GenMark Diagnostics announces FDA submission of its ePlex blood culture identification Gram-Negative and ePlex blood culture identification fungal pathogen panels

Submissions now complete for all three ePlex molecular multiplex panels designed for the diagnosis and management of bloodstream infections that can act to sepsis. GenMark Diagnostics, a provider of automated, multiplex molecular diagnostic testing systems, announced the submission of two additional ePlex Blood Culture Identification Panels – the Gram-Negative (BCID-GN) Panel and Fungal Pathogen (BCID-FP) Panel – to the U.S. Food and Drug Administration (FDA).

These panels, together with the ePlex BCID Gram-Positive (BCID-GP) Panel previously submitted to the FDA in June 2018, are being developed on the Company’s ePlex sample-to-answer system, for the diagnosis and disease management of bloodstream infections that can act to sepsis.

“The submissions of our BCID-GN and BCID-FP panels to the FDA signify our continued commitment to ePlex menu expansion, which is one of GenMark’s top priorities. Sepsis is a global healthcare priority and we are confident that our ePlex BCID solution will improve the management of patients with blood stream infections and help combat antibiotic resistance,” said Hany Massarany, President and Chief Executive Officer.

Source: http://ir.genmarkdx.com/