FDAnews
www.fdanews.com/articles/199065-genmarks-respiratory-pathogen-panel-earns-ce-mark
GenMark logo

GenMark’s Respiratory Pathogen Panel Earns CE Mark

September 16, 2020

GenMark has earned a CE mark for its ePlex Respiratory Pathogen Panel 2 (RP2), a molecular test for COVID-19, influenza and other common respiratory pathogens.

The test provides rapid results for “infections with similar symptoms such as fever, cough and body aches, which will be critical in preparing for fall and winter as the flu season coincides with the ongoing risk of COVID-19,” the company said.

The test delivers results in less than two hours for more than 20 viruses and bacteria that cause respiratory infections, including COVID-19, influenza A and B, respiratory syncytial virus (RSV) and rhinovirus.

Designed for use on the company’s ePlex system, the diagnostic test is awaiting an Emergency Use Authorization from the FDA for COVID-19.

View today's stories