GenMark achieves CE mark for its ePlex® Sample-to-Answer system

European customer agreements in place for initial systems.

GenMark Diagnostics, a provider of automated, multiplex molecular diagnostic testing systems, announced it has achieved CE Mark under the European In?Vitro Diagnostic Devices Directive (98/79/EC) for its ePlex Instrument System and ePlex Respiratory Pathogen (RP) Panel.

“Achieving CE Mark for ePlex has been an important goal for our Company. We are delighted to have accomplished this key milestone and are now focused on installing ePlex Systems in European early adopter customer sites,” said Hany Massarany, President and Chief Executive Officer of GenMark. “Interest in ePlex has remained very strong as evidenced by the more than 15 European customer agreements we’ve already secured,” added Massarany.

In addition, the Company has begun installing ePlex Systems in U.S. clinical trial sites for completion of clinical studies necessary to obtain clearance of the ePlex System and RP Panel from the U.S. Food and Drug Administration (FDA). 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.

ePlex is a sample-to-answer multiplex molecular diagnostics System which integrates sample preparation steps including extraction and amplification, together with the Company’s proprietary eSensor® detection technology, to allow the detection of multiple molecular targets on a single test cartridge. The ePlex RP Panel is the first of many assays expected to be available on the ePlex System. With less than two minutes of operators’ hands-on time, the ePlex RP Panel detects 20 viral and three bacterial targets in nasopharyngeal specimens.

GenMark Diagnostics is a provider of automated, multiplex molecular diagnostic testing systems that detect and measure DNA and RNA targets to diagnose disease and optimize patient treatment. Utilizing GenMark’s proprietary eSensor® detection technology, GenMark’s eSensor XT-8® system is designed to support a broad range of molecular diagnostic tests with a compact, easy-to-use workstation and self-contained, disposable test cartridges. The eSensor detection technology is also incorporated into GenMark’s sample-to-answer system, ePlex®.

Source: GenMark Diagnostics