James Boiani Quoted in "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. …

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.