FDA greenlights first point-of-care, 45-minute coronavirus test
SUNNYVALE, Calif. - The U.S. Food and Drug Administration has authorized its first rapid novel coronavirus test, which will allow those in the medical field to get results for a patient in about 45 minutes.
"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 healthcare facilities,” Cepheid’s chief medical and technology officer, David Persing, said in a statement.
“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.
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The company said it plans to begin shipping the test this week. They are also pursuing its approval in Europe.
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