FDA approves emergency GenMark tests to screen for flu, coronavirus and other viruses

A medical worker samples a nose swab from a student to test for COVID-19 at the Brooklyn Health Medical Alliance Urgent Care pop-up test site on October 8, 2020, as infection rates spike in New York City.

Angela Weiss | AFP | Getty Images

California-based lab testing manufacturer Genmark Diagnostics announced on Thursday that the Food and Drug Administration provided emergency authorization for its rapid molecular testing that could differentiate between more than 20 different viruses and bacteria, including coronoviruses.

Flu and Kovid-19 patients usually develop symptoms early in the virus, which can make this flu season difficult for doctors and nurses to pursue the diagnosis and best treatment for patients. Public health experts say that tests such as Genmark can be helpful in screening for flu, coronaviruses and other pathogens, as well as effectively treating patients with Kovid-19 and influenza.

Gainmark shares traded up around 15%, but gained more than 4% in subsequent trading.

“While we can’t predict what the cold and flu season will look like this year, we know that we have to quickly and properly dispense healthcare providers with the necessary equipment to prevent infection in critically ill patients. “Syndrome testing is going to be critical,” said Scott Mendel, CEO of GenMark, a syndrome test that could be diagnosed.

The test, called Eplex Respiratory Pathogen Panel 2, uses a nasopharyngeal swab to collect samples and provide results in less than two hours, according to the company. It added that the test was funded 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 the company $ 749,000 for the development of the test, the company said in March.

The company said the test was approved for use in Europe about a month ago. The FDA previously authorized Genmark’s clinical trial for coronovirus.


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