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GenMark Receives CE Mark for ePlex BCID Gram-Positive and Gram-Negative Panels

NEW YORK (GenomeWeb) – GenMark Diagnostics said after the market closed on Thursday that it has achieved CE marking for its ePlex BCID gram-positive and gram-negative panels.

The firm noted that with CE marking for the BCID-GP and BCID-GN panels, it has achieved the designation for its ePlex family of sepsis panels, which also includes the BCID Fungal Pathogen Panel that achieved the CE mark in April.

"This rounds out our family of ePlex bloodstream infection assays, which we've designed to offer the broadest pathogen inclusivity and drug resistance markers of any multiplex molecular solution on the market today," Hany Massarany, president and CEO of GenMark, said in a statement. He said that GenMark believes the three BCID panels "will have a significant impact on the management of a critical disease state, while bringing clinical, economic, and quality benefits to ePlex customers and their patients."

Earlier this month, GenMark received 510(k) clearance from the US Food and Drug Administration for its ePlex instrument and Respiratory Pathogen Panel, which detects more than 20 viral and bacterial pathogens that commonly cause upper respiratory infections.

It also increased the size of a previously announced public offering to 6,382,978 shares of its common stock priced at $11.75 per share. The gross proceeds to GenMark, before deducting the underwriting discounts and commissions and estimated offering expenses, are expected to be about $75.0 million.

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