ParagonDx Receives FDA 510(k) Marketing Clearance For Warfarin Sensitivity Genotyping Kit

Main Category: Blood / Hematology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 07 May 2008 - 2:00 PDT

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ParagonDx, a leader in genetic testing diagnostics, has received 510(k) marketing clearance from the US Food and Drug Administration (FDA) for its in vitro diagnostic test. 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's genotyping assay is the first cleared product to deliver results in less than one hour and incorporate human genomic quality controls.

In the US 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. 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.

This is the first test that can easily be done within a one-hour turnaround time, bringing a significant advantage to patients because their treatment can be customized quickly, when time is of the essence.

"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's Rapid Genotyping Assay - CYP2C9 & VKORC1 was cleared by the FDA using the Cepheid's SmartCycler® Dx platform.

About ParagonDx

ParagonDx, located in Research Triangle Park, NC, is a leading provider of applied molecular diagnostic products. Initially a pioneer in the field of pharmacogenomics, ParagonDx has broadened it expertise into molecular diagnostic products. ParagonDx develops and markets reference controls for laboratory quality control and diagnostic kits that bring the promise of personalized medicine to physicians and patients. ParagonDx was the first company to bring FDA-cleared human genomic reference controls to the market. These products will enhance patient safety, improve patients' response to therapy and help realize the promise of personalized medicine.

ParagonDx