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news.Osmetech has received 510(k) clearance from the FDA 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.
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The company has also announced that the FDA clearance includes its second generation eSensor XT-8 molecular diagnostics platform.
Osmetech’s eSensor warfarin sensitivity test detects the three genetic markers that are known to play a critical role in metabolism of, and sensitivity to, warfarin. The eSensor XT-8 is said to be designed to support a broad menu of tests and provide accurate results while minimizing technician involvement.
James White, CEO of Osmetech, said: “The FDA clearance is an important milestone for Osmetech. As we gear up the launch of our warfarin sensitivity test in the US this clearance provides further validation of our strategy of targeting the exciting opportunities in the rapidly developing molecular diagnostics market.”