FDA Approves Genetic Lab Test for Warfarin Sensitivity

September 17, 2007 6:20 AM CT

The U.S. Food and Drug Administration approved a genetic test, the Nanosphere Verigene Warfarin Metabolism Nucleic Acid Test, that helps doctors identify whether a patient is especially sensitive to warfarin (Coumadin®).

One-third of patients receiving warfarin to prevent blood clots metabolize it differently than expected and have a higher risk of bleeding, some of which may be due to variants of two genes, CYP2C9 and VKORC1, which are detected by this test.

Warfarin is a very difficult drug, and according to the FDA is the second most common drug involved in emergency room visits for adverse drug events.

See FDA News Release: FDA Clears Genetic Lab Test for Warfarin Sensitivity