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GenMark Gets CE Mark for ePlex System, Respiratory Pathogen Panel

NEW YORK (GenomeWeb) – GenMark Diagnostics said Wednesday that it has garnered CE IVD marking for its ePlex instrument system and ePlex Respiratory Pathogen Panel.

The ePlex molecular diagnostics system integrates sample preparation with GenMark's eSensor technology to enable the detection of multiple molecular targets on a single test cartridge.

The ePlex RP Panel detects 20 viral and three bacterial targets in nasopharyngeal specimens with less than two minutes of hands-on time. GenMark said it is the first of many similar cartridges expected to be made available for the ePlex system.

"Achieving CE Mark for ePlex has been an important goal for our company," GenMark President and CEO Hany Massarany said in a statement. "We are delighted to have accomplished this key milestone and are now focused on installing ePlex Systems in European early adopter customer sites."

Massarany added that GenMark has already secured more than 15 European customer agreements for the ePlex system.

In addition, GenMark has begun installing ePlex Systems at US clinical trial sites to complete the studies necessary to obtain clearance of the ePlex System and RP Panel from the US Food and Drug Administration. These studies are expected to be completed during the third quarter, with FDA submission expected towards the end of the third quarter or beginning of the fourth quarter of this year, the company said.