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GenMark Diagnostics Obtains FDA Clearance for Gram-Negative Sepsis Panel

NEW YORK (GenomeWeb) - GenMark Diagnostics said today it has received 510(k) clearance from the US Food and Drug Administration for a panel assay to detect gram-negative bacteria in blood cultures.

The ePlex Blood Culture Identification Gram-Negative (BCID-GN) Panel detects 21 gram-negative bacteria, six resistance genes, and pan targets for gram-positive organisms and Candida, according to the firm's website. It completes GenMark's suite of multiplex panels to detect bloodstream infections that can cause sepsis, the firm said in a statement.

GenMark previously received clearance from the FDA for its ePlex Blood Culture Identification Gram-Positive (BCID-GP) and Fungal Pathogen (BCID-FP) panels. The BCID assays run on GenMark's ePlex system, which uses competitive DNA hybridization and electrochemical detection with the firm's eSensor detection technology and provide results in about 1.5 hours with less than two minutes of hands-on time.

Overall, the panels "provide broad coverage of organisms and resistance markers that can lead to sepsis, including anaerobes and multidrug resistant organisms ... as well as common and emerging fungal pathogens," said Hany Massarany, GenMark's president and CEO, in a statement.

The firm estimates a $500 million global market for the BCID panels and expects them to be a key contributor to its 2019 performance, "driving both ePlex placements and assay sales," Massarany said.

The ePlex system also runs the firm's multiplex respiratory pathogen test, and GenMark has a central nervous system infection panel, a gastrointestinal panel, and a hepatitis C genotyping panel in the pipeline for the ePlex system.