ParagonDx, a genetic and molecular testing diagnostics company based in Morrisville, N.C., has received clearance from the US Food and Drug Administration (FDA) to market its in vitro diagnostic test for warfarin sensitivity.
Warfarin, also known as Coumadin(R), is a blood thinner that prevents and treats blood clots. The therapeutic effect for warfarin can vary up to 120-fold between individuals depending on their genetic make-up.
ParagonDx's warafin diagnostic test is the first cleared product that can be done within a one-hour turnaround time, bringing a significant advantage to patients because their treatment can be customized quickly.
Patients who are warfarin-sensitive (need less medication) are at a higher risk of life-threatening bleeding during the initiation phase. Conversely, warfarin-resistant patients (need more medication) won't reach therapeutic levels if they are started at normal doses.
"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."
In the U.S., there are over 30 million patients being treated on a regular basis with warfarin. Two million of those are new patients just beginning warfarin treatment. In August 2007, the FDA relabeled warfarin to recommend that genetic testing be performed before initiating warfarin therapy.