Skip to main content
Premium Trial:

Request an Annual Quote

GenMark Gets CE Mark for ePlex System, Respiratory Pathogen Panel

NEW YORK (GenomeWeb) – GenMark Diagnostics said Wednesday that it has garnered CE IVD marking for its ePlex instrument system and ePlex Respiratory Pathogen Panel.

The ePlex molecular diagnostics system integrates sample preparation with GenMark's eSensor technology to enable the detection of multiple molecular targets on a single test cartridge.

The ePlex RP Panel detects 20 viral and three bacterial targets in nasopharyngeal specimens with less than two minutes of hands-on time. GenMark said it is the first of many similar cartridges expected to be made available for the ePlex system.

"Achieving CE Mark for ePlex has been an important goal for our company," GenMark President and CEO Hany Massarany said in a statement. "We are delighted to have accomplished this key milestone and are now focused on installing ePlex Systems in European early adopter customer sites."

Massarany added that GenMark has already secured more than 15 European customer agreements for the ePlex system.

In addition, GenMark has begun installing ePlex Systems at US clinical trial sites to complete the studies necessary to obtain clearance of the ePlex System and RP Panel from the US Food and Drug Administration. 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, the company said.

The Scan

Support for Moderna Booster

An FDA advisory committee supports authorizing a booster for Moderna's SARS-CoV-2 vaccine, CNN reports.

Testing at UK Lab Suspended

SARS-CoV-2 testing at a UK lab has been suspended following a number of false negative results.

J&J CSO to Step Down

The Wall Street Journal reports that Paul Stoffels will be stepping down as chief scientific officer at Johnson & Johnson by the end of the year.

Science Papers Present Proteo-Genomic Map of Human Health, Brain Tumor Target, Tool to Infer CNVs

In Science this week: gene-protein-disease map, epigenomic and transcriptomic approach highlights potential therapeutic target for gliomas, and more