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FDA Authorizes Coronavirus Tests in Academic Laboratories Across U.S.

By Mark Prvulovic - Updated Apr 6, 2020 at 8:23AM

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Health authorities are letting more organizations do tests of their own.

The U.S. Food and Drug Administration (FDA) announced on Saturday that it will now allow academic hospital labs across the country to begin testing for COVID-19, with the agency estimating that around 300 to 400 medical centers will be able to start effective immediately.

Before this announcement, the U.S. government's testing capabilities had been relatively limited, with only the Centers for Disease Control and Prevention (CDC) having developed an official test for COVID-19. However, the results have proved to be somewhat unreliable, something which has prompted other groups to try to develop their own tests.

A nurse holding a coronavirus test in her hand.

Image source: Getty Images.

"We believe this policy strikes the right balance during this public-health emergency," said FDA Commissioner Stephen M. Hahn. "We will continue to help to ensure sound science prior to clinical testing and follow-up with the critical independent review from the FDA, while quickly expanding testing capabilities in the U.S." 

Further details

The announcement follows an earlier news conference in which President Trump warned the American public and the press to remain calm as the first U.S. coronavirus death was officially confirmed, involving a Washington state man in his 50s. Health officials along the West Coast are worried that further outbreaks are possible, especially since the woman who died didn't contract COVID-19 from travelling abroad.

Moderna (MRNA -5.06%) and Gilead Sciences (GILD -1.27%) are two biotech stocks developing potential COVID-19 treatments right now. Gilead is using its former Ebola drug, remdesivir, while Moderna has developed a new mRNA-based vaccine. Both treatments have begun human clinical trials.

Mark Prvulovic has no position in any of the stocks mentioned. The Motley Fool owns shares of and recommends Gilead Sciences. The Motley Fool has a disclosure policy.

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