FDA issues emergency approval for coronavirus diagnostic test

FDA issues emergency approval for coronavirus diagnostic test
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The Food and Drug Administration issued an expedited approval of a test for the new coronavirus, signing off on its use by state health labs. That should speed up efforts in the US to detect cases of the virus, which has sickened nearly 25,000 people around the world. Until now, all samples from suspected cases in the US had to be sent to the Centers for Disease Control and Prevention for testing.

“The ability to distribute this diagnostic test to qualified labs is a critical step forward in protecting the public health,” said FDA commissioner Stephen Hahn in a statement.

The FDA sidestepped the usual regulatory channels and signed off on the test under an Emergency Use Authorization, which allows the use of medical products in life-threatening situations when no approved alternatives are available. The agency previously issued emergency authorizations for tests for MERS, Ebola, and Zika.

Source: The Verge

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