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FDA authorizes company for rapid ‘point-of-care’ test for COVID-19

Test can deliver results in 45 minutes, company says

A nurse wearing protective clothing handles a potentially infected coronavirus swab at a drive-by testing center at the University of Washington Medical campus on March 13, 2020 in Seattle, Washington.
A nurse wearing protective clothing handles a potentially infected coronavirus swab at a drive-by testing center at the University of Washington Medical campus on March 13, 2020 in Seattle, Washington. (John Moore/Getty Images North America/Getty Images)

ORLANDO, Fla. – The Food and Drug Administration approved the first coronavirus test that will be tested entirely at the point of care for a patient, according to a news release.

Cepheid, a molecular diagnostics company, announced Saturday that it has received Emergency Use Authorization from the U.S. Food and Drug Administration for Xpert Xpress SARS-CoV-2.

The rapid molecular diagnostic test is able to detect SARS-CoV-2, the virus causing COVID-19.

According to Cepheid, the test is able to deliver results in 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 health-care facilities. 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,” said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid. “By leveraging the design principles of our current Xpert Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted to provide rapid detection of current and potential future variants of SARS-CoV-2, we have developed a test that provides reference lab-quality results in multiple settings where actionable treatment information is needed quickly.”

According to the news release, the tests will begin shipping next week.

“Cepheid currently has nearly 5,000 GeneXpert Systems in the U.S. capable of point-of-care testing and for use in hospitals,” said Cepheid President Warren Kocmond. “Our automated systems do not require users to have specialty training to perform testing — they are capable of running 24/7, with many systems already doing so today.”