Dr. George Rutherford uttered three words after learning thousands of coronavirus home test kits will be available to help curb the spread of the pandemic in the U.S.
“Yes, yes, yes,” Rutherford, a physician who investigates the control of infectious diseases at the University of California at San Francisco, told Fortune of the testing. “Countries like South Korea have done 270,000 coronavirus tests, trying to get this thing under control, and America has done far less than that. We need a lot of tests in many forms, and we need them now.”
With a widespread call across the country for more high-speed COVID-19 testing, help may be on the way as Everlywell, an Austin-based at-home health testing startup, will start selling 30,000 COVID-19 at-home testing kits on Monday.
Initially, the orders will be limited to health care companies from across the country—and from as far away as Africa—to test their workers, who are on the front lines of the coronavirus outbreak. That decision by Everlywell, made late Sunday, came after a flood of requests from hospital systems, doctors, nurses, and health care providers—and a public plea from the White House. For now, the health care companies will pay for the at-home tests and give them to their workers for free.
Sometime in the near future, Everlywell plans to open orders to at-home customers nationwide. But the Food and Drug Administration on Friday blocked at-home test kit sales to consumers, throwing Everlywell’s plan into confusion. The agency said it was working with test kit manufacturers on “expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection.”
In a statement, Everlywell responded, “We are still committed to making a COVID-19 test available to consumers who fall within the CDC’s guidelines for recommended testing and are actively working with the FDA on a path forward.”
Last week, Everlywell CEO Julia Cheek told Fortune about selling tests to healthcare companies: “It has become increasingly apparent there is a desperate need for health care workers caring for sick patients on the front lines to have priority access to testing for COVID-19. There has been a massive concern by these professionals who are being exposed, and could contract the virus, but there aren’t enough tests to see if they have it themselves.”
The coronavirus tests by Everlywell, and soon by rival at-home testing startup Nurx, arrive as the number of coronavirus tests in a country such as South Korea is 40 times as high as that in the U.S., with a population of 330 million people, according to a recent report by Oxford University.
Everlywell’s testing will soon add to the more than 236,000 tests (and counting) conducted in the U.S., according to the COVID Tracking Project. Thousands more tests are supposed to be conducted weekly by federal and state labs, hospitals, and private companies such as Quest Diagnostics and LabCorp, Dr. Deborah Birx, the White House coronavirus response coordinator, and Vice President Mike Pence have told reporters.
The at-home testing in the U.S. also comes as more than 35,000 confirmed cases of the virus have led to more than 400 dead on Monday morning, according to a coronavirus tracker compiled by Johns Hopkins University. As a result, major states including California, New York, and Illinois have ordered all their residents to stay home, meaning about one in three Americans must sequester themselves.
Meanwhile, medical workers across the country continue to face a severe shortage of equipment and supplies, including swabs used for coronavirus testing, masks, surgical gowns, and eyewear to protect them as the pandemic spreads. The coronavirus is three times as contagious as the flu, Pence has said.
Additionally, the at-home testing arrives as the Food and Drug Administration announced this week that it is letting states get their own coronavirus testing systems underway. This measure means that the FDA may allow states to take steps such as permitting the use of new unapproved tests or letting labs not previously authorized to start testing.
“Yes, we fell way, way behind on diagnostic testing due to poor planning and preparation by the Trump administration in particular,” Dr. Donald Berwick, a former administrator of the Centers for Medicare and Medicaid Services under the Obama administration, told Fortune on Thursday. “Now, the shortage of supplies is coming back to haunt us.”
While Rutherford and Berwick both say they are not as familiar with the likes of Everlywell (which has received millions in venture capital funding and was once publicly criticized about its food sensitivity testing) and Nurx, each supports the need for various types of coronavirus testing. Those include at-home and drive-thru testing or tests performed at a hospital or clinic. The doctors both welcome public and private partnerships to get it done.
“It’s crucial to have testing, period,” Berwick said.
Everlywell’s plan is to send its tests, which cost $135 each, overnight to people who either had direct exposure to the coronavirus or are experiencing symptoms. The customers will have to fill out a questionnaire and fall within the Centers for Disease Control’s (CDC) guidelines for recommended testing. If customers meet the criteria, PWNHealth, Everlywell’s telehealth partner, will send them the test.
Everlywell customers must take a nose swab sample themselves and send it to a lab in prepaid packaging. The results could be available online within three days, Cheek said, at which point customers will be given an appointment with a physician from PWNHealth, during which they’ll learn what to do next, especially if they test positive for the virus.
The Trump administration is promoting using telehealth and telemedicine services to increase the chances of seeing a doctor while also lowering the potential risk of infecting others.
Rutherford, the San Francisco–based physician, voiced concerns that at-home testers must be well instructed about how to use a long nasal swab to provide a good lab sample. Failing to do so may result in a false negative.
“This is not just swabbing the first quarter-inch of the nose; you have to dig in there,” Rutherford said. “If you are going to do it, I’d say make sure getting the specimen hurts and your eyes water. Give yourself a thorough swabbing.”
President Trump gave a similar description of his coronavirus-testing experience during a briefing with reporters at the White House on Sunday.
Everlywell has enlisted eight medical labs across the country that will split a $1 million incentive offered by the startup to make the tests a priority, Cheek said. All of the labs comply with the FDA’s Emergency Use Authorization for rapid COVID-19 testing, she added.
Berwick said he hopes the participants act responsibly as this is part of a medical concept called “crisis standards of care,” where, under catastrophic conditions, health care may substantially change or be relaxed due to a scarcity of resources—in this case, the number of coronavirus tests.
“When the demands are overwhelming, crisis standards of care still should not be sloppy or dangerous,” Berwick said. “But we need to be flexible in certain circumstances. We have to do everything we can to intercept this pandemic.”
Julie Khani, president of the American Clinical Laboratory Association (ACLA), a trade group representing medical labs, agrees.
“As scientific advances push forward new tools to meet this need, we must ensure that all results—regardless of specimen type—are backed by good science,” Khani said. “Our ability to make headway against this national emergency depends on it.”
Everlywell hopes to soon ramp up the number of at-home tests to 250,000 a week, said Cheek, who added that her company will make no profit from the tests. “This is going to be a long-term effort,” she said.
Update: This article has been updated with information from the Food and Drug Administration about blocking at-home coronavirus test kits and a comment about that from Everlywell.
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