FDA makes rare ‘misinformation’ comment on Lucira’s EUA for its at-home Covid-19 and flu test

The FDA has released a rare comment on what happened during Lucira Health’s EUA filing for the first at-home Covid-19 and flu test as part of the agency’s “commitment to address misinformation,” just weeks after the EUA was authorized and the company filed for Chapter 11 bankruptcy.

The FDA did not spell out exactly what it meant by misinformation and declined to comment. But the statement comes after February tweets from one of Lucira’s co-founders calling out the agency for the length and timing of the EUA clearance, as well as its bankruptcy filing, which said the delay in EUA financially hit the company.

The statement, which was attributed to Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health, said that the agency had found a toxic substance in the test’s first submission that could pose a risk to users.

The FDA allowed Lucira to redesign the test and fix the problem, and also eventually accepted the EUA with fewer samples than it had previously said it would require.

The initial EUA application had only nine positive influenza A clinical samples, which the FDA said wasn’t sufficient. When Lucira resubmitted, the company included 35 samples instead of the requirement of 50.

“In lieu of collecting additional samples, the FDA worked with our partners at the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP) to evaluate the company’s ability to manufacture tests of known quality. This data supported authorization even with the lower than requested number of positive influenza A samples that were provided,” the statement reads.

Since there were not enough cases of influenza B circulating at the time, the FDA used data from the authorization of Lucira’s point-of-care test, which included influenza B samples from previous flu seasons.

The FDA’s statement also made a point of listing ways the agency makes the data and information necessary for an authorization clear to developers, like virtual town halls and public EUA templates.

In Lucira’s SEC filing for bankruptcy, the company referenced the “protracted” EUA process:

The Company anticipated an EUA for an OTC indication on the COVID-19 and Flu test in August 2022, though the FDA’s approval process became protracted, resulting in high expenditures without new revenue from the combined test kit during the 2022-2023 flu season. As such, the Company’s operations were significantly impacted, leading to the Chapter 11 filing and sale process.

John Waldeisen

On Wednesday, one of the co-founders of Lucira, John Waldeisen, called the FDA’s statement “bizarre” on Twitter. Waldeisen also questioned the public disclosure of Lucira’s submission information and whether that was a violation of federal regulations.

“It’s strange that the FDA felt the need to comment at all. Barely any news outlets noted the strange timing of the EUA w/ Lucira’s bankruptcy. Now this PR exacerbates the situation & raises more questions. Also, don’t y’all have better things to be doing?” Waldeisen tweeted.

On Feb. 24, Waldeisen also pointed out the FDA cleared Lucira’s Covid-19 and flu test — 288 days after initial submission. He called the timing “deeply suspicious” as it came after layoffs and a bankruptcy announcement. The FDA approved the test on Feb. 24 and Lucira filed for bankruptcy on Feb. 22 of this year.

“Is the timing of this clearance due to the public scrutiny that comes with the U.S.’s first at-home COVID test going out of business? Yes, I think so,” Waldeisen wrote.

A spokesperson for Lucira declined to comment.

health
devices
authorization
fda