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

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FILE – In this Wednesday, March 11, 2020 file photo, a technician prepares COVID-19 coronavirus patient samples for testing at a laboratory in New York’s Long Island. Wide scale testing is a critical part of tracking and containing infectious diseases. But the U.S. effort has been plagued by a series of missteps, including accuracy problems with the test kits the CDC sent to other labs and bureaucratic hurdles that slowed the entrance of large, private sector labs. (AP Photo/John Minchillo)

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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