In a rapid about-face, a handful of startups that had already rolled out at-home coronavirus test kits or planned to start selling them soon have suspended their efforts. It’s the latest twist in an ongoing situation that has unfolded as tech companies have rushed to fill testing gaps with direct-to-consumer kits — and as regulators have rushed to wrangle them.
Late last week, several startups told STAT they would begin selling at-home coronavirus tests, mailing kits to customers who would then swab their own mouths or throats and place the samples in the mail. Commercial labs would test the samples, and customers would receive results in a few days. Experts warned that the new tests may not meet the Food and Drug Administration’s high standards for traditional approval, however, and cautioned that consumers might not get an accurate result if they didn’t swab deep enough in their nose or throat.
Friday evening, the FDA appeared to confirm those concerns.
“We want to alert the American public that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for Covid-19,” the agency said in a statement, adding that the FDA had begun to see “unauthorized, fraudulent test kits that are being marketed to test for Covid-19 in the home.”
Still, two of the companies — telemedicine startup Nurx and primary care startup Carbon Health — told STAT over the weekend the new statement did not affect their plans because their at-home tests were processed at laboratories compliant with FDA guidelines. For its part, Nurx also noted its test is processed by a lab located in Washington state, which appears to give coronavirus test manufacturers even more flexibility to sell their tests, the company said.
That appeared to comply with earlier guidance from the FDA, which released emergency guidance in February suggesting that labs complying with federal lab standards known as CLIA could start offering coronavirus tests, as long as they applied for emergency authorization within a set window.
But speaking on background Saturday, an FDA spokesperson said the agency’s guidelines specifically exclude at-home tests. And as part of the guidance issued on Tuesday, the agency said at-home tests — including those processed at CLIA-compliant labs — were not approved.
Given that guidance, Nurx and Carbon both announced this week they would temporarily stop distribution of their at-home kits, which Nurx said was the “responsible decision” in a statement shared with STAT. Both companies said no patients had yet received results from their at-home kits.
LetsGetChecked, another startup that planned to roll out an at-home test, said Tuesday it would immediately release its tests to clinicians and health care workers for use in clinics, but wouldn’t proceed with plans to sell them directly to consumers who could test themselves at home.
“As you can imagine, due to the FDA news and the nature of the situation in general, details were in flux with lots of back and forth,” a spokesperson for the company told STAT on Tuesday. LetsGetChecked is still working on eventually making its test available directly to consumers, the spokesperson said.
There remains some confusion about the FDA’s own plans to advance new kinds of coronavirus tests. In a press conference Monday, Deborah Birx, the Trump administration’s coronavirus response coordinator, teased a forthcoming FDA approval for “self-swab” coronavirus test kits. It was unclear, at the time, whether she was referring to at-home tests or tests done at drive-through sites or clinics.
The FDA attempted to clarify those plans on Tuesday, releasing new guidelines which say the agency is exploring approving a simpler kind of nasal swab that would “allow [for] self-collection of specimens at collection sites.”
Those collection sites seem to include drive-through testing facilities and clinics, not people’s homes, which the FDA warned in another part of the guidelines are “not recommended” for coronavirus testing.