FDA approves new test that could detect coronavirus in about 45 minutes

National

WASHINGTON, D.C. (WIAT/CNN) — Saturday, the U.S. Food and Drug Administration issued the first rapid diagnostic test that could detect coronavirus in less than an hour.

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.

“Our dedicated team at the FDA has been working nonstop to expedite the review and authorization of novel diagnostics during the COVID-19 public health emergency,” said FDA Commissioner Stephen Hahn, M.D. “Today marks an important step in expanding the availability of testing and, importantly, rapid results. Point-of-care testing means that results are delivered to patients in the patient care settings, like hospitals, urgent care centers and emergency rooms, instead of samples being sent to a laboratory. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.”

The company intends to roll-out availability of its point-of-care testing by March 30.

This story is breaking and will be updated.


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