He said the country’s capacity to test is now so limited that only patients who meet narrow criteria can be tested. But as infections spread through communities, broader testing is needed.
“To have that happen, you need the volume, and you need the scale at the lab level,” he said.
Dr. Alexander L. Greninger, an assistant professor at the University of Washington Medical Center in Seattle, the epicenter of the nation’s outbreak, said his lab has already been talking to Roche about expanding its capacity and was obtaining the equipment needed to begin using the commercial test. The Washington lab is testing about 1,500 patients a day, and the Roche approval will significantly expand that.
Dr. Greninger estimated that labs could begin using the Roche tests in about a week.
In an interview, Dr. Thomas Schinecker, chief executive of Roche Diagnostics, said developing such a test normally takes years. Several other testing companies, including Hologic and Cepheid, have also said they were developing commercial tests for the virus.
With the approval, he said, “we can really do a lot more testing in a much shorter period of time.”
The company has been installing new equipment around the country in anticipation of the F.D.A. approval, and Dr. Schinecker said that all of the major American testing companies already have the Roche testing systems.
Under pressure from Gov. Andrew Cuomo of New York, the F.D.A. also on Friday granted New York State’s public health department the authority to allow other labs in the state to conduct tests, without having to go through the federal agency.
The F.D.A. said a 24-hour emergency hotline would be created to help private and academic labs process and validate tests, and President Trump announced that he would hold a 3 p.m. news conference to discuss his administration’s response to the virus.
The news of Roche’s participation came as the Department of Health and Human Services announced it would award over a million dollars to two other companies, DiaSorin Molecular and Qiagen, to speed up the development of one-hour tests. The tests mark a potentially significant overhaul of the current federal diagnostic model, which requires swabs from patients be sent to laboratories for testing. That takes hours at a minimum.