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

October 8, 20200

A medical worker takes a nasal swab sample from a student to test for COVID-19 at the Brooklyn Health Medical Alliance urgent care pop up testing site as infection rates spike on October 8, 2020 in New York City.

Angela Weiss | AFP | Getty Images

California-based lab test manufacturer GenMark Diagnostics announced Thursday that the Food and Drug Administration granted emergency authorization for its rapid molecular test that can distinguish between more than 20 different viruses and bacteria, including the coronavirus.

Flu and Covid-19 patients typically develop similar symptoms early on in the virus, which could make it difficult this flu season for doctors and nurses to diagnose patients and pursue the best treatment. Tests like GenMark’s that are able to simultaneously screen for the flu, the coronavirus and other pathogens could be crucial to helping hospitals effectively treat Covid-19 and influenza patients this winter, public health specialists say.

Shares of Genmark shot up about 15% after the close but pared gains and were up more than 4% in after-hours trading.

“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, said in a statement.

The test, called ePlex Respiratory Pathogen Panel 2, uses a nasopharyngeal swab to collect samples and provides results in less than two hours, according to the company. It added that the test was funded in part by the Biomedical Advanced Research and Development Authority, which is a part of the Department of Health and Human Services. Through the contract, BARDA awarded up to $749,000 to the company for the development of the test, the company said in March.

The test was approved for use in Europe about a month ago, the company said. The FDA previously authorized a GenMark’s diagnostic test for the coronavirus. 

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