TrimGen Corp, a molecular diagnostic company, announced that it has received FDA 510(k) clearance to market its eQ-PCR™ LC Warfarin Genotyping kit.

The assay is to be used as an aid in the identification of patients who may be at risk of warfarin sensitivity.

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.

"The FDA approval is an important milestone for TrimGen. It indicates that our eQ-PCR technology has met the regulatory challenges; our efforts warrant not only a simple, accurate diagnostic test but also the future commercial success of the company," commented Dr Howard Doong of TrimGen Corporation.

"We are delighted to be able to contribute and continue to advance the field of pharmacogenetics and the practice of personalized medicine," remarked Dr. Doong. "eQ-PCR LC Warfarin Genotyping assay is similar to other LightCycler® tests, which means that it will be quite simple for many clinical laboratories already using LightCycler to adopt our assay."