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TrimGen Seeks FDA Clearance for Warfarin PGx Kit

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.
According to Sparks, Md.-based TrimGen, results of more than 5,000 tests during clinical trials showed 100 percent agreement between its warfarin kits and the corresponding bi-directional sequencing method.
Several firms sell home-brew molecular diagnostic ASRs for warfarin dosing, and many have said they would seek FDA clearance for their tests.
Thus far, Nanosphere is the only firm to receive FDA clearance of a test for warfarin sensitivity.
Nanosphere’s Verigene Warfarin Metabolism Nucleic Acid Test, which runs on the company’s Verigene platform, was cleared in September and also detects some variants of the CYP2C9 and VKORC1 genes.
In August, the FDA updated labeling for warfarin with information explaining that people with variations in CYP2C9 and VKORC1 may respond differently to the drug. The agency, however, stopped short of requiring physicians to genetically test their patients, noting that additional outcomes studies needed to be done.

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