Startups spar with FDA over what constitutes a home coronavirus test

Federal regulators and health tech startups are increasingly at odds over the permissibility of at-home testing for Covid-19, the disease caused by the novel coronavirus.
Two companies told STAT this week that their tests were cleared for patients to take at home — including one that said it has already processed thousands of tests. The companies insist they are permitted to sell the tests because they are ordered by physicians and processed in certified labs. The FDA, however, remains adamant that isn’t the case.
“FDA has not authorized any Covid-19 tests for home use, including home collection. Any tests that are intended to be used completely at home or have a sample collected at home and sent for analysis would need authorization by the agency,” an FDA spokesperson said in a statement this week.

Two of the companies selling tests that let customers collect saliva samples at home are MicroGen DX and Vault Health.* MicroGen DX told STAT it did not require FDA approval for its test — which launched on March 31 and costs $99 — because it uses an accredited lab to process the results, and because all patients do to collect a sample is spit into a cup. Vault Health said its test — which is set to launch on April 13 and will cost $150 — was “provisionally cleared,” requires a clinician’s sign-off, and anyone who takes it must do so with virtual oversight from a practitioner via Zoom. Vault’s test involves having patients spit into a tube.

The companies’ thinking appears similar to the initial arguments from the previous smattering of startups who launched at-home coronavirus tests that used throat and nasal swabs last month — all of whom have now stopped selling the tests. Those companies included telemedicine startup Nurx, primary care company Carbon Health, and at-home testing startups Everlywell and LetsGetChecked. Federal regulators swiftly updated their guidance to clarify that no at-home test for Covid-19 had been approved.

But while those companies keep their plans on hold, Vault Health and MicroGen DX are moving forward with their tests. Executives from both companies said they were initially unclear on how the FDA would regulate their tests. The guidelines for coronavirus testing have shifted rapidly, and in some cases the wording of the rules appear to be in conflict, leading to different interpretations.
In part, the confusion could stem from distinct interpretations of exactly which agency would regulate coronavirus tests that allow people to collect samples on their own. The FDA is asserting that coronavirus tests are regulated as individual diagnostic tests, something it oversees. The manufacturers seem to believe that their tests fall under a different purview regulated by a separate agency, the Centers for Medicare and Medicaid Services. The discord resembles the early market for consumer genetic tests, such as those made by 23andMe a decade ago. In that case, 23andMe’s health-related tests were eventually forced off the market.
“FDA’s position for 30 years has been, ‘We can regulate these tests and there’s some historical reasons we don’t regulate, but we can reach in and regulate if we need to,’” said James Boiani, a member of the law firm Epstein Becker Green who specializes in FDA and CLIA legal and regulatory matters.
“They did reach in with genetic tests and they’re doing the same with the Covid home tests,” he added.

Both companies said that based on their latest interactions with the agency, they felt confident that their tests were green-lit.
“We don’t need FDA approval. We’re a high-complexity lab,” said Rick Martin, the chief executive officer of MicroGen DX, referencing that the company’s tests are processed in a CLIA-certified lab. Martin said his company’s lab had processed 7,000 tests as of April 10.
When pressed about the FDA’s statement that the agency had not approved any coronavirus tests that involve home sample collection, Martin said that didn’t matter because patients were merely spitting into a cup to take the test.
“FDA said no tests had been approved for collection. Well, I don’t care if I get on their approved list,” Martin said, adding, “Once I have a validated test, it’s between a patient and a clinician where they collect the sample.”
Jason Feldman, Vault Health’s chief executive officer, said Vault Health’s medical team was “confident” that there is no difference between being physically present in a clinician’s office for a coronavirus test and collecting a saliva sample at home with a physician’s guidance.
“It’s not an at-home test. It’s a physician ordered, practitioner-monitored, physician-reported test,” Feldman said.
*The test being offered by Vault is developed by Rutgers Clinical Genomics Laboratory.

Startups spar with FDA over what constitutes a home coronavirus test