AutoGenomics’ Warfarin Test Wins FDA OK; Gauges Variants Competitors Don’t | GenomeWeb
AutoGenomics last week announced that the US Food and Drug Administration has approved its Infiniti Warfarin XP dose-response assay for identifying patients with CYP450 2C9 and VKORC1 genetic variants.
AutoGenomics, based in Carlsbad, Calif., submitted the assay to the FDA for 510(k) approval last December. The test runs on the company’s Infiniti platform, which the FDA cleared for multiplex testing earlier this year.

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