Clinical Trials Commence for Extended Warfarin Sensitivity Test
News Nov 11, 2008
Osmetech plc announces that it has now commenced clinical trials for an extended warfarin sensitivity test.
Osmetech obtained clearance from the US Food and Drug Administration (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 widely used blood-thinning drug, warfarin.
The extended warfarin test incorporates a number of additional markers, including the CYP450 4F2 biomarker exclusively-licensed from Marshfield Clinic.
Following successful pre-clinical 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 as previously disclosed.
James White, Chief Executive, Osmetech plc, 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.”