On Jul. 6, 2020, the U.S. Food and Drug Administration (FDA) announced it had 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 Centers for Disease Control and Prevention (CDC).

The FDA has 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. These combination tests work by testing a single sample from a patient for multiple respiratory diseases. Tests based on taking just one sample from a patient may help alleviate the need for multiple sample collections, which means less discomfort for the patient with faster and more comprehensive results. The FDA encourages additional developers to work with the FDA on combination tests that may be useful in preserving critical testing resources during the upcoming flu season.

To date, the FDA had authorized 164 tests under EUAs; these include 137 molecular tests, 25 antibody tests, and 2 antigen tests.