AutoGenomics Gets FDA OK for Warfarin MDx Assay | GenomeWeb
NEW YORK (GenomeWeb News) – AutoGenomics today announced that it has received US Food and Drug Administration clearance to market its Infiniti 2C9-VKORC1 Multiplex Assay for warfarin sensitivity.
The Carlsbad, Calif.-based firm becomes the second firm to gain FDA clearance for a molecular-based assay for warfarin. In September, the agency approved Nanosphere’s Verigene Warfarin Metabolism Nucleic Acid Test, which runs on that company’s Verigene platform.

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