FDA grants emergency clearance for GenMark take a look at that screens for the flu, coronavirus and different viruses


A medical employee takes a nasal swab pattern from a scholar to check for COVID-19 on the Brooklyn Well being Medical Alliance pressing care pop up testing web site as an infection charges spike on October 8, 2020 in New York Metropolis.

Angela Weiss | AFP | Getty Pictures

California-based lab take a look at producer GenMark Diagnostics introduced Thursday that the Meals and Drug Administration granted emergency authorization for its fast molecular take a look at that may distinguish between greater than 20 totally different viruses and micro organism, together with the coronavirus.

Flu and Covid-19 sufferers usually develop comparable signs early on within the virus, which may make it tough this flu season for medical doctors and nurses to diagnose sufferers and pursue one of the best remedy. Assessments like GenMark’s which can be capable of concurrently display for the flu, the coronavirus and different pathogens might be essential to serving to hospitals successfully deal with Covid-19 and influenza sufferers this winter, public well being specialists say.

“Whereas we will not predict what chilly and flu season goes to appear to be this yr, we all know that we’ve got to arm healthcare suppliers with the required instruments to shortly and precisely diagnose the reason for infections in critically unwell sufferers, so syndromic testing goes to be crucial,” Scott Mendel, GenMark’s CEO, stated in an announcement.

The take a look at, known as ePlex Respiratory Pathogen Panel 2, offers leads to lower than two hours, in keeping with the corporate. It added that the take a look at was funded partly by the Biomedical Superior Analysis and Growth Authority, which is part of the Division of Well being and Human Providers. 

The take a look at was accepted to be used in Europe a few month in the past, the corporate stated. The FDA previously authorized a GenMark’s diagnostic take a look at for the coronavirus.