Key market for Tm Bioscience enhanced by new FDA guidelines

Draft FDA guidelines encourage drug developers to collect genetic test data

24-Nov-2003

TM Bioscience Corporation announced it anticipates recent FDA guidance to the pharma and biotech industries to include pharmacogenomic data as part of drug submissions will significantly drive market growth for specific genetic tests that Tm has launched and is developing. "We are excited that the FDA has provided guidance on how to present genetic test data collected as part of clinical trials," said Greg Hines, President and CEO of Tm Bioscience. "These new guidelines give regulatory legitimacy to DNA testing and represent a substantial opportunity for our line of P450 genetic tests targeting drug metabolism." The draft guidance by the FDA recommends that biotech and pharmaceutical companies submit human and animal pharmacogenomic data as part of routine submissions for investigational new drug applications (IND), new drug applications (NDA), and biological license applications (BLA). Pharmacogenomics is defined as the use of genetic testing in conjunction with drug therapy. Specifically, the FDA has highlighted genetic variations in cytochrome P450 enzymes as valid genetic markers of drug metabolism. The draft guidance will undergo a 90-day feedback period and is anticipated to be fully implemented by mid-2004. About Tag-It(TM) Drug Metabolism tests The product pipeline for Tm Bioscience currently includes three genetic tests targeting drug metabolism. The Tag-It(TM) P450-2D6 test was commercially launched in June 2003. It will be used to identify the presence or absence of important mutations common in patients with atypical drug metabolism, which can lead to adverse drug responses, the third leading cause of emergency room admissions in the United States. It is estimated that 20% of currently available prescription drugs are metabolized by P450-2D6 derived enzymes. Two of the largest American labs have signed supply agreements for this test, including Mayo Foundation in Rochester, Minnesota, which has signed a two-year purchase agreement. The Company's pre-commercial pipeline includes two additional drug Metabolism tests. The Tag-It(TM) Mutation Detection Kits for P450-2C9 and the Tag-It(TM) Mutation Detection Kits for P450-2C19 will test for mutations linked to atypical metabolism for a range of drugs under development. The Company anticipates that these tests will be commercially available in the first half of 2004. All of Tm Bioscience's genetic tests are based on the Tm Universal Array platform and operate on the Luminex xMAP(R) system. The Universal Array enables the production of highly accurate, high-throughput, low cost DNA-based tests.

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