BREAKING: FDA authorizes first rapid ‘point-of-care’ coronavirus test - Washington Post
FDA authorizes first rapid ‘point-of-care’ test for coronavirus
By
Emily Rauhala and
March 21, 2020 at 9:10 a.m. PDT
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8:58 a.m.
The Food and Drug Administration late Friday approved the first coronavirus test that can be conducted entirely at the point of care for a patient — and deliver results in 45 minutes.
The FDA granted “emergency use authorization” to Cepheid, a California company that makes a rapid molecular test for the coronavirus. Getting results in 45 minutes would be far quicker than the current situation in which tests typically are sent to central reference labs that can take days to deliver results.
The FDA authorization covers “patient care settings,” including doctors’ offices, but initially will be used primarily by hospitals and emergency departments, the company said. It added that it doesn’t require a nasal swab; nasal aspirate can be used.
In a video on the company’s website, David Persing, Cepheid’s chief medical and technology officer, said the test will “help alleviate the pressure” that the covid-19 has placed on health-care facilities. The new test, he said, will help doctors quickly decide which treatment is appropriate for which patients.
The test has been designed to operate on the company’s automated GeneXpert Systems. There are about 23,000 of those systems throughout the world, of which 5,000 are in the United States, according to the company.
The firm plans to begin selling the test at the end of the month.
By Laurie McGinley