US-based medical device company GenMark Diagnostics has received the CE mark approval for its ePlex Instrument System and ePlex Respiratory Pathogen (RP) Panel.
A sample-to-answer multiplex molecular diagnostics system, ePlex integrates sample preparation steps including extraction and amplification, together with the company’s patented eSensor detection technology.
The integration facilitates detection of multiple molecular targets on a single test cartridge.
The ePlex RP Panel is the first of many assays and is expected to be made available on the ePlex System. It detects 20 viral and three bacterial targets in nasopharyngeal specimens in less than two minutes of operators’ hands-on time.
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 have already secured."
GenMark is also installing the ePlex Systems into US clinical trials in order to complete the essential clinical studies to secure clearance of the ePlex System and RP Panel from the US Food and Drug Administration (FDA).
The studies are expected to be completed during the third quarter of this year, with FDA submission is expected to be carried out towards the end of the third quarter or beginning of the fourth quarter of this year.