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GEN News Highlights : Sep 12, 2012

FDA Okay for Respiratory Virus Test Panel

GenMark Diagnostics received 510(k) clearance for its eSensor® Respiratory Virus Panel, for use on the XT-8 system. The assay is designed to simultaneously detect and differentiate 14 viruses and viral subtypes from patients with influenza-like symptoms, including rhinovirus, enterovirus, and clinically relevant adenovirus infections. “The FDA clearance of our eSensor Respiratory Virus Panel test further demonstrates the capability of our uniquely differentiated electronic detection technology,“ comments Hany Massarany, GenMark president and CEO.

GenMark’s e-Sensor XT-8 system is designed to support a range of molecular diagnostic tests carried out in self-contained, disposable test cartridges. In addition to the Respiratory Virus Panel, three additional tests have been cleared by FDA: Cystic Fibrosis Genotyping Test, Warfarin Sensitivity Test, and Thrombophilia Risk Tests. Other tests, including HCV genotyping and 2C19, are in development.