TrimGen Seeks FDA Clearance for Warfarin PGx Kit

Dec 07, 2007

NEW YORK (GenomeWeb News) – Molecular diagnostics firm TrimGen said today that it has filed with the US Food and Drug Administration for 510(k) clearance of its diagnostic kit to aid physicians in prescribing the anticoagulant warfarin.

The firm’s eQ-PCR LightCycler Warfarin Genotyping Kit identifies certain SNPs in the CYP2C9 and VKORC1 genes, which serve as clinically relevant predictors of warfarin dosing. The test is run on Roche’s LightCycler platform.

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