GenMark Diagnostics Receives FDA Clearance for its ePlex Blood Culture Identification Gram Negative Panel


GenMark Diagnostics has received FDA 510(k) market clearance from the U.S. 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 excited to bring to market the most comprehensive molecular test solution designed to improve the diagnosis and management of bloodstream infections, while delivering economic and quality benefits to our customers,” said Hany Massarany, President and Chief Executive Officer.

“We believe that the potential market opportunity for our BCID Panels could be as large as the available market for our Respiratory Pathogen (RP) Panel, which we estimate to be around $500 million globally. We expect BCID to be a key contributor to our 2019 performance, driving both ePlex placements and assay sales,” added Massarany.