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ParagonDx Launches Genetic Test For warfarin sensitivity

ParagonDx LLC is offering genetic testing for warfarin sensitivity to local doctors and patients. The test will help doctors prevent excessive bleeding in those patients who are taking warfarin (Coumadin), a common anti-coagulant prescribed to prevent and treat blood clots. Doctors by using this test can understand the genetic component which can help achieve the optimal level of warfarin. This kind of testing has been shown to lower the risk of potential life-threatening adverse drug reactions. The US Food and Drug Administration relabeled warfarin in 2007 to recommend that patients receive genetic testing prior to the initiation of warfarin therapy. This testing is a marked change in how warfarin was previously prescribed by doctors. Due to the wide variation in how people metabolize warfarin, doctors have had to determine the correct dose for each individual patient by trial and error, adjusting the medication dosage for up to 30 days. Many patients are at risk of developing serious or even fatal adverse reactions during this time period. Too much warfarin can lead to excessive bleeding episodes, while too little can increase the chance of stroke. ParagonDx will provide collection devices and instructions to doctors. While visiting their physician, patients will provide a sample, either of blood or simply a saliva sample. ParagonDx will analyze the samples at its CLIA (Clinical Laboratory Improvement Amendments) laboratory and provide results the next day. This represents a vast improvement over other labs, which can take as long as five days to generate results for this test. The rapid turnaround time provides a significant advantage to patients, because they can begin taking the appropriate warfarin dose right away. “From the patient’s perspective, the benefits of this test are enormous,” said Michael P. Murphy, president and CEO of ParagonDx. “Warfarin therapy saves lives. With our test, a new warfarin patient can safely begin optimized therapy based on his or her own personal genetic makeup. This is truly personalized medicine.” In order to conduct this genetic test, ParagonDx was designated as a CLIA lab by the Centers for Medicare & Medicaid Services (CMS) which regulates all laboratory testing (except research) performed on humans in the United States.