On Friday, the Food and Drug Administration issued an emergency authorization for the first at-home test that can detect flu and Covid-19 — but for the test’s maker, Lucira, the long-anticipated authorization may have taken too long. The company filed for bankruptcy on Feb. 22, directly blaming the “protracted” FDA authorization process for the over-the-counter combination test for its financial troubles.
“This is a major milestone for Lucira Health and for at-home diagnostics, and I can’t thank our employees and partners enough for seeing this through, and of course, for the FDA’s recognition,” said Lucira CEO Erik Engelson in a statement to STAT, making no mention of the company’s bankruptcy. At the time of publication, Lucira had not answered questions about how the bankruptcy affects their ability to manufacture and sell the newly authorized test kit, which can detect influenza A and B.
The timing of the decision is likely to fuel ongoing frustrations among home test manufacturers, some of whom have said that despite the FDA’s outward expression of support for at-home flu diagnostics, actually getting a test authorized is exceedingly difficult. The understaffed agency has struggled to return responses to pre-submissions in a timely fashion, making it even harder for companies to plan clinical trials. The FDA also requires a particular number of positive flu B cases in those trials to authorize a test, even though the virus circulates at extremely low levels in the U.S. and was nearly non-existent this year. Another test manufacturer previously told STAT that the FDA has also strongly suggested to them that they incorporate a method to automatically report positive cases to public health agencies, a significant challenge.
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The agency’s EUA program allowed an easier route for combination SARS-CoV-2 and flu tests to be authorized than for flu-only tests. A Lucira spokesperson said in a statement that a standalone flu diagnostic is “always a possibility on the Lucira testing platform,” but that the company thought it was important to develop a combination test because of the similarities between Covid and flu.
Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement about the “milestone” Lucira authorization that the FDA “strongly supports innovation in test development, and we are eager to continue advancing greater access to at-home infectious disease testing to best support public health needs.”
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The timing of the FDA’s decision has also sparked criticism of the agency’s pace. According to Lucira’s February 24 bankruptcy hearing, the company filed for an EUA in May 2022 and anticipated receiving it in August, well ahead of flu season. This estimate was based on its experience with its EUA submission for its home Covid-19 test. The company did receive interim authorization in Canada in August, but the FDA took until November to recommend Lucira re-submit for a point-of-care approval. That would allow the test to be used at approved clinics, but not at home. The point-of-care authorization was announced the same day STAT published a piece probing why the FDA had not authorized any at-home tests for flu.
Engelson said in the company’s third-quarter earnings call that the FDA would allow Lucira to submit for home use “once additional prospective clinical data has been obtained through ongoing clinical trials.”
Lawyers indicated in Lucira’s February 24 bankruptcy hearing that the company anticipated robust sales of the test kit during Q4 of 2022 and Q1 of 2023 because of reduced Covid precautions, low flu vaccination rates, and discussions with retailers who indicated they would place “substantial orders” once the test kit was authorized. The “unanticipated” length of the authorization process forced Lucira to cut staff twice in the last four months, with notices going out to the company’s remaining 63 employees ahead of the bankruptcy filing.
Lucira co-founder John Waldeisen, who left the company in 2020, accused the FDA on Twitter of “slow-rolling” the submission, and suggested the timing of both the November decision and the latest authorization indicate the FDA is being too reactive.
“Should all innovative [medical] device companies have to announce bankruptcy for their products to be cleared?,” he wrote.
Unlike most home tests, which have limited sensitivity because they detect the amount of virus antigen present in the sample, Lucira’s nucleic acid amplification technology allowed the amount of virus in the sample to be magnified, thus increasing the sensitivity of virus detection, similar to a PCR test. The point-of-care test retails for $99 per test; the price of the home test has not yet been disclosed.
The company’s lawyers indicated in the bankruptcy hearing that Lucira was not able to find anyone willing to buy the company prior to the Chapter 11 filing. With the only authorized flu at-home flu test on the American market, it’s an open question whether the company’s continued operations will allow the company to survive or will entice another party to buy Lucira.