Labs across country get OK for coronavirus testing

The Food & Drug Administration on Saturday gave approval for 300 to 400 academic medical center laboratories nationwide to develop tests to identify COVID19, a highly contagious strain of the flu that has sickened more than 85,000 people worldwide and killed one person in Washington state.

The decision vastly increases the nation’s capacity to confirm the presence of the new coronavirus while cutting the time needed to process samples. In making the decision, the FDA waived the requirement that labs first get emergency authorization to do the tests.

Until Saturday, the Centers for Disease Control and Prevention in

Atlanta was among the few places in the country that tested for COVID-19, resulting in turnaround times of a day or two. Now, labs that are certified to perform highcomplexity testing can immediately begin analysis for COVID-19.

“Rapid detection of COVID-19 cases in the U.S. requires wide availability of diagnostic testing to control the emergence of a rapidly spreading, severe illness,” the FDA wrote in announcing the ruling.

COVID-19 “has demonstrated the capability to rapidly spread, leading to significant impact on health care systems and causing societal disruption.”

Allegheny Health Network infectious disease specialist Nitin Bhanot said the system would be looking into conducting its own tests. UPMC officials were not immediately available to comment.

“We do advanced testing, more than what smaller hospitals do,” Dr. Bhanot said. “We’d definitely be interested in exploring the opportunity to test for COVID-19.”

The FDA’s decision came a day after Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, said she planned to have

COVID-19 test kits to every state by the end of the week. Problems were discovered in the kits initially sent out by the CDC.

The fatality rate from the new coronavirus has been estimated at about 2%, but in a New England Journal of Medicine article Friday, Anthony S. Fauci, head of the National Institute of Allergy and Infectious Diseases at the CDC, said the death rate may be “considerably less than 1%” because of the suspected number of cases with mild or no symptoms. The mortality rate for seasonal flu is about 0.2%.