A Medical Device Daily

Nanosphere (NorthBrook, Illinois), a nanotechnology-based molecular diagnostics company, said that it has received FDA clearance for the Verigene system, a random access, molecular diagnostics workstation for nucleic acid and protein diagnostics. The company also reported 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 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 approval of the test comes a month after warfarin, sold under the brand name Coumadin and in generic forms, became the first widely used drug to include genetic testing information on its label (Medical Device Daily, Aug. 20, 2007).

Verigene uses 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.