ParagonDx receives FDA approval for blood thinner genetics test

Morrisville, N.C. — ParagonDx, a Triangle-based startup focused on genetic testing, has received approval from the U.S. Food and Drug Administration for its blood thinner sensitivity test.

The “Rapid Genotyping Assay” from ParagonDx identifies if a patient might have a negative reaction to the blood thinner warfarin. The blood thinner is used to prevent and threat blood clots.

ParagonDx’s product can deliver results in less than one hour. The test focuses on two genotypes (CYP2C9 and VKORC1) and variations in those that indicate a greater risk for reaction to warfarin.

More than 30 million people in the U.S. are treated with warfarin, and between 10-16 percent of patients can react negatively, according to ParagonDx. Reactions include excessive bleeding.

“Our genetic kit represents a significant advancement towards dealing with a potentially life threatening situation,” said Michael Murphy, ParagonDx’s chief executive officer. “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.”