FDA grants emergency clearance for GenMark take a look at that screens for the flu, coronavirus and different viruses
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Flu and Covid-19 sufferers sometimes develop comparable signs early on within the virus, which may make it troublesome this flu season for medical doctors and nurses to diagnose sufferers and pursue one of the best remedy. Checks 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.
Shares of Genmark shot up about 15% after the shut however pared features and had been up greater than 4% in after-hours buying and selling.
“Whereas we won’t predict what chilly and flu season goes to appear to be this yr, we all know that we’ve to arm healthcare suppliers with the required instruments to rapidly and precisely diagnose the reason for infections in severely sick sufferers, so syndromic testing goes to be essential,” Scott Mendel, GenMark’s CEO, stated in an announcement.
The take a look at, known as ePlex Respiratory Pathogen Panel 2, makes use of a nasopharyngeal swab to gather samples and gives ends in lower than two hours, in accordance 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 Companies. By the contract, BARDA awarded as much as $749,000 to the corporate for the event of the take a look at, the corporate stated in March.
The take a look at was accepted to be used in Europe a few month in the past, the corporate stated. The FDA beforehand approved a GenMark’s diagnostic take a look at for the coronavirus.