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Osmetech Plans to Submit Warfarin Assay to FDA by Year End

NEW YORK (GenomeWeb News) - Osmetech today said it plans to submit an assay to predict individual response to the blood-thinning drug warfarin to the US Food and Drug Administration sometime late in 2007.
The company said it plans to launch the warfarin test, which will run on its eSensor XT-8 molecular diagnostic platform, in the first half of 2008.
Osmetech also said it recently took a license for Vitamin K Epoxide Reductase gene polymorphisms from the University of Washington. VKOR is a “key diagnostic marker for the management of warfarin dosage,” the company said.
The FDA announced yesterday that it will update warfarin’s label to include information about the genetic basis for response to warfarin.
“This development by the FDA confirms Osmetech is ideally placed to benefit in this rapidly growing sector," Osmetech CEO James White said in a statement.