CDC’s Coronavirus Diagnostic Test Gets Emergency Clearance

February 5, 2020

The FDA issued an Emergency Use Authorization (EUA) for a diagnostic test for the novel coronavirus (2019-nCoV) linked to the ongoing outbreak that began in Wuhan, China.

The diagnostic test developed by the Center for Disease Control and Prevention’s (CDC) is a reverse transcriptase polymerase chain reaction test that provides presumptive detection of the virus from respiratory secretions, such as nasal or oral swabs.

“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,” said FDA Commissioner Stephen Hahn. 

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