ParagonDx granted clearance for warfarin sensitivity test

ParagonDx’s genotyping assay is said to be the first cleared product to deliver results in less than one hour and incorporate human genomic quality controls. The ParagonDx test can be used to help prevent some of the most serious adverse events for warfarin patients including excessive bleeding which occurs in 10% to 16% of all patients.

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.

Michael Murphy, president and CEO of ParagonDx, said: “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.”