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TrimGen Gets FDA OK for Warfarin Genotyping Test

NEW YORK (GenomeWeb News) – TrimGen has received US Food and Drug Administration 510(k) clearance for its eQ-PCR Warfarin Genotyping kit, the Sparks, Md.-based firm said today.

The TrimGen kit tests for SNPs in the VKORC1 and cytochrome P450 CYP2C9 genes, which serve as clinically relevant predictors of warfarin dosing. The assay is used aid physicians in identifying patients who may be at risk of warfarin sensitivity.

TrimGen is one of several firms over the past year and a half to receive FDA clearance for a warfarin sensitivity test, following Nanosphere, Autogenomics, ParagonDx, and Osmetech.

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