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FDA issues emergency approval for coronavirus diagnostic test

FDA issues emergency approval for coronavirus diagnostic test


Samples no longer have to be sent to the CDC for testing

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Photo by Marijan Murat / DPA / AFP via Getty Images

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.

So far, 260 people have been under investigation for the coronavirus in the United States. Only 11 have been confirmed positive, and 167 have tested negative. The remaining 82 cases are still pending. The test only takes between four and six hours to run, but it can take significantly more time for state health departments to ship samples to the CDC central lab in Atlanta, Georgia. Now, state labs will be able to run the tests themselves, speeding up the process.

The CDC submitted a request for emergency authorization to the FDA on Monday. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, said at that time that the approval would significantly expand the US’s ability to test people suspected of having the virus. She said the CDC had already shipped the test to the International Reagent Resource, the central distributor for diagnostic tests, so it would be available as soon as approval came through.

To start, around 200 test kits will be sent to qualified domestic and international labs, and each kit can run around 700 to 800 coronavirus tests.

Update February 6, 11:05AM ET: Updated with new information from the CDC.