The U.S. Food and Drug Administration abruptly shut down sales of at-home coronavirus test kits earlier this month but some companies say they haven’t given up.
The scarcity of tests in general, coupled with consumers' desire to take control, makes the idea both intriguing and controversial.
Critics say home tests may be unreliable, might delay necessary treatment and could soak up scarce resources. Proponents say at-home test kits could save money and resources – and in the near future could play a critical role in tracking COVID-19.
The FDA leaped into action on March 20 when several startup companies started selling or preparing to sell at-home kits.
Everlywell had announced plans to eventually test a quarter of a million people weekly with “physician-approved lab tests, fast and easy-to-read results, all from the comfort of your home.” Others, like Nurx, already were selling kits.
In strong language, the agency called at-home test kits “fraudulent.”
“Fraudulent health claims, tests, and products can pose serious health risks. They may keep some patients from seeking care or delay necessary medical treatment,” the FDA said in a public statement.
Julia Cheek, the founder of Everlywell, gained fame in 2017 from pitching her company on the ABC reality-TV show Shark Tank, receiving a pledge for a $1 million line of credit. Everlywell sells a variety of at-home test kits, some of which have been criticized by physician groups.
Cheek rejected the suggestion that her at-home coronavirus tests were fraudulent. She told USA TODAY that she was working with qualified laboratories with a special emergency waiver from the FDA to use unapproved tests.
However, the FDA said it has not approved any tests kits that allow consumers to collect their own samples at home. Dr. Deborah Birx, coordinator of the White House Coronavirus Task Force, reiterated last week that the FDA has approved swabs patients can use themselves under supervision at drive-through centers, but no at-home swabs.
Testing technology is evolving so rapidly that new, quicker tests outside of the home could eventually take over the market. Late last week, the FDA gave the green light to a new test by Abbott Laboratories, in which a portable unit would provide results in minutes. The company says it has begun sending out 150,000 test kits to hospitals and academic laboratories and soon could ramp up to a million tests a week.
Three of the companies that planned to sell the at-home kits got more bad news last week when two members of the House Oversight Committee – Reps. Raja Krishnamoorthi, D-Illinois, and Katie Porter, D-California – sent letters asking if they had refunded consumers and destroyed any samples. They also asked whether the companies were willing to donate their increasingly scarce special swabs for FDA-approved tests.
The companies they targeted were Everlywell, Nurx and Carbon Health.
For all three companies, the kits themselves were simply nasal or cheek swabs with written instructions. They had made a connection to laboratories to test the samples and arranged for overnight shipping. A telemedicine doctor would screen consumers and give advice if the test came back positive.
Nurx told USA TODAY that it had refunded money to 181 buyers. Everlywell decided instead to sell its kits to hospitals and health care providers, where the swabs will be administered by medical professionals. It expects to ship out thousands of these kits.
Carbon Health stopped distributing kits and said it had contacted the 50 patients that had kits to schedule expedited testing at its clinics – none had received their results. Carbon will refund $167 for its tests if they were not covered by insurance.
Coronavirus tests still developing
Despite the intense blowback, companies remain committed to selling at-home kits – if they can get the FDA’s blessing. So far, the agency has said that at-home test kits are not allowed under emergency use waivers, a stance it would have to reverse to clear the way.
“We stand by, ready to help however called upon, and we will continue to explore ways to be supportive in the meantime,” said Nurx spokeswoman Allison Hoffman.
Companies with a stake are not the only proponents of at-home test kits. In a recent commentary on JAMA Health Forum, Dr. Shantanu Nundy – chief medical officer at the health benefits company Accolade Health – advocated for research to determine whether at-home test kits could be effective for COVID-19.
“There are several benefits to a self-service model, including wider availability with lower costs and mitigated risk of exposure to the virus,” he wrote.
An analysis of 14 studies published in September found that self-administered influenza tests that came back positive matched the results tests done by health care workers 87% of the time. The authors of that analysis said that self-administered tests shouldn’t replace clinical testing but could be valuable for surveillance and research.
One of the co-authors of that analysis, Sheena Sullivan, said testing at home could protect health care workers but might also endanger patients who are severely ill by delaying care. Sullivan, an epidemiologist at the University of California Los Angeles, also warned that self-swabbing is not as accurate and is more likely to give a false negative.
One advocate for at-home test kits is billionaire philanthropist Bill Gates, who says data are key to combating the virus. Gates is helping fund the Seattle Coronavirus Assessment Network, or SCAN, through Gates Ventures. The network is a collaboration among Seattle; King County, Washington; and the Seattle Flu Study.
SCAN has received approval for at-home test kits from the Washington Department of Health. But in response to questions, a spokesman said SCAN is not a clinical service. It is a research initiative to better understand the spread of novel coronavirus. It takes samples from people for this research.
Still, Gates said in a recent TED Talks interview that he expects government websites soon to screen patients for coronavirus exposure and send those who meet criteria to kiosks, where they would swab their own nostrils under supervision.
That would relieve the need for scarce personal protective equipment and take the strain off of medical workers. He predicted this eventually could be done at home, and that within six months there might be at-home tests that would provide immediate results.
Sheldon Campbell, a Yale University associate professor and director of clinical laboratories for the VA Connecticut Healthcare System, said at-home nasal screening “seems like a somewhat dangerous idea for several reasons.”
For one thing, Campbell said, a patient’s complex medical history is key to understanding test results. The at-home kits rely on remote doctors to interpret the results and advise the patient. Patients who have the virus still can test negative, so any course of action should take into account the patient’s entire condition.
“I think there is a big difference between a doctor who knows you and a doctor who is operating from a script,” Campbell said.
Campbell added that the delay in receiving the test in the mail and getting back results could be critical if the patient needs quicker attention. And he is concerned that at-home tests could waste scare resources in a healthcare crisis.
“Even the swabs are hard to get,” he said. “If a home system is sending swabs to people, every one that doesn’t get sent back has gone to waste.”
While many of the at-home tests rely on nasal swabs, some use a drop of blood on a cartridge scanned by a smartphone to rapidly test for antibodies against the virus.
That’s the route taken by Scanwell, a startup seeking emergency approval from the FDA to roll out a test already being used in China. Similar technology was just purchased by the United Kingdom to provide 7 million people with testing kits.
Scanwell would charge customers $70 to receive a kit overnight that can then deliver results in minutes – just enough to cover its cost, according to Jack Jeng, chief medical officer. He said the company could be ready to deliver the kits to hard-hit areas in about six weeks.
'All of the above' coronavirus testing needed
New York-based medical startup Radish Health announced this week it had suspended sales of at-home COVID-19 tests in the wake of the FDA crackdown. Although not technically a lab or kit provider, the company had posted a guide for its existing patients to swab their noses and test while quarantined.
They said the company would pick up the swab, take it to a partner lab and get results within 24 to 36 hours. Profits from the $100 test were to be donated to vaccine research, the company said.
Radish founder Viral Patel said the nation needs an “all of the above” model to improve the availability of coronavirus testing. Patel said regulators are stifling testing just as the nation needs it most.
“The problem here is the federal government had a really botched rollout of testing in general," Patel said, "which is why you ended up with a bunch of commercial labs and then startups that are direct to consumer labs being in this state."
“We should have never gotten to this space.”
Everlywell, however, has not given up. The company said scarcity issues are being worked out with the federal COVID-19 task force and emphasized that the doctors who would order tests and review results for the company would be licensed to practice medicine in the state where the customer lives.
The company sells a range of at-home tests, including some that have come under fire. Physician groups, including the American Academy of Asthma, Allergy and Immunology, recommend not using the food sensitivity test Everlywell promotes in commercials. The group says there is no scientific evidence that the test is valid.
Everlywell said the same test is used by physicians and it provides the test at a lower cost, $159. The company claims there is evidence in medical literature to support the test’s validity but didn’t offer any citations.
In earlier interviews posted on the web, Cheek said the company had held back at first with coronavirus.
“For several weeks, we didn’t feel it was either appropriate or necessary to divert our resources to trying to solve this problem,” she said.
But when the FDA called for laboratories to apply for waivers to perform their own unapproved tests on an emergency basis, Cheek changed her mind. Everlywell quickly came up with a plan to sell at-home kits at cost.
Initially, Cheek said the tests would cost $75, with most of that going to overnight shipping. The price rose to $135 over time, which the company says would still provide no profit; it simply realized after talking to laboratories that it would cost more than originally thought.
David Heath and Nick Penzenstadler are reporters on the USA TODAY national investigations team. Contact David at email@example.com or @davidhth, or on Signal at (240) 630-1962 and Nick at firstname.lastname@example.org or @npenzenstadler, or on Signal at (720) 507-5273.