AutoGenomics Files Infiniti Warfarin-Metabolism Assay With FDA for 510(k) Clearance

Dec 11, 2006

NEW YORK (GenomeWeb News) — AutoGenomics today said it has filed one of its Infiniti assays with the US Food and Drug Administration for 510(k) pre-market review.

AGI said it expects to receive 510(k) approval around the middle of 2007. Until that approval comes through, the company said, customers may use a self-validation process.

The assay is designed to spot genetic variants of an enzyme linked to the therapeutic use of the common anti-coagulant warfarin.

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