CDC Seeks Emergency Approval of Diagnostic Test from FDA to Detect 2019-nCoV

“Emergency Use Authorization from the FDA would allow states to use the CDC’s test.”


Last week, the U.S. Centers for Disease Control and Prevention (CDC) said it has been seeking special emergency authorization from the Food and Drug Administration (FDA) to allow healthcare professionals to use a CDC-developed diagnostic test to detect the mysterious new coronavirus.

The World Health Organization (WHO) has currently named the new coronavirus “2019-nCoV,” which was first detected in Wuhan, China. The virus has affected five people in the United States so far.

Currently, states, such as California and Arizona, which are suspected to have the cases of 2019-nCoV, have sent samples to the CDC for confirmation. One U.S. resident in Washington State who was suspected to have the infection after visiting Wuhan, the epicenter of the ongoing outbreak.

Chinese health officials have put millions of people on lockdown and shut down public transports in Wuhan and other nearby cities in order to stop the spread and prevent the virus from spreading globally.

CDC spokesperson Benjamin Haynes said, “Emergency Use Authorization from the FDA would allow states to use the CDC’s test.”

The Washington State resident, who has the infection, had close contact with at least 16 people. He is the first person to be diagnosed with 2019-nCoV in the United States. None of the 16 people has shown any signs of the new coronavirus so far, according to public health officials.

On Thursday, the WHO said the officials are not yet declaring the new virus a global health emergency. The Wuhan coronavirus has currently been spreading throughout China and the world. As of January 25, there are 1,354 confirmed cases, with 41 confirmed deaths, across the world.