FDA News

Nanosphere Announces First FDA Cleared Genetic Test for Warfarin Sensitivity and Nanotechnology-based Molecular Diagnostics Platform

(Sept 19, 2007)-- Nanosphere, nanotechnology-based molecular diagnostics company, 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.

The FDA recently approved updated labeling information for the blood-thinner warfarin, sold under the brand name Coumadin. The new label explains that patients with variations in two genes, CYP2C9 and VCORC1, may respond differently to the drug. Genetic testing for these variations is expected to help doctors determine appropriate dosing levels for individual patients, thus lowering the risks of bleeding complications. Warfarin is the most prescribed oral anticoagulant in North America and Europe with more than 12 million new prescriptions from July 2006 to June 2007 and it is the second most common drug, after insulin, implicated in emergency room visits for adverse drug events.

The Verigene System uses patented gold nanoparticle technology to detect nucleic acid targets in a multiplex format. The system is comprised of two core instruments, the Verigene Reader and the Verigene Processor, and a single use disposable test cartridge. Nanosphere designed the Verigene System to allow for the simultaneous detection of multiple genetic targets in the same Verigene Test Cartridge format.

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