delivers quantitative molecular detection and morphological context in a single assay
    • Ease of using the highly sensitive and specific assay for virtually any gene in any tissue
    • Advantages of RNAscope Technology versus other ISH and IHC methods             
    • How RNAscope can be used for rapid target validation and translational research
  • Linking Viral Discovery with Causality
    Patricia Pesavento, DVM, PhD, DIP ACVP. Professor of Pathology, Microbiology & Immunology School of Veterinary Medicine, University of California, Davis
    Abstract:

    The majority of emerging diseases are infections with viruses that jump species barriers from wildlife or domestic animals to humans. The advent of molecular methods like high-throughput sequencing dramatically scaled viral discovery in humans and animals. Efficient and (nearly) unbiased discovery has expanded our understanding of the complexity of viral families, can inform individualized medicine, can quickly identify emerging disease, and even potentially can anticipate emergence. Many of these novel viruses are innocuous, so along with powerful discovery tools comes a responsibility in the medical research community to uncover viral pathogenesis and to clearly define associations, if present, with disease.

    Our laboratory has discovered novel viruses in multiple animal species, and utilizes a combination of tools, including RNAscope® in situ hybridization, to disentangle the complex host-pathogen interactions. In this presentation, we will consider the evidence for disease causality using novel persistent (papillomavirus), oncogenic (polyomavirus, circovirus), and acute cytolytic (astrovirus) viruses as examples. These studies have expanded our understanding of how and when viruses potentially cause disease, and demonstrate the impact and relevance of natural disease. Expanded consideration of the health of all animals is a balanced approach to world health.

    Publications to be discussed:

    Divergent astrovirus associated with neurologic disease in cattle. Li L., et al. (2013). Emerg. Infect. Dis.;19(9):1385-92.

    Interview with Dr Patricia Pesavento

    Neurotropic astrovirus in cattle with nonsuppurative encephalitis in Europe.  Bouzalas I.G., et al. (2014). J. Clin. Microbiol.;52(9):3318-24. 

    Astrovirus VA1/HMO-C: an increasingly recognized neurotropic pathogen in immunocompromised patients. Brown J.R. et al. (2015). Clin Infect Dis.;60(6):881-8. 

    Diagnosis of neuroinvasive astrovirus infection in an immunocompromised adult with encephalitis by unbiased next-generation sequencing. Naccache S.N., et al. (2015). Clin. Infect. Dis.;60(6):919-23.
       
    Merkel cell carcinoma: a virus-induced human cancer. Chang Y. & Moore P.S. (2012).  Annu. Rev. Pathol.;7:123-44.  
     
    Novel polyomavirus associated with brain tumors in free-ranging raccoons, western United States. Dela Cruz F.N,.et al. (2013). Emerg. Infect. Dis.;19(1):77-84.

  • ACD & BIOKÉ User Seminar in Amsterdam
    THE RNA REVOLUTION
    May 13 2015 - 14.00 to 16.30

    Elevate your research using gene expression analysis combined with spatial resolution

    Location: Regardz Meeting Center "Zilveren Toren" in Amsterdam (next to the Central Station), AH Stationsplein 51, 1012 AB Amsterdam, The Netherlands

    During the seminar you will see how RNAscope helps:

    • Assessing intra-tumor heterogeneity, microenvironment (TME) & cancer stem cells expression
    • Characterize stem cells function and their signaling role in diseases
    • As a surrogate for antibodies (low abundance targets, secreted proteins, novel targets or non coding RNAs)
    • Assessing the tissue context of genomic based discoveries
    • To detect and locate multiple markers within FFPE at the same time

    Register Here

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