Companies are hoping to sell self-administered COVID-19 tests to capitalize on the intense diagnostic demand, but the Food and Drug Administration is poised to crack down on companies marketing the tests, which already were facing questions about accuracy, logistics and costs.
A handful of companies say they are already offering, or plan to launch, kits that allow people to use nasal swabs on themselves and then ship the sample to labs to process the tests.
President Donald Trump last week said the FDA would soon advance policies to promote self-administered tests, but the agency has yet to issue any specific guidance.
Then in a statement on Friday night, the FDA sternly declared that it had authorized no such tests and described any effort to sell them as "fraudulent."
"At this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19," Commissioner Stephen M. Hahn and Judith A. McMeekin, associate commissioner for regulatory affairs, said in a statement.
The statement noted that the FDA hoped to work with developers to authorize this kind of testing but until then, they would issue warning letters and injunctions, or even seize tests, from companies not in compliance.
"The FDA will take appropriate action to protect consumers from bad actors who take advantage of a crisis to deceive the public by marketing tests that pose risks to patient health," said Hahn and McMeekin.
Before Friday, some companies sending out self-swab kits said they didn't believe they would conflict with any existing rules, especially since the FDA was giving a green light to most private developers to deploy tests before any review.
The agency recently eased oversight over test development in a variety of ways to make tests more widely available. That decision could increase the risk of inaccurate tests, health care watchdogs say, and the self-administered tests could increase that likelihood.
Yet even those who typically push for strong FDA oversight acknowledge the agency had to take a calculated risk in order to increase testing availability, which so far has been one of the biggest holes in the country’s coronavirus response.
“We’re behind the curve here and we need to do more testing,” said Michael Carome, director of the health research group at Public Citizen. He said there is a risk that looser FDA oversight, or problems with the logistics of self-administered tests, could result in more false positive or false negative results, which are both problematic.
“Those are the dangers of tests that might not be validated,” he said. But, he added, “at this point because we’re flying so blindly, there is a need to deploy more tests than we currently have.”
Before the FDA announced its crackdown, CQ Roll Call spoke to two companies planning to launch self-administered tests and one that is already operational. Even setting aside the regulatory challenges, issues involving logistics, the supply chain and costs could be a barrier to the approach.
LifeHope Labs in the Atlanta suburbs has been sending out and processing kits since March 9. The company says it is employing physicians who assess potential patients over the phone. If they are approved for a test, the company sends it overnight, and then after self-administering the swab, the customer is supposed to return it overnight in a cold storage package. The lab can process tests in four hours and posts results online.
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Nurx, a San Francisco-based company that normally does telehealth consultations for birth control prescriptions and at-home screenings for sexually transmitted infections, planned to launch a similar service Monday. Customers would send samples to the company’s partner, Molecular Testing Labs of Vancouver, Washington. The company didn't respond to questions about how the FDA's Friday night announcement would affect its planned launch.
Some companies have been confident the FDA won’t stop them from sending out their tests without authorization. Tim Allen, chief operating officer of LifeHope Labs, said the Friday announcement applied to tests purporting to deliver results at home — not a self-administered test. "We feel we are not doing anything that is violating any guidances or the law," he said in a text message Sunday.
LifeHope is using a test that was originally developed by the Centers for Disease Control and Prevention, for which the FDA already granted an emergency authorization. He argued the FDA didn’t have jurisdiction over the administration of a swab and the shipping and handling process.
Chris Hall, senior medical adviser for Nurx, similarly said the partner lab is properly accredited through the Centers for Medicare and Medicaid Services, and that will be the main factor for the FDA.
The risks of self-administered tests not working correctly are not necessarily because the lab test itself wouldn’t work, but because of problems with people trying to swab themselves or problems during the shipping process.
That appears to be the FDA’s concern with a self-test proposed by Irvine, California-based Zymo Research. The FDA told Zymo staff that they would need to conduct studies of whether the self-administered tests are as accurate as tests conducted by a health care worker, according to agency responses provided during the week of March 16 that the company shared with CQ Roll Call.
“There is a substantial public health risk associated with improperly collected specimens because they may lead to false negative results. This risk is significantly higher for specimens collected by a lay user without medical knowledge,” the FDA told Zymo employees.
As Trump said Wednesday, the nasal swab is “not very nice to do.” People administering the tests on themselves would similarly have to insert the swab to an uncomfortable point within a nostril to ensure a sample is collected correctly.
The companies acknowledge this could lead to flawed collection, but each said it would be able to detect when the samples are inadequate to avoid reporting a faulty result. Hall said Nurx would “try to overcommunicate around proper sample collection.”
Another hurdle could be in shipping. Tests would need to be shipped overnight in both directions and kept at cold temperatures to be preserved. People would need to take care not to contaminate the shipping packages, particularly when there is evidence that the novel coronavirus can survive for 24 hours on cardboard surfaces.
If the package and shipping industry begins to be overwhelmed by demand, or its workers become absent due to illness or school and child care closures, the at-home testing initiatives won’t be sustainable, Allen of LifeHope Labs said.
The supply-chain problems that could undercut all COVID-19 testing capacity also apply in this case. The companies acknowledge they can only run tests as long as they have a supply of the chemical reagents that are required for processing. And a shortage of the swabs needed to administer the tests could also cause problems or drive up the costs.
But Hall of Nurx said, “We’re not going to release a kit on our platform that the lab can’t process.”
These companies also say they face a financial quandary. LifeHope charges around $125 before shipping, and Nurx plans to charge cost $135 plus $46 round-trip shipping. Hall noted that the Medicare reimbursement rate announced earlier this month, around $53, “would barely exceed the cost” of round-trip, expedited shipping, and the other companies said shipping costs could be even higher. Private insurance reimbursements are expected to be similar to the Medicare rate.
The three companies said they are not planning to accept insurance and would provide a test only with direct payment. They all said insurance reimbursement is inadequate at this point. “If you’re an independent lab and out of network, try getting paid,” Allen said.
While the three companies interviewed by CQ Roll Call are all labs or are working with labs that are certified under CMS regulations and accredited by the College of American Pathologists, Carome of Public Citizen worries the demand for diagnoses amid the crisis could result in a proliferation of illegitimate companies marketing shady tests.
“It may be difficult for people in the community to recognize whether that is a legitimate company or one of the scammers, and the scammers are going to blossom, I’m sure,” Carome said.