SPARKS, MD--(Marketwire - February 18, 2009) -
TrimGen Corporation, a molecular diagnostic
company, announced that it has received FDA 510(k) clearance to market its
eQ-PCR™ 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
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™ 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
"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
Detailed information about the eQ-PCR™ LC Warfarin Genotyping Kit can be
found at www.TrimGen.com.
TrimGen is a biotechnology company focused on developing nucleic acid-based
diagnostics products. The company's proprietary technologies, eQ-PCR™
and Shifted Termination Assay™ (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.