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ParagonDx Gets FDA OK for Warfarin Kit

NEW YORK (GenomeWeb News) – ParagonDx said today that it has received US Food and Drug Administration clearance to market its rapid genotyping assay for warfarin sensitivity.
The pharmacogenomic test provides information about the CYP2C9 and VKORC1 genotypes and is used to identify patients that are at greater risk for warfarin sensitivity. ParagonDx claimed in a statement that its product is the first cleared genotyping assay to deliver results in less than an hour and incorporate human genomic quality controls.
The firm’s kit joins warfarin assays from Nanosphere and Autogenomics that have already received FDA clearance.
ParagonDx President and CEO Michael Murphy said that including quality controls “will provide the kind of assurance that laboratories need to ensure accuracy and reliability.”
The Morrisville, NC-based firm said that its assay was cleared by FDA using Cepheid’s SmartCycler Dx platform.