Two US companies, Applied Biosystems and Asuragen, are collaborating with the Critical Path Institute’s Predictive Safety Testing Consortium (PSTC) to develop a gene signature panel that will allow pharmaceutical companies to screen potential therapies quickly and easily for toxic effects in preclinical samples.

Applied Biosystems develops and markets technology solutions for DNA, RNA, protein and small-molecule analysis, while Asuragen is a molecular biology services provider and diagnostic reagent company focused on oncology.

In the collaboration with the PSTC, Applied Biosystems assays will be used to “determine and differentiate” drug effects that are genotoxic from non-genotoxic modes of action as a contribution to risk assessment, the company explained.

PSTC researchers will have access to Applied Biosystems’ TaqMan Gene Signature Assays (a collection of RNA expression assays), together with real-time PCR (polymerase chain reaction) technology. The aim is to develop a biomarker panel for use in screening potential therapeutics for carcinogenic effects at the preclinical stage.

Asuragen is supplying “crucial laboratory services” as well as pharmacogenomics expertise and bioinformatics capabilities for the PSTC project, Applied Biosystems noted.

The PSTC is a public/private partnership between industry, academia and regulators, intended as a neutral body for co-ordinating activities related to biomarker qualification in drug development. It was set up by the non-profit Critical Path Institute two years ago, with the US Food and Drug Administration serving in an advisory capacity.

In establishing the consortium, eight leading pharmaceutical companies took the unprecedented step of agreeing to share preclinical laboratory data in order to improve the testing of medicines before they reached human clinical trials. The FDA has made biomarkers central to the Critical Path programme, launched in March 2004 with the goal of modernising and streamlining medical product development.

Last May, the FDA and the European Medicines Agency (EMEA) qualified the use of seven biomarkers for drug-induced renal toxicity in non-clinical drug development based on pooled data submitted by the PSTC.