FDA issues rare comment on approval of Covid and flu home test from company that went bankrupt

Last week, the Food and Drug Administration issued an emergency authorization for the first at-home Covid-19 and flu combination test. The news came just days after the test’s maker, Lucira, filed for bankruptcy, blaming the FDA’s “protracted” approval process for its financial problems.

Now the FDA has released a rare comment clarifying what happened during its authorization process. The new details are raising hopes among other home-test manufacturers that the FDA is becoming more flexible about its requirements for approving at-home flu test kits.

The FDA ultimately authorized Lucira’s test with fewer samples than the agency had previously said it would require for approval, the statement from Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, explained. It accepted fewer samples partly because a National Institutes of Health program gave the FDA data showing that even without more test samples, Lucira’s test kits would be of appropriate quality.

Shuren introduced the comment as “part of the FDA’s commitment to address misinformation.” The agency did not immediately respond to questions about what misinformation the statement was meant to address. The statement also disclosed the FDA initially identified a “toxic substance” in one of Lucira’s test components, which the company rectified with a test redesign.

Lucira declined to comment on the FDA authorization process.

Home-test company executives including Nelson Patterson, president and CEO of Anavasi Diagnostics, and Michael Mina, chief science officer of home testing company eMed, lauded the FDA’s decision to be more flexible in the data it requires for approval.

In a written comment, Mina said the NIH’s Independent Test Assessment Program (ITAP) “is innovative and focuses less on the types of evaluations that FDA usually asks for (clinical specimens from people who do not know if they are infected) and more on efficient formats of evaluating tests.”

But while the FDA’s clarification of what happened with Lucira suggests that it is willing to modernize its criteria for emergency use authorizations, the news may also add to the frustrations of many test manufacturers who complain the FDA is not transparent or consistent about what data are needed for an authorization.

“To me, that [decision] makes sense from an industry standpoint. I applaud that,” said Patterson, whose company received an emergency use authorization for its molecular Covid test in February. He thought that the precedent set by the FDA’s actions in the Lucira case could bode well for future authorizations from other companies. But, he added of the FDA’s altered requirements for approval, “Do I feel cheated? I wish I had known that that would be the standard, because I would have applied last summer.”

Lucira co-founder Debkishore Mitra, who left the company in late 2022, expressed his own frustrations with navigating FDA requirements in a “Lab to Startup” podcast interview released March 7. “We were building the puzzle a little bit,” said Mitra of earlier FDA authorizations, “but this was not a puzzle where all the pieces are fixed graphics and you put them in. The pieces are changing in shape, size, and color while you’re putting the puzzle together. So it’s a very iterative process.”

In response to inquiries about how the bankruptcy affects its operations, Lucira said, “Our focus is making available those tests we have built up in preparation for an authorization prior to the respiratory season.” A Feb. 27 press release says the company is “seeking a strategic or financial partner for the resumption of manufacturing and development of additional home diagnostic products.”

Currently, Lucira’s Covid and flu molecular tests — which perform similarly to a PCR test, but can be done at home — are available to over-the-counter customers at $34.99, nearly half of their $68 list price.