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FDA Clears Genetic Test for Warfarin Sensitivity

Nanosphere Verigene Warfarin Metabolism Nucleic Acid Test detects variants of two genes

THURSDAY, Sept. 20 (HealthDay News) -- The U.S. Food and Drug Administration has cleared a new genetic test for determining a patient's sensitivity to warfarin (Coumadin). The Nanosphere Verigene Warfarin Metabolism Nucleic Acid Test detects variants of two genes, CYP2C9 and VKORC1, which have been shown to account for some of the variation in response to the drug.

One-third of patients taking warfarin have a higher risk of bleeding due to differences in metabolizing the drug.

After insulin, warfarin is the second most common drug accounting for visits to the emergency department for adverse events, according to the FDA. A trial showed that the test was accurate in all cases where the test gave a result, while the test could not identify the genetic variants present in 8 percent of cases.

The test is manufactured by Nanosphere Inc. of Northbrook, Ill., and is cleared for use on the Verigene System.

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