Machaon Diagnostics, a US-based laboratory for testing bleeding and clotting disorders, has launched a clinical testing service for patients that have been prescribed anticoagulant warfarin, also known as Coumadin, Jantoven or warfarin sodium.
Machaon’s FDA-approved array-based technology detects genetic variations in 2 key genes involved in the metabolism of warfarin. 40% of the general population in the US are said to have at least one of these genetic variations, which can lead to over 5-fold differences in weekly warfarin dose. Over 6% of these patients are expected to experience an adverse bleeding or clotting event. FDA has recognized these risks by placing its strongest warning in the form of a Black Box Warning on warfarin package inserts.
Machaon’s testing service provides physicians the valuable genetic information with a ‘same-day’ test result, thereby limiting the need for trial and error dosing unlike in traditional warfarin dosing, as many of the risks can be avoided when genetic information is used to determine an accurate initial dose.
Machaon said that the genetically-tuned starting doses have the potential of improving the safety of warfarin’s use by allowing for individualized therapy. Often, however, the precious genetic information is not available or it is only available after 10 days and well past the window where it can reasonably influence the starting dose.
Brad Lewis, hematologist, medical director of Machaon Diagnostics, said: “With warfarin being the second most common trigger for emergency room visits, our goal in designing this service was to enable physicians to accurately identify a safe warfarin dose for their patients within a timeframe that was meaningful. We believe that we are the first clinical laboratory in the US to offer this genetic testing service that provides results the ‘same-day’ a blood specimen is received.”