GenMark receives FDA 510 clearance for ePlex BCID-FP panel

GenMark announced that it has received FDA 510 market clearance from the FDA for its ePlex blood culture identification fungal pathogen, or BCID-FP, panel. This panel, together with the ePlex blood culture identification gram-positive, or BCID-GP, and gram-negative panels, were developed for the diagnosis and disease management of bloodstream infections, or BSI, that can lead to sepsis. The BCID-FP panel has the broadest coverage of fungal pathogens compared to other commercially available molecular panels and includes many resistant and emerging strains, including Candida auris. Fungal pathogens are a growing cause of BSI and are associated with some of the highest mortality rates.

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