GenMark Submits Respiratory Viral Panel Test for FDA 510(k) Clearance

GenMark Diagnostics, Inc.,

announced today that it has submitted to the U.S. Food and Drug Administration, for 510 clearance, a Respiratory Viral Panel for use on its eSensor XT-8 system. The test is designed to identify multiple viruses from individuals exhibiting signs and symptoms of respiratory infection. The eSensor Respiratory Viral Panel is designed to be a fast, easy-to-use molecular diagnostic test to provide accurate results while requiring less technologist time.