On Tuesday, the US Food and Drug Administration issued emergency authorization of a diagnostics test for the novel coronavirus that has sickened more than 20,000 people and killed 427 since emerging in China six weeks ago.
The exemption will make the test—which was developed by the US Centers for Disease and Control and until now has been performed only in its laboratories—available to public health labs across the country. The move skirts normal approval channels, signaling the need for speed as the regulatory agency joins the effort to contain the disease’s spread. “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.
In the two weeks since Chinese authorities quarantined 35 million people in the city of Wuhan and surrounding regions, cases have continued to accumulate daily by the thousands. Doctors inside the locked-down area told The New York Times this week that they don’t have enough testing kits to diagnose, let alone treat, the deluge of masked patients lining up outside hospital doors. With cases of person-to-person transmission outside China on the rise, health authorities around the globe are now scrambling to beef up their own diagnostic capabilities.
Thanks to the emergency authorization, the CDC test will now be available to any qualified lab in the world. The health agency has already shipped the test to a repository where states and international partners can order it. But the news is most significant in the US, because it means hospitals and public health departments can now use the test on-site rather than having to ship samples to the CDC. This should help prevent the CDC from getting backlogged should the US experience its own wave of local transmissions.
Today’s emergency authorization is as historic as the outbreak it’s intended to contain. When MERS broke out in Saudi Arabia in June 2012, the FDA didn’t issue its first emergency use authorization for a diagnostic test until the following June. For Zika, it took about seven months after the virus exploded in Brazil. An FDA exemption took about the same amount of time following the devastating Ebola outbreak in West Africa in 2014. The speed with which public health officials are now pushing through a new diagnostic test shows just how seriously they’re taking the potentially pandemic threat of 2019-nCoV. It’s also a sign that the world is starting to learn how to deal with an