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Diagnostics In Brief

This article was originally published in The Gray Sheet

Executive Summary

First genetic test for warfarin sensitivity cleared: Nanosphere's Verigene multiplex nucleic acid test for genetic variations that influence metabolism of the common blood-thinner warfarin is 510(k)-cleared Sept. 17. FDA updated the labeling of warfarin in August to explain that patients with variations in the CYP2C9 and VKORC1 genes may respond differently to the drug (1"The Gray Sheet" Aug. 20, 2007, p. 9). Other firms developing warfarin test kits include AutoGenomics, Nanogen, Third Wave Technologies and Luminex
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