Elliott Millenson has been here before.
In 1987, his testing company approached the U.S. Food and Drug Administration for approval of an at-home test for HIV. An ensuing swirl of politics fed by fears that the results could be used to discriminate against gay men caught him off guard and delayed approval of his modified mail-in test for nine years.
The infectious coronavirus that causes COVID-19 has a vastly different transmission pattern, risk profile, and political tenor. But the tough lessons learned during the height of the HIV epidemic have only solidified Millenson’s conviction that at-home tests will be critical for preventing new cases and controlling a terrifying outbreak.
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“Americans want to get tested,” said Millenson, founder and CEO of the Johnson & Johnson subsidiary Direct Access Diagnostics, which won FDA approval for its HIV test kit in 1996. “To me, the most important thing is making testing accessible. And part of that is you want a highly accurate test that people can trust.”
This time, he’s far from alone in pushing for a user-friendly, at-home testing alternative to ramp up availability. Amid a surge of activity in recent days, no fewer than a dozen at-home tests for COVID-19 are being developed, and two have now received FDA emergency use authorization. Several outside experts said that if properly regulated, the expanding roster could help plug a huge hole in the nation’s testing capacity.
But given early and well-documented testing woes across America, how big of a deal is at-home testing tech on its own?
“It definitely expands the testing capacity. It gives people the option to have access to testing that they may not otherwise have,” said Dr. Krutika Kuppalli, an infectious disease physician in Palo Alto, California, and vice chair of the global health committee for the Infectious Diseases Society of America.
Kuppalli cautioned, though, that test developers must help educate the public on how to properly collect their own samples, especially if the method involves a nasal swab. “Your test is only as good as your sample,” she said. “Whenever somebody does a test at home, there’s always some room for error.”
When a test is scaled up for tens of millions of people, even small errors can create big problems. “So you want to make the test as foolproof as possible,” Millenson said.
Kuppalli also worried about the lag time between mailing in a test and receiving the results—a period that may run several days—and the potential for individuals whose condition is worsening to delay needed care in the interim. “I think you need to have a very clear message that, OK, you can do the test and you can send it in. But, if you’re getting worse, you need to go and seek medical care,” she said.
But a proliferation of at-home kits could help overcome several other major obstacles to more widespread COVID-19 testing in the U.S. For starters, allowing patients to collect their own samples by spitting into a vial or swabbing their nose would reduce the risk of exposing health-care workers to the coronavirus during the in-person testing process. Sending kits to individual homes could also increase access in underserved communities and among people who may have difficulty reaching a testing site because they’re fearful, sick, or lack transportation.
Cynthia Liu, manager of scientific information for CAS, a division of the American Chemical Society, said the eventual development of an easy-to-use at-home COVID test akin to a pregnancy test, in which the appearance of a band signifies a positive result within minutes, would be huge. We’re not quite there yet. “They need to be cheaper, they need to be convenient to operate, and ideally, the results should come out relatively fast,” Liu said. She and colleagues recently published a survey explaining the various techniques underlying the COVID-19 diagnostic tests in use or in development.
Millenson warned, though, that the FDA must learn from the recent antibody testing debacle in which tests designed to indicate past exposure to the coronavirus flooded the market even though many were never validated (the agency has since beefed up its oversight). “It’s most dangerous on an antibody test to falsely tell somebody that they’re positive,” he said, since it can mislead people into thinking they are immune (even if they are positive, they may not be). The reverse is true for diagnostic tests, in which a false negative result could put unknowingly infected patients—and their contacts—in danger.
If at-home tests are validated for accuracy and can be manufactured cheaply, broad distribution could help states more readily identify viral transmission and move faster to trace potential contacts and isolate active cases to help break the transmission chain. The overall strategy demonstrated its value in controlling COVID-19 in Shenzhen, China, according to a recent study.
So far, the FDA has granted emergency use authorization to two at-home options: a swab-based test called Pixel, developed by Burlington, North Carolina, testing giant LabCorp, and a saliva-based test developed by Rutgers Clinical Genomics Laboratory in Piscataway, New Jersey.
Both tests require users to mail in the samples for lab processing, and both look for viral-specific RNA as a telltale sign of COVID-19. The Rutgers test developers have cited a turnaround time of about two days and the same accuracy as results from a more invasive nasopharyngeal swab. The LabCorp test’s expected turnaround time is one to two days after the sample has been received by the lab.
A recent shift in FDA guidelines may permit more at-home tests by relaxing the requirements around self-swabbing and mailing in samples for processing. In a statement to The New York Times, FDA Commissioner Stephen Hahn lauded the move as a way to cut red tape and increase testing availability.
In addition to those from LabCorp and Rutgers, a recent article by the Kaiser Family Foundation listed another nine at-home diagnostic test kits in the pipeline or available under specific circumstances. Of the test developers who have revealed a price tag, the cost ranges from $99 to $181.
As another promising step forward, Linda Carter—a scientific information specialist at CAS and co-author of the recent testing report with Liu—pointed to recent FDA approval of a so-called antigen test, developed by the Quidel Corporation in Athens, Ohio. Instead of detecting viral RNA, the antigen test rapidly detects protein fragments in the outer capsule that protects the coronavirus. Although not technically an at-home test, Carter said the nasal swab-based antigen test or ones like it could eventually lead to at-home sampling options because the samples can be sent to labs and processed on widely available equipment.
While all of the current tests have potential, they suffer from various weaknesses. One of the biggest is the current price point. “The cost of these tests is just way too high,” Millenson said. “What you want is a low-cost, easy to use, highly accurate test. And what we have are expensive tests that are hard to obtain, and that’s a problem.”
That may be changing. Several additional tests in the works, including a one-step nasal swab or saliva-based test being developed by researchers at MIT and the Broad Institute in Cambridge, Massachusetts, and another genetic test under development by a team overseen by biotech entrepreneur Jonathan Rothberg, are aiming for tests that could be used at home or at work for a cost of $10 or less.
The step forward comes amid increasingly mixed messaging from the White House after a barrage of criticism over its missteps in presenting a coherent testing strategy. Millenson pointed out that health officials initially told many people they didn’t need to get tested, in part because there weren’t enough tests to go around.
During a Monday briefing, President Trump said, “If people want to get tested, they get tested.” He later added, “But for the most part, they shouldn’t want to get tested. There’s no reason. They feel good, they don’t have sniffles, they don’t have sore throats. They don’t have any problem.”
The statement ignored both the fact of asymptomatic White House staff getting tested daily and the conclusion of multiple studies, some by the CDC itself, suggesting asymptomatic and presymptomatic people can carry and transmit the coronavirus.
That consensus, in fact, has only added to the push for at-home testing alternatives given the possibility that symptom-free patients could transmit the virus to health-care workers during in-person testing, or to coworkers or customers in a business setting. “If we had wide availability of the [at-home] test kits, that would help identify those people,” Liu said. “It will help the community; it will help contain the virus.”
Given the stakes, Millerson has been drawn back into developing his own at-home test for COVID-19, as CEO of newly formed Global Diagnostic Systems in Potomac, Maryland. “If you had the perfect test, what would it be? And that’s what I’m trying to develop,” he said. “It would be a highly accurate, easy to use, low-cost test.”
He and other experts say no single company can produce the number of tests that will be needed. “I think there’s room for lots of players, but I think the players should have tests that meet certain threshold standards,” Millenson said. “I think that can be accomplished and I think the manufacturing issues can be overcome. I mean, this is a national priority.”
Or at least it would be, if scientists had their way.
