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GenMark Fungal Blood Culture Test Clears FDA

NEW YORK (GenomeWeb) – GenMark Diagnostics announced today it has received 510(k) clearance from the US Food and Drug Administration for a molecular diagnostic panel assay to detect fungal pathogens from blood cultures of patients with suspected bloodstream infections. 

The test is called the ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel. It runs on the firm's ePlex system, which utilizes microfluidics-based DNA hybridization to signal and capture probes as well as electrochemical detection technologies.

GenMark said in a statement that the BCID-FP has the broadest coverage of fungal pathogens of all commercially available molecular panels. The panel also includes resistant and emerging fungal strains. The firm lists 15 fungal pathogens contained in the panel on its website, including 11 different species of Candida. By comparison, the BioFire BCID panel can detect five Candida species.

The GenMark BCID-FP is the second panel approved out of three assays that the firm has developed to detect pathogens in blood cultures. GenMark received FDA clearance last week for a test to identify Gram-positive bacteria in blood cultures, called BCID-GP, and its assay for Gram-negative bacteria was submitted to the agency in September and is still under review, the firm said.

"We expect BCID to be a key contributor to our 2019 performance, driving both ePlex placements and assay sales," said Hany Massarany, GenMark's president and CEO.

The ePlex system itself cleared the FDA last year with a panel to detect viral and bacterial respiratory pathogens, potentially increasing competition in the multiplexed molecular panel space among systems like BioMérieux's BioFire FilmArray, Luminex xTAG, Luminex's Verigene, as well as phenotypic assays like Accelerate Diagnostics' Pheno system.