FDA Authorizes A COVID-19 Test That Will Take Hours, Instead of Days


Lately, there is more than enough bad news to go around, but FDA’s recent Emergency Use Authorization may provide some good. The most recent in a string of FDA Emergency Use Authorizations is for a test that will be able to provide Americans with results within hours, rather than days like the existing tests.

Emergency Use Authorization

According to FDA, it “issued an emergency use authorization to Cepheid for the Xpert Xpress SARS-CoV-2 test for use in high- and moderate-complexity CLIA-certified laboratories as well as in certain patient care settings. The company intends to roll-out availability of its point-of-care testing by March 30.”

Finding Hope

This is promising news considering that one of the best ways so far for stopping the rapid spread of the virus is not only social distancing, but mass testing. This will get us one step closer to providing testing to more individuals and stopping spread.

If you are looking for more information on FDA regulation of COVID-19 test kits, call Bustos Law Group at (832) 592-7851.