NEW YORK (GenomeWeb News) – Applied Biosystems and Asuragen are collaborating with the Critical Path Institute’s Predictive Safety Testing Consortium to develop a predictive gene signature panel that pharmaceutical companies can use to screen pre-clinical therapeutics for toxicity, ABI announced today.
The Critical Path Institute, or C-Path, is a publicly funded non-profit research and education institute established in 2005 to help create and nurture industry, academic, and government collaborations that support the FDA’s 2004 Critical Path Initiative. Under the new collaboration, the institute plans to work with ABI and Asuragen to develop a panel of assays with gene targets associated with carcinogenicity in laboratory rats.
Researchers intend to develop a new biomarker panel based on ABI’s TaqMan Gene Signature Array and real-time PCR technology using ABI assays for risk assessment and determining and differentiating genotoxic and non-genotoxic modes of action for candidate drugs.
ABI will provide PSTC scientists with RNA expression assays, which the researchers plan to use to develop a biomarker panel that allows them to screen pre-clinical samples for carcinogenicity. Asuragen will contribute laboratory services, pharmacogenomic expertise, and bioinformatics capabilities to the PSTC project.
Drug toxicity is the leading cause of pre-clinical drug failures and costs the pharmaceutical industry billions of dollars each year. That, combined with calls from the US Food and Drug Administration and other regulatory bodies to bring better drugs to the market more quickly, has spurred efforts to come up with tools for avoiding drug toxicity.
C-Path established its PSTC as a means for bringing together pharmaceutical companies to improve drug safety and speed up their development. The PSTC currently has 16 members as well as scientists from the US Food and Drug Administration, the European Medicines Agency, and academic experts.