FDA to allow some labs to use coronavirus tests prior to review

The U.S. Food and Drug Administration (FDA) on Saturday said it will allow some ...

- The U.S. Food and Drug Administration on Saturday said it will allow some laboratories to immediately use tests they have developed and validated to achieve more rapid testing capacity for the coronavirus in the country.

“Under this policy, we expect certain laboratories who develop validated tests for coronavirus would begin using them right away prior to FDA review,” Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health, said in a statement. “We just received word that our test has been approved by the FDA. New York State will begin testing immediately at Wadsworth Lab,” the governor said in a statement, referring to the state’s lab in Albany.

The weeks-long struggle to expand local testing has been criticized as an early misstep in the response by U.S. President Donald Trump’s administration to the outbreak.

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