Tuesday, December 7

FDA Grants Emergency Clearance for GenMark Test That Screens for The Flu, Coronavirus And Other Viruses

KEY POINTS

  • California-based lab test producer GenMark Diagnostics revealed Thursday that the FDA approved emergency permission for its quick molecular test.
  • The test at the same time searches for more than 20 different viruses and bacteria consisting of the coronavirus.
  • Influenza and Covid-19 patients usually establish similar early signs, which might make it tough this influenza season for physicians and nurses to diagnose clients and pursue the finest treatment.

California-based laboratory test maker GenMark Diagnostics revealed Thursday that the Fda approved emergency situation permission for its quick molecular test that can differentiate between more than 20 various viruses and bacteria, including the coronavirus.

Influenza and Covid-19 patients usually develop similar signs early on in the virus, which might make it challenging this influenza season for physicians and nurses to identify clients and pursue the best treatment. Tests like GenMark’s that are able to simultaneously screen for influenza, the coronavirus, and other pathogens could be essential to assisting healthcare facilities efficiently deal with Covid-19 and influenza patients this winter season, public health experts 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 influenza season is going to appear like this year, we know that we need to equip health care companies with the required tools to quickly and accurately diagnose the cause of infections in seriously ill clients, so syndromic testing is going to be vital,” Scott Mendel, GenMark’s CEO, said in a declaration.

The test, called ePlex Respiratory Pathogen Panel 2, uses a nasopharyngeal swab to gather samples and supplies outcomes in less than 2 hours, according to the company. It included that the test was funded in part by the Biomedical Advanced Research Study and Advancement Authority, which belongs to the Department of Health and Human Being Services. Through the contract, BARDA awarded up to $749,000 to the business for the advancement of the test, the company stated in March.

The test was approved for use in Europe about a month earlier, the business stated. The FDA previously authorized a GenMark’s diagnostic test for the coronavirus.