Warfarin Genotyping Kit Receives FDA Nod

 

February 19, 2009

February 19, 2009 - Molecular diagnostic company TrimGen Corp. has received FDA 510(k) clearance to market its eQ-PCR LC Warfarin Genotyping kit, an assay used to aid identification of patients who may be at risk of warfarin sensitivity.

The most frequently prescribed oral anticoagulant used to prevent heart attack, stroke and blood clot formation, Warfarin is also the second most common drug implicated in emergency room visits for adverse drug events. Warfarin is known to cause severe bleeding, a side effect resulting from poor metabolism of the drug due to inter-individual variability. The variability is primarily affected by genetic polymorphisms (SNPs) in the VKORC1 and cytochrome P450 CYP2C9 genes. These genetic markers serve as clinically relevant predictors of warfarin dosing and are targets of the TrimGen kit.

Similar to the company’s other LightCycler tests, the eQ-PCR LC Warfarin Genotyping assay should be easy for clinical laboratories to adopt, said the company.

For more information: www.TrimGen.com

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