US FDA authorizes 1st faster, point-of-care coronavirus test

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

"The test we're authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests," said Secretary of Health and Human Services Alex Azar.

Media reports said the test developed by the molecular diagnostics company Cepheid based in California is expected to shorten the coronavirus detection time to about 45 minutes.

The company intends to make its point-of-care testing available by March 30, according to the FDA.

"With the development of point-of-care diagnostics, Americans who need tests will be able to get results faster than ever before. More and more options for reliable, convenient testing are becoming available at an incredibly rapid pace," Azar said.

FDA Commissioner Stephen Hahn said it marks an important step in expanding the availability of testing and, importantly, rapid results.

Point-of-care testing means that results are delivered to patients in the patient care settings, like hospitals, urgent care centers and emergency rooms, instead of having samples sent to a laboratory, according to Hahn.

The number of COVID-19 cases in the United States topped 33,276 as of 21:00 Eastern Standard Time Sunday, with 417 deaths, showed data by the Center for Systems Science and Engineering at Johns Hopkins University.