GenMark Diagnostics has 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.