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GenMark Submits ePlex Blood Culture ID Gram-Positive Panel for FDA Clearance

NEW YORK (GenomeWeb) – GenMark Diagnostics said Thursday that it has applied to the US Food and Drug Administration for clearance of its ePlex Blood Culture ID – Gram Positive (BCID-GP) panel.

It is the first of three blood culture panels being developed on the ePlex molecular sample-to-answer system for the diagnosis and management of bloodstream infections that can lead to sepsis, the firm said.

GenMark said that it anticipates FDA submission of a Gram Negative panel (BCID-GN) and a Fungal Pathogen panel (BCID-FP) in the third and fourth quarters of this year. GenMark recently initiated a clinical study for its BCID-GN panel and is in the final stages of preparation of a clinical study for its BCID-FP panel.

"The FDA submission of our ePlex BCID-GP panel marks an important milestone for GenMark, as we continue to expand our menu of multiplex molecular panels across multiple infectious diseases," Hany Massarany, GenMark's president and CEO, said in a statement.

In June 2017, GenMark received CE marking for its ePlex BCID gram-positive and gram-negative panels.

Also in June last year, the firm 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.