Rapid Genetic Test for Warfarin Sensitivity Cleared
A new warfarin sensitivity test (pdf), the Rapid Genotyping Assay, was introduced by ParagonDx. The company has also been awarded regulatory approval by the Food and Drug Administration, as reported on the company website. It is expected that the test will be made available within the next few months.
The genetic test identifies patients who are likely to react poorly to standard doses of warfarin treatment, a blood thinner commonly utilized to prevent blood clots. The test identifies patients who carry variations of either the CYP2C9 or VKORC1 genes. Those individuals are more likely to have a warfarin sensitivity.
It is intended for use among patients who have had either a stroke or heart attack. Identifying these patients before treatment can reduce the risk that patients will bleed excessively. The company presented a poster (pdf) at the Association for Molecular Pathology describing data. Importantly, the FDA modified guidelines in 2007 suggesting that patients who would be treated with warfarin undergo genetic testing to assess sensitivity.
This is the third test to evaluate patients for a warfarin sensitivity that has been approved by the FDA. One advantage of the Paragon test compared to the other two already available is that the test has a rapid turnaround time of one hour. As such, testing can be completed in the emergency room setting. With that information available quickly, physicians can base warfarin dosing considering any genetic predisposition to sensitivity.
This is the first product from ParagonDx to receive marketing clearance in the U.S. The small company is developing a number of other genetic tests. One product in the works is a test to identify women with breast cancer who are candidates for treatment with tamoxifen.
May 8, 2008 Related topics: Laboratory Equipment, Product Approval & Certification, Product Launches, Diagnostic, Surgery, Hematology & Oncology, Orthopedic, Emergency