Genotyping Assay Quickly Identifies Patients Sensitive to Warfarin

It delivers results in less than one hour and incorporates human genomic quality controls. This rapid turnaround time means that treatment can be customized quickly and the chance that a patient will have excessive bleeding or suffer other adverse events such as heart attack or stroke will decrease.

The Rapid Genotyping assay is to be used to detect the presence of variations in the genes CYP2C9 and VKORC1. Information about the CYP2C9 and VKORC1 genotypes may be used as an aid in the identification of patients at greater risk for warfarin sensitivity. Warfarin, also known as Coumadin, is a blood thinner that prevents and treats blood clots.

ParagonDx (Research Triangle Park, NC, USA) has been given clearance by the U.S. Food and Drug Administration (FDA; Rockville, MD, USA; www.fda.gov) to market the genotyping test. Warfarin is the most prescribed oral anticoagulant in North America.

Warfarin is the second most common drug, after insulin, implicated in emergency room visits for adverse drug events. The FDA's Adverse Event Reporting system indicated that warfarin is among the top 10 drugs with the largest number of serious adverse event reports submitted during the 1990 and 2000 decades. Of the 30 million Americans who regularly take warfarin, between 10 and 16% are genetically predisposed to be sensitive to the drug. An estimated two million people start taking warfarin each year.

"Our genetic kit represents a significant advancement towards dealing with a potentially life threatening situation,” said Michael Murphy, president and CEO of ParagonDx. "An individual's genetic make-up clearly affects his or her response to warfarin. Getting this information to physicians quickly will decrease the chance that patients will have excessive bleeding or another heart attack or stroke. The inclusion of quality controls in the kit will provide the kind of assurance that laboratories need to ensure accuracy and reliability.”

ParagonDx is a provider of applied molecular diagnostic products. The company develops and markets reference controls for laboratory quality control and diagnostic kits that bring the promise of personalized medicine to physicians and patients.


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