FDA Clears Osmetech's Warfarin Sensitivity Test
Osmetech has received 510(k) clearance from the FDA for its eSensor Warfarin Sensitivity Test to be used to help identify patients with increased sensitivity to the blood-thinning drug warfarin.
Warfarin is the most prescribed oral anticoagulant in North America and Europe and is the second most likely drug, after Digoxin, to cause potentially life-threatening adverse events, according to Osmetech.
The test detects the three genetic markers that are known to play a critical role in metabolism of, and sensitivity to, warfarin. By detecting these genetic markers, doctors can determine an appropriate warfarin dosage level.