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Trump Administration Moves to Speed Coronavirus Testing Trump Administration Moves to Speed Coronavirus Testing
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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. WASHINGTON — The Trump administration, facing fierce criticism over the failure to test broadly for the coronavirus, on Friday said it would set up drive-through testing, start a website to help Americans find a test, and set up new private partnerships to speed tests to the market.
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. The federal government also approved a commercial test that will allow labs around the country to begin processing as many as 4,000 samples a day, and introduced an emergency hotline for laboratories. The Department of Health and Human Services said new partnerships would develop tests that can detect the virus within an hour.
And the administration announced new partnerships with companies developing tests that can detect the virus within an hour. 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 afternoon, coronavirus infections confirmed by lab tests were approaching 2,000, with 41 deaths, according to a New York Times database. The global death toll neared 5,100.
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 afternoon, coronavirus infections confirmed by lab tests were approaching 1,900, with 41 deaths, according to a New York Times database. The global death toll neared 5,100. The federal government, including the Centers for Disease Control and Prevention and the Food and Drug Administration, have been criticized for a flawed rollout of coronavirus tests, which were delayed following manufacturing problems at the C.D.C. and after lab directors and public health officials said the F.D.A. moved too slowly to allow outside companies and academic labs to develop their own tests.
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. Other countries, such as South Korea, quickly ramped up their testing, screening thousands of people at drive-through sites.
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. On Friday, the Trump administration unveiled a similar plan as the nation’s largest pharmacy chains, including CVS and Walgreens, agreed to move forward with drive-through testing. Pharmacy executives said details are still being finalized, but testing would be done in dedicated spaces outside of a select number of pharmacies by non-pharmacy personnel.
The Trump administration also introduced new tools aimed at helping patients and labs recognize symptoms and troubleshoot testing.
At a White House news conference Friday afternoon where President Trump declared a national emergency, Dr. Deborah L. Birx, the Trump administration’s coronavirus response coordinator, said that a website developed with Google will help Americans access the drive-through clinics. A questionnaire on the website will screen for symptoms and guide people to one of the clinics if needed. Results would then be available within 24 to 36 hours, Dr. Birx said, displaying a large flow chart outlining the process.
“The goal is for individuals to be able to drive up and be swabbed without having to leave your car,” Mr. Trump said, claiming that 1,700 engineers at Google were helping with the website.
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“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. Mr. Trump added that help from private companies would result in five million more tests available by the end of the month.
The nation’s largest pharmacy chains agreed to move forward with drive-thru coronavirus testing, a program instituted successfully in South Korea. Pharmacy executives said details are still being finalized, but testing would be done in dedicated spaces outside of a select number of pharmacies by nonpharmacy personnel. “I doubt we’ll need anywhere near that,” he said.
Moments earlier, Mr. Trump appeared to recognize how dire the need was for testing, saying that people should only get tested with “certain symptoms.” Last week, he promised that “anybody that wants a test can get a test,” a claim that top federal health officials have had to walk back.
“We don’t want people to take a test if we feel that they shouldn’t be doing it,” Mr. Trump said.
The five million number could fall well short of what is actually needed. C.D.C. officials and epidemiologists conferred last month about what might happen if the coronavirus gained a foothold in the United States, and one projection held that between 160 million and 214 million people could be infected. The outbreak could last months or even more than a year, experts said.
The F.D.A. turned to Roche, a Swiss health care giant, to speed 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.
The emergency approval of the Roche test could significantly expand the nation’s capacity for testing. It 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.
A Roche spokesman said some labs could begin testing as early as Saturday, with more getting started next week.
Dr. Birx said that new capacity of the Roche test will help big lab companies like LabCorp and Quest Diagnostics to process the tests that will be used in the drive-through sites. The Roche test, which is automated, “cuts out a lot of the manual pieces that were happening that were delaying the test results,” she said.
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.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.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.“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. 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.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.”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.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.
The F.D.A. said a 24-hour emergency hotline is now available to help public and private labs process and validate tests, staffed by F.D.A. employees who field calls about potential problems with getting controls for tests or with swabs taken from a patient, among other subjects. In the first day that the hotline has been up, the F.D.A. has received dozens of calls, an F.D.A. spokeswoman said.
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. Beyond Roche, the Department of Health and Human Services also 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.
The F.D.A. said a 24-hour emergency hotline is now available to help public and private labs process and validate tests, manned by F.D.A. employees who field calls about potential problems with getting controls for tests or with swabs taken from a patient, among other subjects. In the first day that the hotline has been up, the F.D.A. has received dozens of calls, an F.D.A. spokeswoman said.
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.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.“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. H.H.S. 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 and a close ally of Mr. Azar’s, 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. 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, H.H.S. said.
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.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.”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.“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.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.”“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. Katie Thomas reported from Chicago. Ellen Gabler and Sheri Fink contributed reporting from New York.