This Aug. 2, 2018, file photo shows the U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md.Jacquelyn Martin/The Associated Press
An innovative coronavirus testing program in the Seattle area – promoted by billionaire Bill Gates and local public health officials as a way of conducting wider surveillance on the invisible spread of the virus – has been ordered by the federal government to stop its work pending additional reviews.
The program involved sending home test kits to both healthy and sick people in the hope of conducting the kind of widespread monitoring that could help communities safely reopen from lockdowns. Researchers and public health authorities already had tested thousands of samples, finding dozens of previously undetected cases.
But the program, a partnership between research groups and the Seattle and King County public health department that had been operating under authorization from the state, was notified this week that it now needs approval directly from the federal government. Officials with the U.S. Food and Drug Administration told the partnership to cease its testing and reporting until the agency grants further approval.
“Please discontinue patient testing and return of diagnostic results to patients until proper authorization is obtained,” the FDA wrote in a memo.
The delay is the latest evidence of how a splintered national effort to develop, distribute and ramp up testing has left federal regulators struggling to keep up. Amid concerns about the reliability of a burgeoning number of coronavirus antibody tests – which check whether someone may have previously had the virus – the FDA responded last week by ordering companies to submit data proving their accuracy.
But the Seattle program does not test for antibodies and has wide backing, from public health leaders to the Fred Hutchinson Cancer Research Center to Mr. Gates, whose foundation has been deeply involved in fighting the pandemic. The Centers for Disease Control and Prevention also provided an in-person technical adviser to the project.
Dr. Eric Topol, director of the Scripps Research Translational Institute, who is not involved in the Seattle group, said it had “emerged as leading lights in this whole COVID-19 crisis.” He said it was “bizarre” that the FDA would halt such a project.
The Seattle partnership that is conducting the testing, the Seattle Coronavirus Assessment Network, said in a statement that it had been in conversation with the FDA about its program for about 10 weeks and submitted data a month ago.
“We are actively working to address their questions,” the group said.
The program has roots in the Seattle Flu Study, which over the fall and winter had collected thousands of samples from people in Washington state who had symptoms of illness. As previously detailed in the New York Times, researchers there had struggled to get government approval to test those old samples for coronavirus and report the results.
By the end of February, those researchers ended up doing some testing anyway, discovered the first case of community transmission in the region and provided key evidence that the virus had likely been circulating for weeks.
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Mr. Gates, the Microsoft co-founder who has committed much of his wealth to global public health issues, has backed the Seattle study. He said in a blog post Tuesday that the program can detect cases and help guide public health responses.
“Not only will it help improve our understanding of the outbreak in Seattle, it will also provide valuable information about the virus for other communities around the world,” Mr. Gates wrote.
An FDA spokesperson said home collection kits raised additional concerns about safety and accuracy that required the agency’s review. The issue in the Seattle case appears to be that the test results are being used not only by researchers for surveillance of the virus in the community but are also being returned to patients to inform them.
The two kinds of testing – surveillance and diagnostic – fall under different FDA standards. In a pure surveillance study, the researchers may keep the results just for themselves. But coronavirus testing has largely revolved around getting results returned to doctors who can share the results with patients.
“We had previously understood that SCAN was being conducted as a surveillance study,” the spokesperson said.
Private companies have also rushed to promote at-home test kits, and the FDA approved the first one available for purchase in April.
Dr. Topol said it would not make sense to have people swab their noses for possible coronavirus and then not give them the results.
“To withhold that information from people is downright absurd,” Dr. Topol said.
At-home testing kits have been touted as a valuable alternative to in-office or drive-thru testing because they do not require a clinician to risk exposure when swabbing a symptomatic patient’s nose. They have also emerged at a time when public health leaders are looking for ways to rapidly expand testing to look for hot spots and trends.
A Harvard Global Health Institute report last week estimated that the United States needed to be conducting at least 900,000 tests daily, but tracking reports indicate the country is doing about one-third that amount.
Dr. Topol said the country probably needed to ramp up to do millions of tests daily. The infrastructure needed for expansive drive-thru testing would be difficult to achieve, he said, and could miss people who do not want to leave their home to drive to a site.
“Home testing is really the only way we can get massive testing in the United States,” he said.
The Seattle testing group said it has been in conversation with the FDA since the beginning of March and initiated the process to obtain federal approval March 23. That process included submitting data from testing so far on April 13.
The group said FDA officials have requested data regarding the program’s use of nasal swabs. Researchers submitted data validating both the safety and reliability of the swabs in home-based collection, they said. They provided studies demonstrating that any coronavirus samples would remain stable for more than a week at the full range of temperatures typical in the Seattle area. They also provided information about internal controls that allow the organization to determine whether a sufficient specimen was collected to guarantee accurate test results.
The testing group said the FDA has also asked for more information about the program’s effort to test people who do not have symptoms.
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