FDA Approves Coronavirus Test That Can Provide Results in 45 Minutes

By Published on March 23, 2020

The Food and Drug Administration (FDA) approved the use of a coronavirus test that can detect the virus within 45 minutes, the company that makes the tests announced on Saturday.

The FDA approved the test, created by Cepheid, a California-based medical device company, through Emergency Use Authorization, a process the helps circumvent the lengthy approval process for drugs, medical supplies and diagnostic measures.

Cepheid said that its “point-of-care” test is compatible with 23,000 automated systems it has in hospitals around the world. Five thousand of those are in the United States, the company said in a statement.

“We have developed a test that provides reference lab-quality results in multiple settings where actionable treatment information is needed quickly,” Dr. David Persing, Chief Medical and Technology Officer at Cepheid, said in the statement.

“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.”

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Cepheid said the test will begin shipping out next week.

Dr. Scott Gottlieb, a former FDA commissioner who served in the Trump administration, called the approval a “key milestone” in the coronavirus fight.

Cepheid did not expect the FDA to approve a speedy test until April at the earliest, The New York Times reported on March 3.

The approval comes as health officials in states hardest hit by the coronavirus pandemic are urging that tests be conducted only on health care workers and people in the hospital. The Washington Post reported that officials in California and New York have said that widespread testing will deplete inventories of medical equipment like gloves and masks, which are already in sparse supply.

The number of coronavirus cases has increased significantly over the past week as test kits have been developed and more widely distributed to hospitals and state labs.

As of Saturday, nearly 20,000 Americans have tested positive for COVID-19, the disease caused by the novel coronavirus.

 

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