FDA claims critical milestone in novel coronavirus fight with first emergency use authorization for a diagnostic

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) that will allow use of a Centers for Disease Control and Prevention (CDC) Diagnostic Panel by any CDC-qualified lab in the United States when dealing with cases of the novel coronavirus.

That authorization, according to the FDA, represents a crucial milestone in fighting the spread of the novel coronavirus (2019-nCoV). It will allow CDC’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel to finally break beyond governmental walls and find more extensive use. All experts will need are respiratory secretions, such as from 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,” Dr. Stephen Hahn, FDA Commissioner, said. “Our collaboration with the CDC has been vital to rapidly developing and facilitating access to this diagnostic test. The FDA remains deeply committed to utilizing our regulatory tools and leveraging our technical and scientific expertise to advance the availability of critical medical products to respond to this outbreak in the most expeditious, safe, and effective manner possible.”

The EUA is a direct result of Health and Human Services Secretary Alex Azar’s declaration of a public health emergency due to the novel coronavirus last week. Testing will still be limited, and only meant for those patients meeting CDC criteria for 2019-nCoV testing. There remain no commercially available diagnostic tests for the virus at this time.

Currently, federal health officials continue to state that, despite the declaration, the threat to the general public in the United States remains relatively low.