The U.S. Food and Drug Administration announced Saturday that it has approved the use of the first rapid diagnostic test that could detect coronavirus in about 45 minutes.
The authorization was made Friday and tests should begin shipping this week, according to a statement from California-based Cepheid, the company manufacturing the tests.
“During this time of increased demand for hospital services, Clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities,” says Dr. David Persing, MD, Ph.D., chief medical and technology officer at Cepheid.
The test we’re authorizing today will be able to provide test results within hours, rather than days like the existing tests. The company plans to roll it out by Mar. 30–an incredibly rapid timeline for such an effort. @US_FDA @SteveFDA https://t.co/xcy9SPnsoo
— Secretary Alex Azar (@SecAzar) March 21, 2020
He adds, “An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources.”