FDA grants first emergency use authorization for point of care diagnostic

The US Food and Drug Administration on Friday issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test.

The FDA issued an emergency use authorization to American molecular diagnostics 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.

"The test we're authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out by March 30, which is an incredibly rapid timeline for such an effort. With new tools like point-of-care diagnostics, we are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them," said Health and Human Services (HHS) Secretary Alex Azar.