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

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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 pupil to check for COVID-19 on the Brooklyn Well being Medical Alliance pressing care pop up t


A medical employee takes a nasal swab pattern from a pupil 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 Photos

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 completely different viruses and micro organism, together with the coronavirus.

Flu and Covid-19 sufferers sometimes develop related signs early on within the virus, which might make it troublesome this flu season for docs and nurses to diagnose sufferers and pursue the most effective therapy. Exams like GenMark’s which might be in a position to concurrently display for the flu, the coronavirus and different pathogens could possibly be essential to serving to hospitals successfully deal with Covid-19 and influenza sufferers this winter, public well being specialists say.

Shares of Genmark shot up about 15% after the shut however pared good points and have been up greater than 4% in after-hours buying and selling.

“Whereas we will not predict what chilly and flu season goes to seem like 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, mentioned in a press release.

The take a look at, referred to as ePlex Respiratory Pathogen Panel 2, makes use of a nasopharyngeal swab to gather samples and gives ends in lower than two hours, in keeping with the corporate. It added that the take a look at was funded partially by the Biomedical Superior Analysis and Improvement Authority, which is part of the Division of Well being and Human Providers. By the contract, BARDA awarded as much as $749,000 to the corporate for the event of the take a look at, the corporate mentioned in March.

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



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