Sparks, Maryland (December 7, 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 provides accurate 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. Detailed information about the eQ-PCR™ LightCycler Warfarin Genotyping Kit can be found at www.trimgen.com.
