Applied Biosystems Inc. and Asuragen, Inc., a provider of pharmacogenomic services, are collaborating with the Critical Path Institute’s Predictive Safety Testing Consortium (PSTC) to develop a predictive gene signature panel that will allow pharmaceutical companies to screen potential therapeutics quickly and easily for toxic effects in pre-clinical samples.
The collaborators will use the Applied Biosystems assays to determine and differentiate effects that are genotoxic from non-genotoxic modes of action to assist in risk assessment. Applied Biosystems is providing its TaqMan Gene Signature Arrays, a collection of RNA expression assays, to be used by PSTC scientists, together with real-time PCR technology to develop a biomarker panel for use in screening potential therapeutics for carcinogenic effects in pre-clinical samples. Asuragen is contributing crucial laboratory services, pharmacogenomic expertise, and bioinformatics capabilities for the PSTC project.
The Critical Path Institute (C-Path) is a publicly funded institute, supporting collaborations that advance the FDA’s Critical Path Initiative, which is an endeavour to modernise the process for the development of medical products, including drugs, diagnostics and medical devices. The PSTC was established by C-Path to bring together major pharmaceutical companies to work in collaboration with C-Path and, in co-ordination with the FDA, to enable the exchange of knowledge and resources to speed drug development and improve drug safety.
C-Path was established in 2005 as a publicly funded, non-profit research and education institute to serve as ‘neutral ground’ and ‘trusted third party’ for collaborations between scientists and others from government, industry and academia. It has offices in Tucson, Arizona, and Rockville, Maryland.