FOSTER CITY, Calif., Nov 06, 2008 (BUSINESS WIRE) — Drug toxicity accounts for billions of lost dollars to the pharmaceutical industry each year and is a leading cause of pre-clinical drug failures. The U.S. Food and Drug Administration (FDA) and other regulatory organizations have called upon the pharmaceutical industry to develop more effective tools to help avoid these costly failures, reduce the number of failed compounds, and bring better drugs to market sooner. To help address this challenge, Applied Biosystems Inc.
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and Asuragen, Inc., a provider of pharmacogenomic services, are collaborating with the Critical Path Institute’s Predictive Safety Testing Consortium to develop a predictive gene signature panel that will allow pharmaceutical companies to quickly and easily screen potential therapeutics for toxic effects in pre-clinical samples.
As part of the collaboration, Critical Path Institute (C-Path), Applied Biosystems, and Asuragen, Inc. will partner to develop a panel of assays with gene targets determined to be associated with carcinogenicity in laboratory rats, a common model organism for pharmaceutical testing. The collaborators will also use the Applied Biosystems assays to determine and differentiate effects that are genotoxic from non-genotoxic modes of action to assist in risk assessment. The new biomarker panel will be based on Applied Biosystems’ TaqMan(R) Gene Signature Array and real-time PCR technology.
C-Path is a publicly funded, nonprofit research and education institute. The institute was established in 2005 to create and support collaborations among industry, academic, and governmental scientists that advance the FDA’s Critical Path Initiative, which is an endeavor to modernize the process for the development of medical products, including drugs, diagnostics and medical devices. The Critical Path Opportunities List, published by the FDA in March 2006, presents examples of how new scientific discoveries in genomics and proteomics, imaging, and bioinformatics could be applied to improve the accuracy of the tests used to predict the safety and efficacy of investigational medical products.
“The development of robust turnkey assays to speed development of therapeutics for patients is one of the fundamental goals of the Critical Path Initiative, for which we believe we can make a difference working with partners such as Applied Biosystems and Asuragen,” said William B. Mattes, Ph.D., director of C-Path’s Predictive Safety Testing Consortium. “We expect this collaboration will facilitate broader utility of genomic biomarkers of toxicity across the industry in order to enable the early prediction and mechanistic understanding of potential carcinogens in pre-clinical research.”
The Predictive Safety Testing Consortium (PSTC) was established by C-Path to bring together major pharmaceutical companies to work in collaboration with C-Path and in coordination with the FDA. Its objective is to enable the exchange of knowledge and resources to speed drug development and improve drug safety. The Consortium currently has 16 members. Scientists from the FDA and its European counterpart, the European Medicines Agency, as well as academic experts also participate as advisors.
Increasingly, researchers are using Applied Biosystems comprehensive line of RNA analysis tools based on gold-standard TaqMan chemistry for the development of potential biomarkers. For this project, Applied Biosystems is providing PSTC scientists with its TaqMan Gene Signature Arrays. PSTC scientists will use this collection of RNA expression assays to develop a biomarker panel for use in screening potential therapeutics for carcinogenic effects in pre-clinical samples.
“Biomarkers that allow early prediction of toxicity will enable pharmaceutical companies to make better compound selection decisions and facilitate the early initiation of risk assessment work that would otherwise delay bringing important medicines to market,” said Peter Dansky, president of Applied Biosystems’ functional analysis division. “We are committed to continue expanding our menu of TaqMan Arrays for applications requiring a robust and highly-sensitive detection system in an easy-to-use and standardized format, such as in high-throughput drug screening.”
The development of tools that improve drug toxicity screening involves the generation and analysis of vast amounts of molecular data. Asuragen is contributing crucial laboratory services, pharmacogenomic expertise, and bioinformatics capabilities for the Predictive Safety Testing Consortium project.
“For this important project, Asuragen is committed to working with the Critical Path Institute and Applied Biosystems to help improve the drug development process,” said Matt Winkler, Ph.D., CEO and CSO of Asuragen.
About the Critical Path Institute
The Critical Path Institute (C-Path) was established in 2005 as a publicly funded, nonprofit research and education institute to serve as “neutral ground” and “trusted third party” for collaborations between scientists and others from government, industry and academia. C-Path’s mission is to help implement the FDA’s Critical Path Initiative (released in March 2004) by developing faster, safer and smarter pathways to new medical products. C-Path has offices in Tucson, Ariz. and Rockville, Md. For more information, visit
www.C-Path.org.
About Applied Biosystems Inc.
Applied Biosystems Inc. (formerly known as Applera Corporation) is a global leader in the development and marketing of instrument-based systems, consumables, software, and services for academic research, the life science industry and commercial markets. Driven by its employees’ belief in the power of science to improve the human condition, the company commercializes innovative technology solutions for DNA, RNA, protein and small molecule analysis. Customers across the disciplines of academic and clinical research, pharmaceutical research and manufacturing, forensic DNA analysis, and agricultural biotechnology use the company’s tools and services to accelerate scientific discovery, improve processes related to drug discovery and development, detect potentially pathogenic microorganisms, and identify individuals based on DNA sources. Applied Biosystems has a comprehensive service and field applications support team for a global installed base of high-performance genetic and protein analysis solutions. Applied Biosystems Inc. is headquartered in Norwalk, CT. On June 12, 2008, Applera Corporation and Invitrogen Corporation announced that their Boards of Directors had approved a definitive merger agreement under which Invitrogen will acquire all of the outstanding shares of Applied Biosystems stock. The merger is subject to customary closing conditions and is targeted to close in November 2008. Information about Applied Biosystems, including reports and other information filed by the company with the Securities and Exchange Commission, is available at http://www.appliedbiosystems.com. All information in this news release is as of the date of the release, and Applied Biosystems does not undertake any duty to update this information unless required by law.
About Asuragen, Inc.
Asuragen is a molecular biology service provider and fully integrated diagnostic reagent company focused on molecular oncology and the early detection of cancer, with emphasis on microRNA (miRNA). The Asuragen Pharmacogenomic Services Division provides comprehensive molecular services for DNA, mRNA, and miRNA empowering commercial and academic scientists to rapidly acquire a wide range of molecular data. Our services group possesses critical expertise in biomarker discovery, assay design and validation, clinical trial design, CLIA-based testing, project management, and analysis.
Asuragen also provides a high level of expertise in diagnostic assay development, a well developed business infrastructure, and an established cGMP manufacturing facility that allow it to span the spectrum of discovery, testing, production, and commercialization. Asuragen is dedicated to developing new technologies that will lead to cutting edge clinical products. Visit our website at www.asuragen.com
Applied Biosystems Forward Looking Statements
Certain statements in this press release are forward-looking. These may be identified by the use of forward-looking words or phrases such as “should,” “expect,” and “planned,” among others. These forward-looking statements are based on Applied Biosystems’ current expectations. The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for such forward-looking statements. In order to comply with the terms of the safe harbor, Applied Biosystems notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These factors include but are not limited to: (1) rapidly changing technology and dependence on the development and customer acceptance of new products; (2) sales dependent on customers’ spending policies; (3) other factors that might be described from time to time in Applied Biosystems’ filings with the Securities and Exchange Commission.
For Research Use Only. Not for use in diagnostic procedures. Practice of the patented 5′ Nuclease Process requires a license from Applied Biosystems. For further information on purchasing licenses contact the Director of Licensing, Applied Biosystems, 850 Lincoln Centre Drive, Foster City, California 94404, USA. The TaqMan(R) Array is covered by U.S. Patents Nos. 6,514,750 and 6,942,837. Micro Fluidic Card developed in collaboration with 3M Company.
(C)Copyright 2008. Applied Biosystems Inc. All rights reserved. Applied Biosystems, and AB (Design) are registered trademarks of Applied Biosystems Inc. or its subsidiaries in the U.S. and/or certain other countries. TaqMan is a registered trademark of Roche Molecular Systems, Inc. All other trademarks are trademarks of their respective owners.
SOURCE: Applied Biosystems Inc.
