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AutoGenomics Gets FDA OK for Warfarin MDx Assay

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.
Autogenomics received FDA clearance last May for its Infiniti Analyzer as a stand-alone instrument for multiplexed assays. The firm also holds FDA clearance for its Infiniti Factor II and Factor V assays for diagnosing thrombophilia.
In August, FDA updated labeling for warfarin with information explaining that people with variations of the genes CYP2C9 and VKORC1 may respond differently to the drug.
The agency, however, stopped short of requiring physicians in the label to genetically test their patients, noting that additional outcomes studies needed to be done.