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GenMark Diagnostics Receives FDA Clearance for ePlex BCID Gram-Positive Panel

NEW YORK (GenomeWeb) – GenMark Diagnostics said today that it has received US Food and Drug Administration 510(k) clearance for its ePlex Blood Culture Identification Gram-Positive (BCID-GP) Panel.

The firm had announced toward the end of June that it applied to the FDA for market clearance.

The Carlsbad, California-based molecular diagnostics firm has developed the gram-positive panel and ePlex Blood Culture Identification Gram-Negative (BCID-GN) and Fungal Pathogen (BCID-FP) panels for the diagnosis and disease management of bloodstream infections that can lead to sepsis.  

GenMark applied for marketing clearance for its gram negative and fungal pathogen panels in October, and those panels are currently under FDA review.

The firm said that the BCID panels — running on its ePlex sample-to-answer system — deliver benefits designed to improve patient care and antimicrobial stewardship with broad organism inclusivity and resistance-gene coverage. 

"Test menu expansion will remain a priority for us as we continue our diligent development and clinical efforts to unlock the full potential of the ePlex system," GenMark President and CEO Hany Massarany said in a statement.

Further, the firm's ePlex software platform links results from tests to localized antimicrobial stewardship guidelines to help guide treatment decisions, he said.

GenMark received CE marking for its ePlex BCID gram-positive and gram-negative panels in June 2017, and in the same month it received 510(k) clearance for its ePlex instrument and Respiratory Pathogen Panel, which detects more than 20 viral and bacterial pathogens that commonly cause upper respiratory infections.