GenMark Diagnostics Receives FDA 510(k) Market Clearance for its ePlex Blood Culture Identification Gram-Negative Panel
GENMARK DIAGNOSTICS (GNMK)
Last genmark diagnostics earnings: 3/2 04:05 pm
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Source: GlobeNewswire
CARLSBAD, Calif., April 15, 2019 (GLOBE NEWSWIRE) -- GenMark Diagnostics, Inc. (NASDAQ:GNMK), a leading provider of automated, multiplex molecular diagnostic testing systems, today announced that it has received FDA 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for its ePlex Blood Culture Identification Gram-Negative (BCID-GN) Panel. This is the third ePlex BCID Panel to receive FDA clearance during the past four months. GenMark’s complete family of ePlex BCID Panels, including the Gram-Negative (BCID-GN), Gram-Positive (BCID-GP) and Fungal Pathogen (BCID-FP) Panels, were developed on the Company’s ePlex sample-to-answer system for the diagnosis and disease management of bloodstream infections (BSI) that can lead to sepsis. “The ePlex BCID Panels provide broad coverage of organisms and resistance markers that can lead to sepsis, including anaerobes and multidrug resistant organisms (MDRO), as well as common and emerging fungal pathogens. We are excit
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