FDA issues EUA for first 2019 novel coronavirus diagnostic

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Feb. 14, 2020—The FDA issued an emergency use authorization to enable emergency use of the Centers for Disease Control and Prevention’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel. The test provides presumptive detection of 2019-nCoV from respiratory secretions, such as nasal or oral swabs.

“Since this outbreak first emerged, we’ve been working closely with our partners across the U.S government and around the globe to expedite the development and availability of critical medical products to help end this outbreak as quickly as possible,” FDA Commissioner Stephen M. Hahn, MD, said in a statement from the FDA. “Our collaboration with the CDC has been vital to rapidly developing and facilitating access to this diagnostic test.”