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FDA Clears AutoGenomics' Thrombophilia Assay as IVD

NEW YORK (GenomeWeb News) — AutoGenomics today said its Infiniti Factor II and Factor V assays and automated instrumentation have received 510(k) clearance from the US Food and Drug Administration.
According to AutoGenomics, the assays may help diagnose the bleeding and clotting disorder thrombophilia.
The test is an in vitro diagnostic used on blood samples to detect DNA point mutations including Factor II Prothrombin G20210A and Factor V Leiden G1691A, the company said.
In December 2006 the company submitted to the FDA an assay for the enzyme CYP450 2C9/VKORC1 to help gauge warfarin dosing.