(Update: After this story was published, the U.S. Food and Drug Administration issued a warning that at-home coronavirus tests are unauthorized. Read story here.)
With delays in testing hampering the country’s ability to accurately track the new coronavirus and shelter-in-place orders keeping many Americans at home, startups are swooping in with a seemingly ideal solution: at-home tests.
Over the next week, at least four startups are launching the first at-home tests for Covid-19. The companies, whose tests have been mostly greenlit — but not approved in the conventional sense — by the U.S. Food and Drug Administration under new guidelines instituted for the coronavirus crisis, aim for their diagnostics to offer some certainty to people who have up until now been unable to get tested as a result of the shortage of test kits. Most of the companies have put their other efforts on hold to focus on coronavirus.
“We are pivoting from our prior service lines to make this available,” Chris Hall, senior clinical advisor to San Francisco-based telehealth startup Nurx, told STAT. “It’s a heavy lift, but we think it’s important.”
Outside experts caution that the at-home tests are a piecemeal solution to the country’s failure to test early and widely for Covid-19. The US currently lags far behind every other country with a high proportion of coronavirus cases.
“It’s better than nothing, for sure,” Eric Topol, director of the Scripps Translational Science Institute, told STAT. “But we’re two months late. It’s a small attempt to help a little bit. It’s not worthless, but it’s so little, so late, it’s embarrassing.”
There are also concerns that the tests, which customers will be able to order online for between $150 to $200, may not meet the FDA’s high standards for traditional approval. Coronavirus testing is a delicate task. It’s crucial not only to test people at the right time, but also to get the sample from the right place in the nose or throat. There are also worries that supply chain shortages could stymie efforts to distribute the tests at scale.
Usually, the FDA requires evidence showing how people may respond to test results before it allows them to be sent to people. The agency also typically “takes a good hard look at the information sent to the consumer,” said Hank Greely, director of the Stanford Center for Law and the Biosciences and the Stanford Program in Neuroscience and Society. “I suspect it hasn’t done that here for lack of time.”
Startup executives and medical directors, however, said their tests have gone through all of the required steps to make them ready for consumers. They hope the tests can help alleviate the anxieties of the worried well and keep them out of health care facilities already crippled with coronavirus-related demand.
“It’s a nice way to tell people: Stay away from your local health clinic until it’s safe to come out,” Caesar Djavaherian, the co-founder and medical director of primary care startup Carbon Health, told STAT.
Why startups jumped into at-home testing
Several startup executives — many of whom are also clinicians — said their desire to create an at-home test was influenced by early challenges diagnosing their own patients whom they suspected of having Covid-19. In the early days of the U.S. outbreak, for example, doctors at one of Djavaherian’s Carbon Health clinics in Mountain View, Calif., saw a patient with coronavirus symptoms who’d recently returned from travel to Wuhan, China, where the pandemic began. The patient had wanted to be tested for Covid-19, but Carbon had to turn her away because at the time, she didn’t meet the stringent CDC test criteria.
“We don’t know what happened to her,” Djavaherian said. “We hope she got tested and ended up being negative.”
Since then, Carbon Health has diagnosed a total of 10 positive cases of the virus using its traditional in-clinic tests. For the past few weeks, the company has been sharply focused on creating an at-home test.
The United States remains the furthest behind on testing of any comparable country in the world, according to a regularly-updated data visualization from the New York Times.
For all their weaknesses, at-home tests may still help some people, such as younger patients with milder symptoms, who might either visit a hospital or continue to spread the virus without knowing they have it. Of particular concern to Djavaherian are younger people who live with or care for older people, who are particularly vulnerable to dying from the virus.
“You might not be sick enough to go to the ER, you might not have severe shortness of breath, but you have cold and flu symptoms and you live with your mom who’s 75 and has heart problems. And you know that if you have it, there’s a chance you could kill her,” Djavaherian said. “You might be in your 20s. You won’t die from this. It’s the impact on your family — that’s what we’re trying to lessen.”
Carbon’s test will cost $167.50 and be available as early as this Friday.
Concerns with at-home tests
There remain some important concerns about how well the tests will work, according to Topol and Greely.
Timing, for example, is key: Someone who takes a test too early may later come down with Covid-19 but wrongly believe they are free from the virus, something also known as a false-negative. That person might be more likely to go out and socialize, unknowingly infecting others.
LetsGetChecked’s test, which can ship to patients in two to three days, will take as long as a week to deliver results to patients, said Robert Mordkin, U.S. medical director for LetsGetChecked. The tests being offered by Nurx and Carbon are faster. Both aim to use express shipping services, such as those provided by a courier service or FedEx, to get test kits to customers the day they’re ordered. Both companies said they’d deliver results within three days.
Topol believes that’s too much time to waste.
“This 24-48 hours window is, to me, unacceptable,” Topol said. “In that time, the person doesn’t know whether they should be hunkering down or doing something else. Or let’s say you’ve had contact with a known person. You’re sleepless, you’re high-anxiety, how long do you have to live with that?”
Taking an at-home test presents other problems as well. For an accurate test, a patient must swab deep in the back of the nose or throat where the virus is most active. Similar to a test that’s taken too early, a swab that’s done too shallowly could wrongly convince someone that they don’t have Covid-19.
“It’s not a very comfortable thing, if you do it right. It can feel like you’re trying to gag yourself.” Topol said. “So the chance of false-negatives is high.”
Nurx’s Hall said that’s an issue it planned for, however. After first considering a nasal swab, the company switched to an oral one that he said is easier to use. Nurx’s test does not have approval under the FDA’s emergency rules, Hall said, but instead meets the agency’s latest standards for Covid-19 tests, which simply require compliance with the government’s basic requirements for federal clinical labs, also known as CLIA. It will cost less than $200, Hall said.
There is one final hiccup to the at-home test process, according to Greely: People getting a test result at home may react in unexpected ways compared with how they might handle the news were a clinician delivering it in-person.
“If consumers using [these] tests get positive results, what will they do?” said Greely. “Rush to an ER? Rush to a doctor’s office? Sink into depression? If they test negative, will they stop all precautions, forgetting that the result is a snapshot in time and that they can still get infected? If the test results suggest things for them to do, will they take the advice?”
At present, the startups have a patchwork of ways to deliver the results. Some, like Everlywell, whose test is also not technically FDA-approved and costs $135, require a clinician’s sign-off to ship the test. Others, such as Nurx, pair their results with educational materials about quarantine procedures and social distancing.
Shortages of testing materials
Basic manufacturing and shipping concerns could also hamper efforts to make at-home tests widely available. Shortages of basic ingredients like swabs and reagents, key for jumpstarting the chemical reactions necessary for the tests to work, are already affecting some startups, including Nurx. Even large pharmaceutical companies including Roche and Thermo Fisher, which recently had their in-clinic tests approved by the FDA, have been forced to reckon with supply chain issues that have limited their distribution.
“The concerns about the supply chain are real concerns,” said LetsGetChecked’s Mordkin. “It’s really about what the supply chain will be able to manage, and we don’t know what that number is, quite frankly.”
LetsGetChecked and some other startups are ordering the test components from a supplier and self-assembling the kits. Others, like Everlywell, Carbon, and Nurx, are working with a partner company that handles both the components and the assembly.
“There are significant supply chain issues that relate to swab availability, and we’re dealing right now with an inability to assemble as many kits as we would like,” Nurx’s Hall said.
Regardless of the challenges, the startup executives remain optimistic. While Nurx aims to have 10,000 tests available as early as Friday, Everlywell plans to launch 30,000 tests on Monday. Carbon and LetsGetChecked did not respond immediately to questions about how many tests they aimed to ship.
“We think there’s a chance we’ll have some days where our supply is limited, but we’re hopeful that we’ll at least be able to test some people every day,” said Djavaherian.