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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.
 
The company said it has finished a multi-center clinical study of how genetic variations within the enzyme CYP450 2C9/VKORC1 can affect a person’s ability to metabolize warfarin.
 
The company said it submitted the assay in October 2006.

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