Home Business FDA grants emergency clearance for GenMark test that screens for the flu, coronavirus and other viruses

FDA grants emergency clearance for GenMark test that screens for the flu, coronavirus and other viruses

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FDA grants emergency clearance for GenMark test that screens for the flu, coronavirus and other 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 testing website as an infection charges spike on October 8, 2020 in New York Metropolis.

Angela Weiss | AFP | Getty Photos

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

Flu and Covid-19 sufferers usually develop related signs early on within the virus, which may make it troublesome this flu season for medical doctors and nurses to diagnose sufferers and pursue the most effective therapy. Assessments like GenMark’s which might be capable of concurrently display for the flu, the coronavirus and different pathogens may very well 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 won’t predict what chilly and flu season goes to seem like this yr, we all know that now we have to arm healthcare suppliers with the required instruments to rapidly and precisely diagnose the reason for infections in significantly unwell sufferers, so syndromic testing goes to be important,” Scott Mendel, GenMark’s CEO, mentioned in an announcement.

The check, referred to as ePlex Respiratory Pathogen Panel 2, makes use of a nasopharyngeal swab to gather samples and supplies ends in lower than two hours, based on the corporate. It added that the check was funded partly by the Biomedical Superior Analysis and Growth Authority, which is part of the Division of Well being and Human Companies. Via the contract, BARDA awarded as much as $749,000 to the corporate for the event of the check, the corporate mentioned in March.

The check was accredited to be used in Europe a couple of month in the past, the corporate mentioned. The FDA beforehand licensed a GenMark’s diagnostic check for the coronavirus. 

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