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GenMark Receives FDA 510(k) Market Clearance for Its ePlex® Instrument and Respiratory Pathogen Panel

GENMARK DIAGNOSTICS (GNMK)  More Company Research Source: Business Wire
Last genmark diagnostics earnings: 7/30 04:05 pm Check Earnings Report
US:NASDAQ Investor Relations: ir.genmarkdx.com/investor-relations
PDF The True Sample-to-Answer Solution™ Brings New Capabilities to Multiplex Molecular Diagnostics CARLSBAD, Calif.--(BUSINESS WIRE)-- GenMark Diagnostics, Inc. (Nasdaq:GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, today announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration for both its ePlex instrument and Respiratory Pathogen (RP) Panel. ePlex is a transformational new in vitro diagnostic platform that integrates nucleic acid extraction, amplification, and detection processes into a fully automated, sample-to-answer system. Rapid and highly specific detection is enabled on ePlex by GenMark’s established and proven eSensor® technology, which has been used in more than two million patient tests conducted across multiple FDA-cleared panels on the Company’s XT-8 system. The introduction of ePlex to the U.S. market [Read more]

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