Even though the federal government has reassured the public that millions of tests for the coronavirus are on the way, many private laboratories in the U.S. still aren’t able to conduct their own tests, in part because of a demanding government approval process, leading lab experts and industry groups say.
One hospital lab says it could have performed thousands of tests by now. The delays — which have also been driven by a shortage of materials and lack of information from the federal government about how much labs will be reimbursed — have prolonged waiting times to diagnose infected patients while the virus has spread further, according to lab directors and public health experts.
Private labs have been in touch with the Department of Health and Human Services since mid-January about developing their own tests, according to the American Clinical Laboratory Association, which represents commercial and hospital labs. But the federal government didn’t issue new rules speeding the approval process for commercial, research and academic labs until Feb. 29.
Even after that, however, private labs have continued to face hurdles. It could take weeks for some laboratories to get up and running, said Mark Birenbaum, administrator of the National Independent Laboratory Association, which represents labs in smaller cities and rural areas.
“Our labs want to do the testing — the testing is needed,” Birenbaum said. “But we’ve been waiting to get the OK to either create the tests or buy them from test kit manufacturers. It will still take time.”
Some labs have spent weeks developing their own tests but remain frustrated with a federal approval process they say is too time-consuming and expensive.
“I could have tested over 1,000 patients by now instead of checking boxes,” said Dr. Melissa Miller, director of the Clinical Microbiology Laboratory at UNC Medical Center in North Carolina. Miller says her lab had developed a test based on the World Health Organization’s protocol before the state lab even had its own. But the UNC lab hasn’t begun testing patients, as it is still in the process of meeting the requirements for expedited authorization by the Food and Drug Administration, which must sign off on all new tests.
“The necessary validations for the emergency authorization are time- and cost-prohibitive,” Miller said. “We are way behind.”
The FDA says that its requirements help to ensure that tests are based on “sound science” before they reach patients and that it is working closely with companies and labs that are developing diagnostic tests.
Several versions of a test are in use in the U.S., including the one developed by the Centers for Disease Control and Prevention. The CDC has made its test available to qualified laboratories, but some private labs lack the equipment to run it, Birenbaum said.
Until recent days, the vast majority of tests were being conducted by the CDC or public health labs, which have limited capacities. On Monday, CDC Director Robert Redfield said about 4,900 people had been tested by government labs. But there still aren’t enough tests to meet demand in many parts of the country, local officials and public health experts say. (South Korea, by comparison, says it has tested more than 200,000 people since early January, with the capacity to test 15,000 people a day.)
That’s why it’s so critical for private labs to ramp up quickly, said Dr. John Glenn Morris, director of the Emerging Pathogens Institute at the University of Florida.
“The solution is not counting the number of test kits that CDC is distributing — it’s getting the large commercial companies on board so that we can really start testing everybody that comes in,” Morris said. “That’s when we’re going to start discovering how prevalent the virus is.”
In the past week, Quest and LabCorp — two of the country’s biggest clinical testing providers — began rolling out their own commercial tests to doctors and medical providers. But results typically take three to four days from the time specimens are picked up, the companies said.
Quest warned that “timing may be impacted by high demand” and that it would take weeks to ramp up testing. “We expect to be able to perform tens of thousands of tests a week within the next six weeks,” the company said in a statement.
The turnaround is usually far quicker for smaller private labs and academic labs, because the testing is conducted on site instead of shipped to a central facility. Several private labs said they would be able to produce results within four hours once they were cleared to begin testing.
Quick turnaround is critical to slowing the virus, as an infected person may expose others before getting results back.
“The risk is for further spread,” said Dr. Christina Wojewoda, a pathologist at the University of Vermont Medical Center. “There are people who are positive and don’t know they are positive, and they aren’t staying away from elderly patients and those who are immunocompromised.”
So far, the FDA has received requests from 14 private labs for expedited authorization, and 10 of them have begun patient testing, according to a spokesperson for the FDA. Many more labs and diagnostic device companies haven’t even gotten to the point of requesting authorization because they are still developing their tests and trying to meet the FDA’s requirements, industry representatives and lab experts said.
“We are talking to them around the clock, and our door is open for any developers who want to have a test for use in the U.S.,” FDA Commissioner Stephen Hahn said Saturday.
Wojewoda believes the FDA’s requirements are important for ensuring accurate tests.
“The hoops to jump through to do the testing are important to put out correct patient results,” she said. But she added that state health officials are eager to get other labs online and “have us take some of that testing burden off them.”
The University of Vermont Medical Center hasn’t developed a test in-house and doesn’t have the equipment to run the CDC’s test. So it is waiting for commercial manufacturers to develop a test that its lab can use, Wojewoda said. And getting the test isn’t the end of the process. “When we get it into the lab, we need to make sure it works in our hands,” she said, noting that the validation process could take another week to complete.
One of the diagnostic tests the FDA is reviewing is made by Thermo Fisher, a major testing manufacturer. It would cut processing time to four hours, said Ron O’Brien, a spokesman for the company. However, FDA approval could still take weeks, O’Brien said.
The Trump administration has said coronavirus testing would be covered by Medicare and Medicaid, as well as certain private insurance plans. But the government has left it up to local contractors to determine what some of the reimbursement rates will be, which could keep some private labs on the sidelines, said Birenbaum, of the National Independent Laboratory Association.
“We’ve had a lot of issues with payments not covering the cost of the tests,” Birenbaum said. “For our labs, it’s a big investment to gear up for this. We’re going to need to know if it’s at least going to cover costs.”
Other delays have bogged down laboratories.
An academic research institute in New Jersey spent weeks developing a test that it says will produce results within four hours. Hackensack Meridian Health said in a statement that the in-house test will drastically reduce its turnaround time, as it consults with the state Health Department and then sends results to a state lab, which can take one to two days.
But the lab couldn’t secure materials needed to validate the test for FDA authorization until the end of last week, said David Perlin, chief scientific officer for the Center for Discovery and Innovation at Hackensack Meridian Health, which is part of a health care network with 17 hospitals and 500 patient care facilities in New Jersey.
“It shouldn’t have taken this long,” Perlin said. He added that while the lab’s staff was “clamoring” for the genetic material necessary to validate the test, “the CDC didn’t have vendors ready.” (The CDC didn’t respond to a request for comment.)
The lab is completing its application for FDA authorization and expects its test to be ready within days. But had the lab received the needed material sooner, “we would have been ready weeks ago,” he said.
Health and Human Services Secretary Alex Azar denied that there has been any shortage. “We have always been able to meet the full demand for test orders from public health officials,” Azar said during a public appearance Tuesday.
“At no point has a request for a test from a state or local public health department been denied by CDC, and at all times CDC has had capacity to run these tests, either itself or through other CDC public health reference labs,” Azar said, adding that 1.1 million tests had been shipped to public and private labs by the end of last week and that 4 million tests would be produced by the end of this week.
For weeks, however, highly restrictive CDC testing criteria prevented wide-scale national testing, sidelining private labs while the virus continued to spread undetected in communities throughout the U.S. The CDC’s own test had technical errors that delayed its rollout, and the agency was slow to allow public health labs to do testing on their own.
State and local officials from New York to Washington state say the testing delays have kept public health authorities from knowing the full scale of the epidemic, undermining the government’s response, Seattle Mayor Jenny Durkan said.
“We have been so hampered by the early errors around testing in our state we did not see the spread of this disease, and now we’re dealing with that,” she said.
The private lab industry is pushing for the FDA to help get more labs online to fill the critical need for broader testing.
“We urge the administration to take immediate steps to approve emergency use authorizations for as many test platforms and instruments as possible in order to provide swift and accelerated access to diagnostic tests,” said Julie Khani, president of the American Clinical Laboratory Association.
Dr. Luciana Borio, who was director for medical and biodefense preparedness policy at the National Security Council from 2017 to 2019, said that there has been progress in recent days in distributing diagnostic tests and that commercial firms are now actively engaged. But she said crucial time had been lost in fighting the spread of the epidemic.
“I think it’s dreadful that we are in this situation,” Borio said.