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

CARLSBAD, Calif. -- (BUSINESS WIRE) -- GenMark Diagnostics, Inc., (NASDAQ: GNMK) announced today that it has submitted to the U.S. Food and Drug Administration (FDA), for 510(k) 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.

“The submission to the FDA of our eSensor Respiratory Viral Panel is an important step in GenMark’s continued commitment to providing our customers with high quality in-vitro diagnostic molecular tests for use with our award winning eSensor XT-8 system,” commented Hany Massarany, President and CEO of GenMark Diagnostics.

About GenMark Diagnostics, Inc.

GenMark Diagnostics is a leading provider of automated, multiplex molecular diagnostic testing systems that detect and measure DNA and RNA targets to diagnose disease and optimize patient treatment. Utilizing GenMark’s proprietary eSensor® detection technology, GenMark's eSensor® XT-8 system is designed to support a broad range of molecular diagnostic tests with a compact, easy-to-use workstation and self-contained, disposable test cartridges. GenMark currently markets three tests that are FDA cleared for IVD use: Cystic Fibrosis Genotyping Test, Warfarin Sensitivity Test, and Thrombophilia Risk Test. A number of other tests, including HCV Genotyping and 2C19, versions of which are available for research use only, and KRAS, are in development for IVD use. For more information, visit www.genmarkdx.com.

Safe Harbor Statement

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