17 Aug Third Wave CEO applauds FDA on updated drug labeling
Madison, Wis. – The chief executive of Third Wave Technologies is applauding a recent announcement by the U.S. Food and Drug Administration approving the updated labeling for Coumadin, a widely used blood-thinning drug.
Kevin T. Conroy, president and CEO of Third Wave, welcomed the announcement, which directs manufacturers to include information regarding the potential affect of a patient’s genetic makeup on dosing of the drug.
Manufacturers of Warfarin, the generic version of Coumadin, have been directed to add similar information to their product labels.
The FDA believes genetic testing may help optimize the use of Warfarin, which it identifies as the second most common drug implicated in adverse drug events in emergency room visits, and lower the risk of bleeding complications from its use.
Earlier this year, Third Wave released reagents that enable clinical laboratories to build molecular assays, or tests, capable of detecting the specific mutations associated with warfarin sensitivity.
Conroy, who applauded the FDA’s efforts to move the study of genetic variation into clinical practice, said the company will provide an update on FDA submission plans for its own Warfarin products at its forthcoming analyst and investor day – Sept. 20 in New York.
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