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 scholar to test for COVID-19 at the Brooklyn Health Medical Alliance pressing care pop up testing website as an infection charges spike on October 8, 2020 in New York City.

Angela Weiss | AFP | Getty Images

California-based lab test producer GenMark Diagnostics introduced Thursday that the Food and Drug Administration granted emergency authorization for its speedy molecular test that can 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 in the virus, which may make it troublesome this flu season for medical doctors and nurses to diagnose sufferers and pursue the greatest therapy. Tests like GenMark’s that are capable of concurrently display for the flu, the coronavirus and other 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 features and have been up greater than 4% in after-hours buying and selling.

“While we can’t predict what cold and flu season is going to look like this year, we know that we have to arm healthcare providers with the necessary tools to quickly and accurately diagnose the cause of infections in seriously ill patients, so syndromic testing is going to be critical,” Scott Mendel, GenMark’s CEO, mentioned in an announcement.

The test, referred to as ePlex Respiratory Pathogen Panel 2, makes use of a nasopharyngeal swab to gather samples and gives leads to lower than two hours, in keeping with the firm. It added that the test was funded partially by the Biomedical Advanced Research and Development Authority, which is part of the Department of Health and Human Services. Through the contract, BARDA awarded as much as $749,000 to the firm for the growth of the test, the firm mentioned in March.

The test was accredited for use in Europe a few month in the past, the firm mentioned. The FDA beforehand licensed a GenMark’s diagnostic test for the coronavirus. 

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