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Nanosphere Announces First FDA Cleared Genetic Test for Warfarin Sensitivity and Nanotechnology-based Molecular Diagnostics PlatformNORTHBROOK, IL | Posted on September 18th, 2007
Nanosphere, Inc., a nanotechnology-based molecular diagnostics company, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for the Verigene® System, a random access, molecular diagnostics workstation for nucleic acid and protein diagnostics. The company also announced FDA clearance of the Verigene System's first test to determine an individual's ability to metabolize the anti-coagulant medication warfarin, information critical to determining safe and appropriate dosing. This announcement marks clearance of a medical diagnostics platform based on nanotechnology for clinical use, as well as the first test cleared by the FDA to determine warfarin metabolism.
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