Osmetech initiates clinical studies for new warfarin sensitivity test

Osmetech obtained clearance from the FDA in July 2008 for its eSensor warfarin sensitivity test to be used as an aid in the identification of patients at risk for increased sensitivity to the blood-thinning drug, warfarin.

The new extended warfarin test incorporates a number of additional markers, including the CYP450 4F2 biomarker exclusively-licensed from Marshfield Clinic, the company said.

Following successful preclinical studies, clinical trials will be conducted at three sites with the results supporting the company’s submission for 510(k) clearance to the FDA expected to be filed before the end of 2008.

James White, CEO of Osmetech, said: “We are excited by the prospects of being able to provide what we believe will be the most comprehensive FDA-cleared test for warfarin sensitivity available in the marketplace, which will include our important and unique biomarker, 4F2.”