Trimgen Corporation Submits 510k to FDA for Warfarin Genotyping Kit
Product News Dec 10, 2007
At the 49th Annual Meeting of the American Society of Hematology, TrimGen Corporation will announce the completion of a clinical trial and submission of an application to the FDA for 510K approval for its eQ-PCR™ LightCycler Warfarin Genotyping Kit.
Performed on the Roche LightCycler® platform, TrimGen’s eQ-PCR™ LightCycler Warfarin Genotyping Kit is a DNA test that identifies key SNPs in the CYP2C9 and VKORC1 genes.
Over 5000 tests were performed during the clinical trial for this product. The results showed 100% agreement between the eQ-PCR™ LightCycler Warfarin system and the corresponding bi-directional sequencing method.
Warfarin is the most frequently prescribed oral anticoagulant for the treatment and prevention of thromboembolic events. Warfarin, however, is known to cause severe bleeding, a side effect resulting from inter-individual variability in response to the drug.
Inter-individual variability is primarily affected by genetic polymorphisms (SNPs) in the VKORC1 (vitamin K expoxide reductase complex subunit 1) and cytochrome P450 CYP2C9 genes. These genetic markers serve as clinically relevant predictors of Warfarin dosing.
The eQ-PCR™ LightCycler Warfarin Genotyping Kit is designed to provide patient genetic information that aids in the identification of side-effect risk factors that can be addressed with adjusted dosage, factors which include sensitivity to Warfarin, increased risk for bleeding complications, and inconsistent drug response.