TrimGen Corporation Received FDA 510(k) Approval For Warfarin Genotyping Kit

Main Category: Blood / Hematology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 19 Feb 2009 - 2:00 PDT

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TrimGen Corporation, a molecular diagnostic company, announced that it has received FDA 510(k) clearance to market its eQ-PCR(TM) LC Warfarin Genotyping kit. This assay is to be used as an aid in the identification of patients who may be at risk of warfarin sensitivity.

Warfarin is the most frequently prescribed oral anticoagulant used to prevent heart attack, stroke and blood clot formation. However, it 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.

"The FDA approval is an important milestone for TrimGen. It indicates that our eQ-PCR(TM) 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(TM) LC Warfarin Genotyping assay is similar to other LightCycler(R) tests, which means that it will be quite simple for many clinical laboratories already using LightCycler(R) to adopt our assay."

Detailed information about the eQ-PCR(TM) LC Warfarin Genotyping Kit can be found at http://www.TrimGen.com.

About TrimGen

TrimGen is a biotechnology company focused on developing nucleic acid-based diagnostics products. The company's proprietary technologies, eQ-PCR(TM) and Shifted Termination Assay(TM) (STA), are highly sensitive detection methods used to identify target genes and SNPs at very low levels. The STA technology is a unique mutation enrichment process that has been recently applied for detection of drug resistant KRAS mutations in patients with colorectal cancer. Products in development include assays for leukemia, lymphoma, solid tumor, blood disorder and infectious diseases.

TrimGen Corporation

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