ParagonDx Receives FDA 510(k) Marketing Clearance for Warfarin Sensitivity Genotyping Kit

Published: May 05, 2008

MORRISVILLE, N.C.--(BUSINESS WIRE)--ParagonDx, a leader in genetic testing diagnostics, has received 510(k) marketing clearance from the US Food and Drug Administration (FDA) for its in vitro diagnostic test. The Rapid Genotyping Assay is to be used to detect the presence of variations in the genes CYP2C9 and VKORC1. Information about the CYP2C9 and VKORC1 genotypes may be used as an aid in the identification of patients at greater risk for warfarin sensitivity. Warfarin, also known as Coumadin®, is a blood thinner that prevents and treats blood clots. ParagonDx’s genotyping assay is the first cleared product to deliver results in less than one hour and incorporate human genomic quality controls.

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