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FDA Issues Emergency Use Authorization for CDC Novel Coronavirus Test

This story has been updated to include comments from a media briefing on Wednesday.

NEW YORK – The US Food and Drug Administration late on Tuesday issued an emergency use authorization for a test from the US Centers for Disease Control and Prevention for the novel coronavirus, 2019-nCoV.

The EUA allows the test to be used at all CDC-qualified labs in the US. CDC submitted the test for EUA to the FDA on Monday after US Secretary of Health and Human Services Alex Azar declared a public health emergency last week.

The test leverages reverse transcriptase PCR methods and provides presumptive detection of 2019-nCoV from respiratory secretions, including nasal or oral swabs. A positive result suggests likely infection with the coronavirus. Negative results, however, do not preclude 2019-nCoV infection, the FDA warned, and such results should not be used as the only basis for treatment or other patient management decisions.

Negative results must also be evaluated along with clinical observations, patient history, and epidemiological information.

Under the EUA, the 2019-nCoV real-time RT-PCR diagnostic panel can be used for patients who meet the CDC criteria for testing for the coronavirus. Only labs that have been designated by the CDC in the US and are certified to perform high-complexity testing can run the CDC test, the FDA said.

"This continues to be an evolving situation and the ability to distribute this diagnostic test to qualified labs is a critical step forward in protecting the public health," FDA Commissioner Stephen Hahn said in a statement. "Our collaboration with the CDC has been vital to rapidly developing and facilitating access to this diagnostic test."

In a media briefing on Wednesday, Director of the National Center for Immunization and Respiratory Diseases Nancy Messonnier said that test kits will ship out today to more than 100 US public health labs.

The CDC will initially distribute 200 test kits to US domestic laboratories and 200 to selected international labs, she said, adding that each test kit will have enough reagents to test about 700 to 800 patients.

Labs will subsequently need to validate the kits according to CLIA guidelines, which is likely to take a few days. Additional test kits are being produced and will be made available for ordering in the future.

"Availability of this test is a starting place for greater commercial availability of diagnostics testing for nCoV," Messonier said.

Along with the CDC, numerous industry players have joined the fray and are developing tests for 2019-nCoV or providing test reagents. 

The FDA has also developed an EUA review template for tests to detect 2019-nCoV — which outlines the data that needs to be developed for a pre-EUA package — and said that it is making the template available to diagnostics developers upon request. As of today, the FDA has also directly contacted 35 diagnostics developers and provided them the template, Rear Admiral and FDA Chief Scientist Denise Hinton said at the briefing.

"The FDA is committed to expediting the development and availability of critical medical products to prevent, diagnose, and treat 2019-nCoV using all applicable regulatory authorities to respond to this outbreak," Hinton said.