As the COVID-19 outbreak worsens in the U.S., at-home test kits for the virus have been a source of both hope and controversy.
Their appeal is clear: sick individuals could get a diagnosis from the comfort of home, without infecting others. But their downsides are real: the U.S. Food and Drug Administration (FDA) has cracked down on unauthorized at-home COVID-19 tests, updating its emergency use authorization guidelines to exclude at-home test kits and warning Americans that no such tests have received agency authorization.
That means startups previously offering these products—such as Everlywell, Nurx and Carbon Health—must now stop. All three confirmed to TIME that they are not currently offering at-home COVID-19 testing, though all stand by the need for it.
If they can convince the FDA, these kits could help shape public perception of at-home medical testing for years to come. COVID-19 has already proven its ability to alter the way American physicians practice, and the way the U.S. government regulates health care. With millions of Americans confined to their homes and unable to see doctors face-to-face, virtual telehealth platforms are surging after years of slow uptake. In response to the COVID-19 emergency, the Centers for Medicare and Medicaid Services has greatly expanded Medicare’s ability to cover these appointments.
Telehealth’s long-overdue renaissance could usher in more widespread comfort with the idea of at-home medical care. Americans have been conditioned to associate care with a doctor’s office, but telemedicine use during the COVID-19 outbreak has begun to chip away at that. As more and more people grow comfortable with getting care on their couches, at-home diagnostics may be next in line for a revolution.
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The at-home testing market now
At-home testing is already established practice for patients with some chronic diseases. Most people with diabetes, for example, are accustomed to self-testing their blood sugar levels.
Direct-to-consumer (DTC) testing has also become big business for companies offering services to those without chronic conditions. Millions of Americans have used 23andMe’s FDA-approved spit tests to get insights about their genetic predispositions to conditions ranging from breast cancer to food sensitivities.
There has also been a proliferation of DTC tests that promise to detect everything from irregular heartbeats and high cholesterol to sexually transmitted diseases and urinary tract infections. These products usually require people to collect their own urine, blood, spit or swab sample, and then mail them to a lab, where they’re processed by a clinician who sends back results or uploads them onto an app. Typically, if results indicate a medical issue, the companies providing these services will then connect customers with a physician to figure out next steps.
Startup Everlywell is a major player in this space, as is the company LetsGetChecked. “Many issues that are coming to the forefront now”—namely getting all Americans access to the tests they need—”are issues we’ve been working to solve for a long time,” says Everlywell CEO Julia Cheek.
But these and others are not without their skeptics.
The pros and cons of at-home tests
The benefits of at-home testing are obvious. It’s convenient, confidential and potentially improves health care for people in areas where access is limited. The COVID-19 outbreak has emphasized those benefits more than ever. Offering accurate, scientifically validated tests at home could ease dangerous burdens on the health care system, including testing shortages. It could also prevent some routine medical care from grinding to a halt, as more and more resources are diverted toward COVID-19 response.
But doctors have their doubts. “A test is only as good as the specimen,” says Dr. Gary LeRoy, president of the American Academy of Family Physicians. But most people are not experienced at collecting test samples, and so are likely to get it wrong, LeRoy says.
“With a poor sample, you’re more likely to get a false positive or a false negative,” LeRoy says, which could be dangerous if it prevents someone who actually needs medical care from seeing a doctor. LeRoy always recommends patients discuss their plans for at-home testing with a physician.
It can also be hard to tell which tests are legitimate, says Dr. Patrice Harris, president of the American Medical Association. Laboratory-developed tests—a designation for diagnostics developed and used by a single laboratory—can often be sold in the U.S. without going through the FDA premarket review process, as long as they come from laboratories that meet certain compliance criteria. Everlywell, LetsGetChecked, Carbon Health and Nurx are not listed in the FDA’s database of agency-approved at-home tests.
The FDA cautions that laboratory-developed tests, despite having gotten increasingly sophisticated and accessible over time, may overpromise and under-deliver, potentially giving customers incorrect results. One infamous example is the disgraced blood-testing company Theranos, which (although not an at-home test) benefited from the “lab-developed test” loophole before being exposed as a scam.
Finally, on paper, at-home tests may seem cheap, but many are not covered by insurance, and so end up costing people more out-of-pocket than traditional lab tests. But a representative for Nurx counters that at-home tests can save patients time and money, by not requiring them to take off work to travel to a doctor’s office.
Will COVID-19 change the way we think about at-home testing?
Clearly, companies have some hurdles to clear before they prove their tests are accurate and trustworthy. But the demand for them is growing, which may push the FDA to adjust the way it examines DTC tests. The market was expected to be worth $350 million this year, and about half of U.S. consumers feel comfortable with this sort of testing, according to 2018 Deloitte research.
Those numbers may trend upward, as COVID-19 drives cultural acceptance of at-home medical care. Peter Foley, CEO of LetsGetChecked, says his company is already seeing a “distinct uptick in demand for services across the board.”
Shortages of testing equipment and protective gear during the COVID-19 outbreak have made home-based diagnostics more appealing, says Dr. Nisha Basu from the primary care startup Firefly Health, because they could help take some pressure off the country’s hospital system at a time when it’s desperately needed. Both patients who may have COVID-19, and those who need routine testing done during the outbreak, could benefit from at-home care. Social distancing required by the outbreak has also made people reconsider which aspects of health care truly require traveling to an office, lab, or care center, and which can just be handled from home, via a call or video visit.
“It’s going to be a different world that we emerge into as a society,” LeRoy says. “A lot of things we’ve slow-walked because we didn’t see the need for it, such as telemedicine, [will become important].”
Harris agrees that scientifically sound DTC tests can be “a piece of the puzzle,” though there will always be aspects of care that require in-person appointments. It’s hard to know, Harris says, how common they’ll become once the coronavirus outbreak ends, but she says all signs suggest remote health care innovations will continue.
“There may be a time,” she says, “when [every] person has a stethoscope at home.”
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Contributor: Jamie Ducharme