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GenMark gets CE mark approval for ePlex molecular diagnostics system

MDBR Staff Writer Published 09 June 2016

GenMark Diagnostics has secured CE mark approval for its ePlex instrument system and ePlex respiratory pathogen (RP) panel.

The ePlex is a sample-to-answer multiplex molecular diagnostics system, which incorporates sample preparation steps, including extraction and amplification.

It also features eSensor detection technology, which will enable to identify several molecular targets on a single test cartridge.

The ePlex RP Panel, which is available on the ePlex system, can find 20 viral and three bacterial targets in nasopharyngeal specimens.

GenMark has also started installing ePlex Systems in US clinical trial sites to complete clinical studies, in a bid to obtain approval from the US Food and Drug Administration (FDA).

The trails are expected to be completed in the third quarter of this year.

GenMark president and CEO Hany Massarany said: "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.

"Interest in ePlex has remained very strong as evidenced by the more than 15 European customer agreements we've already secured."

GenMark is engaged in the development of automated and multiplex molecular diagnostic testing systems, which detect and measure DNA and RNA targets to diagnose disease and optimize patient treatment.