FDA Clears Osmetech’s New Warfarin Sensitivity Test
Osmeteche's Sensor Warfarin Sensitivity Test is a genetic test to identify patients at risk for increased sensitivity to the widely used blood-thinning drug, warfarin.
The eSensor Warfarin Sensitivity Test detects the three genetic markers that are known to play a critical role in metabolism of, and sensitivity to, warfarin. Through detection of these genetic markers, doctors are better able to accurately and efficiently determine the appropriate warfarin dosage level.
The company said its second-generation platform, the eSensor XT-8, is designed to support a broad menu of tests and provide accurate results while minimizing technician involvement.
The FDA 510(k) cleared the product in July 2008