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GenMark Submits ePlex BCID Gram-Negative, Fungal Pathogen Panels for FDA Clearance

NEW YORK (GenomeWeb) – GenMark Diagnostics announced after the close of the market on Tuesday that it has applied to the US Food and Drug Administration for clearance of its ePlex Blood Culture Identification Gram-Negative (BCID-GN) and ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) panels.

As a result, the firm has now completed submissions for all three of its ePlex molecular multiplex panels designed for the diagnosis and management of bloodstream infections that can lead to sepsis. The panels are being developed on GenMark's ePlex sample-to-answer system.

"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," GenMark President and CEO Hany Massarany said in a statement.

He noted that sepsis is a global healthcare priority and that the firm is confident that its ePlex BCID solution "will improve the management of patients with bloodstream infections and help combat antibiotic resistance."

In June, the firm applied to the FDA for clearance of its ePlex Blood Culture ID – Gram Positive (BCID-GP) panel.

William Blair analyst Brian Weinstein said in a research note Tuesday that he continues "to have a positive bias on the long-term market potential for ePlex given the still underpenetrated market for multiplex diagnostics, the unique [information technology]-focused approach built into the instrument system, easy scalability, and what is still a belief in the management pedigree."

In early Wednesday morning trade on the Nasdaq, GenMark's shares were up less than 1 percent at $6.90.