On Jul. 2, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the third diagnostic test for detection and differentiation of the viruses that cause flu and COVID-19 in individuals suspected of COVID-19 by their healthcare provider to the U.S. Centers for Disease Control and Prevention.

The FDA previously issued EUAs to BioFire Diagnostics and QIAGEN for their tests, which include many other respiratory organisms in addition to the viruses that cause flu and COVID-19.