Wednesday, September 19, 2007

 

warfarin

Genetic Test for Warfarin Sensitivity Cleared for Marketing

The FDA has cleared for marketing a genetic test to gauge a patient's sensitivity to the anticoagulant warfarin (Coumadin).

The Verigene warfarin metabolism test, manufactured by Nanosphere, detects variants of two genes, CYP2C9 and VKORC1, which can contribute to changes in warfarin metabolism. The agency says that about one-third of patients on warfarin "metabolize it quite differently than expected and experience a higher risk of bleeding."

According to the FDA, "The Nanosphere test is not intended to be a stand-alone tool to determine optimum drug dosage, but should be used along with clinical evaluation and other tools, including INR, to determine the best treatment for patients."


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