Trump Administration Moves to Speed Coronavirus Testing
The Department of Health and Human Services and the Food and Drug Administration are funding private companies that are rushing faster tests to the market.
A testing station in Denver on Thursday. The Department of Health and Human Services on Thursday morning made drastic changes to the team overseeing the distribution of tests to public and private labs.Credit...Chet Strange for The New York Times
By Noah Weiland and Katie Thomas
· March 13, 2020Updated 12:51 p.m. ET
·
o
o
o
o
o
WASHINGTON — The Trump administration moved on Friday to drastically speed up coronavirus testing, approving a commercial test that will allow labs around the country to begin processing as many as 4,000 samples a day, and introducing an emergency hotline for laboratories.
The Food and Drug Administration enlisted Roche, a Swiss health care giant, in the testing effort, giving the global drug manufacturer emergency permission to sell to labs the first commercially approved test for the coronavirus in the United States. That should help expand the scope and speed of coronavirus screening.
And the administration announced new partnerships with companies developing tests that can detect the virus within an hour.
Combined, the moves signaled the federal government was rushing to catch up with overwhelming demand for more testing capacity, as the number of confirmed coronavirus cases climbed and hospitals began to be stretched thin by surges in patients. As of Friday morning, there were at least 1,739 cases of coronavirus confirmed by lab tests and 41 deaths, according to a New York Times database. The global death toll neared 5,100.
NEW C.D.C. FIGURES
The worst-case estimate for coronavirus deaths in the United States.
The approval of the Roche test means that labs that already have the company’s high-capacity testing equipment — which are available in more than 110 labs in the United States, as well as around the world — will quickly be able to test for the virus. Roche said its commercial test will provide results in three and a half hours. One of its systems, the cobas 8800 System, will be able to test 4,128 samples in 24 hours. Another, the cobas 6800 System, can run 1,440 tests in 24 hours.
The F.D.A. has been criticized by lab directors and public health officials for moving too slowly to allow outside companies and academic labs to develop their own tests for the virus, even as other countries, such as South Korea, have quickly ramped up their testing.
Get an informed guide to the global outbreak with our daily coronavirus newsletter.
“These actions today show our commitment to working around the clock to help expedite the availability of tests,” said Dr. Stephen M. Hahn, the F.D.A. commissioner, in a statement.
Dr. Bala N. Hota, an associate chief medical officer at Rush University in Chicago who is overseeing the hospital system’s response to coronavirus, praised the moves.
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.
Doctors have been clamoring for “point-of-care” coronavirus tests allowing results to be produced where patients are received, similar to how people are tested for the flu or strep throat.
“We are working with the private sector at an urgent pace to make these tests available on as many diagnostic platforms as we can in the coming weeks,” Rick A. Bright, the director of the biomedical research unit at Health and Human Services, said in a statement.
The agency also made drastic changes to the team overseeing the distribution of tests to public and private labs, installing Adm. Brett P. Giroir, the agency’s assistant secretary, to oversee the efforts.
Dr. Hahn of the F.D.A. and Dr. Robert R. Redfield, the director of the Centers for Disease Control and Prevention, now must report to Admiral Giroir, said Alex M. Azar II, the health and human services secretary.
The move was another indication of tension among top health officials as the Trump administration has struggled to catch up to the demand nationally at public health labs. Mr. Azar has privately expressed frustration to Dr. Redfield over the C.D.C.’s slow and faulty rollout of tests in February, which have caused panic among doctors and patients hamstrung by the federal government’s restrictions on who can be tested, and when. State health labs with dwindling testing resources have said they do not have the capacity to conduct tests that have been requested.
A top federal health official said on Thursday that the government’s testing methods so far are “failing.”
“The system does not, is not really geared to what we need right now, to what you are asking for,” Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases, told lawmakers at a House hearing on Capitol Hill.
Dr. Fauci appeared to pin some of the blame on the way that C.D.C. has distributed tests to public health labs, which must receive a request from a physician on behalf of a patient.
“The idea of anybody getting it easily the way people in other countries are doing it, we are not set up for that,” Dr. Fauci said. “Do I think we should be? Yes. But we are not.”
Katie Thomas reported from Chicago.
Coronavirus Testing