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GenMark Secures FDA Clearance For Respiratory Virus Panel Test - Quick Facts

GenMark Diagnostics, Inc. (GNMK) said it obtained 510(k) clearance from the U.S. Food and Drug Administration, or FDA, for its eSensor Respiratory Virus Panel for use on its XT-8 system. This test is intended to simultaneously detect and differentiate 14 clinically relevant viruses from patients with influenza-like illness.

The company noted that the eSensor RVP test has the potential to significantly improve patient care by delivering superior co-infection detection, distinguishing Rhinovirus from Enteroviruses and identifying clinically relevant Adenoviruses.

According to GenMark, with rapid processing and minimal hands-on time required from laboratory staff, its eSensor RVP test enables clinical laboratories to rapidly report actionable patient results to physicians, while efficiently managing the fluctuating testing workload associated with this seasonal illness.

by RTT Staff Writer

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