GenMark Diagnostics Inc, Carlsbad, Calif, has received the CE mark for its ePlex instrument system and ePlex respiratory pathogen (RP) panel.
Hany Massarany, GenMark Diagnostics.
“Achieving CE mark for ePlex has been an important goal for our company,” says Hany Massarany, president and chief executive of GenMark. “We are delighted to have accomplished this key milestone and are now focused on installing ePlex systems in European early adopter customer sites.” The company has secured more than 15 European customer agreements, Massarany adds.
In addition, the company has begun installing ePlex Systems in US clinical trial sites for completion of clinical studies necessary to obtain FDA clearance. The studies are expected to be completed during the third quarter of 2106, with FDA submission expected toward the end of the third quarter or beginning of the fourth quarter of the year.
The ePlex instrument system from GenMark Diagnostics.
The ePlex sample-to-answer multiplex molecular diagnostics system integrates sample preparation steps, including extraction and amplification, with the company’s proprietary eSensor detection technology, to allow the detection of multiple molecular targets on a single test cartridge. With less than 2 minutes of operator hands-on time, the ePlex RP panel detects 20 viral and three bacterial targets in nasopharyngeal specimens.
For more information, visit AACC booth 251 or GenMark Diagnostics.
