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The US Food and Drug Administration announced it has authorized the use of the first rapid diagnostic test that could detect the novel coronavirus in approximately 45 minutes. The authorization was made Friday and tests will begin shipping next 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," said Dr. David Persing, MD, Ph.D., chief medical and technology officer at Cepheid.
"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," Persing added. The announcement of more efficient testing comes as the medical community has been looking to get quicker results to stem the tide of the coronavirus outbreak. Last week, Dr. Rod Hochman, CEO of Providence St. Joseph Health, an organization of 51 hospitals and about 1,000 clinics, described testing capacity in the US as highly deficient. The turnaround time on testing results, he said, had ranged from 24 hours to four days, which he called "unacceptable." If cases of the disease are not identified quickly and community spread continues unchecked, it could soon overwhelm the nation's medical system, just as it did in Wuhan, China, said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine.
Company's Release (March 21, 2020): : http://cepheid.mediaroom.com/2020-03-21-Cepheid-Receives-Emergency-Use-Authorization-from-FDA-for-Rapid-SARS-CoV-2-Test
FDA Letter of approval (March 21, 2020):
