Osmetech Submits Warfarin Test for FDA Approval
Posted on: Monday, 7 January 2008, 09:00 CST
Osmetech has submitted eSensor 2C9/VKOR test to the FDA for 510(k) pre-marketing clearance. The test is to be used as an aid in the identification of patients at risk for increased sensitivity for the widely used blood-thinning drug, warfarin.
Clinical studies were performed at three evaluation sites in the US using the company's next generation eSensor XT-8 instrument. These followed the highly successful pre-clinical studies completed in November 2007 where 345 samples were tested using Osmetech's eSensor 2C9/VKOR method and found to be in 100% agreement with results from bi-directional DNA Sequencing.
James White, CEO of Osmetech, said: "We are delighted with the performance of our warfarin test and are confident of achieving FDA clearance to launch our warfarin test in the first half of 2008."
Source: Datamonitor
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