OOn Friday, the Food and Drug Administration issued an emergency authorization for the first home test that can detect flu and Covid-19 — but for the test’s creator, Lucira, the much-anticipated authorization may have taken too long. The company filed for bankruptcy on Feb. 22, directly blaming the financial troubles on the “lengthy” FDA authorization process for the over-the-counter combination test.
“This is an important milestone for Lucira Health and for home diagnostics, and I can’t thank our employees and partners enough for making this a reality, and of course for being recognized by the FDA,” said Lucira CEO Erik Engelson in a statement to STAT, without comment. declare 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 approved test kit, which can detect influenza A and B.
The timing of the decision is likely to lead to continued frustration among home test manufacturers, some of whom have said that despite the FDA’s outward support for home flu diagnostics, getting a test authorized is extremely difficult. The understaffed agency struggles to return timely responses to pre-submissions, making it even more difficult for companies to schedule clinical trials. The FDA also requires a certain number of positive flu B cases in those studies to approve a test, even though the virus is circulating at extremely low levels in the US and has been nearly non-existent this year. Another test manufacturer previously told STAT that the FDA has also strongly advised them to use a method to automatically report positive cases to public health authorities, a significant challenge.
The agency’s EUA program allowed for an easier route for the approval of a combination of SARS-CoV-2 and flu tests than for tests for flu alone. A spokesperson for Lucira said in a statement that a standalone flu diagnosis is “always a possibility on the Lucira testing platform,” but that the company felt 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 on the “milestone” Lucira authorization that the FDA “strongly supports innovation in test development, and we are eager to continue to promote of better access to infectious agents for home use”. disease testing to best support public health needs.”
The timing of the FDA’s decision has also led to criticism of the agency’s pace. According to Lucira’s Feb. 24 bankruptcy hearing, the company filed for an EUA in May 2022 and expected to receive it in August, well before flu season. This estimate was based on his experience with his EUA submission for his Covid-19 home test. The company did receive interim clearance in Canada in August, but it wasn’t until November that the FDA recommended Lucira reapply for point-of-care approval. This would allow the test to be used in approved clinics, but not at home. The point-of-care authorization was announced the same day STAT published a piece examining why the FDA had not authorized home testing for the flu.
Engelson said in the company’s third-quarter earnings call that the FDA would allow Lucira to file for home use “once additional prospective clinical data is obtained through ongoing clinical trials.”
Lawyers indicated during Lucira’s bankruptcy hearing on Feb. 24 that the company expected strong sales of the test kit in Q4 2022 and Q1 2023 due to reduced Covid precautions, low flu vaccination rates and discussions with retailers who indicated they ” substantial orders”. once the test kit was authorized. The “unexpected” length of the authorization process forced Lucira to lay off staff twice in the past four months, with notices given to the company’s remaining 63 employees ahead of its bankruptcy filing.
Lucira co-founder John Waldeisen, who left the company in 2020, blamed the FDA on Twitter of the “slow rolling” of the filing, and suggested that the timing of both the November decision and the latest authorization indicate that the FDA is being too reactive.
“All must be innovative [medical] device companies must declare bankruptcy to release their products?” he wrote.
Unlike most home tests, which have limited sensitivity because they detect the amount of virus antigen in the sample, Lucira’s nucleic acid amplification technology made it possible to increase the amount of virus in the sample, increasing the sensitivity of virus detection, similar to a PCR test . The point-of-care test costs $99 per test; the price of the home test has not yet been announced.
The company’s attorneys indicated during the bankruptcy hearing that Lucira could not find anyone willing to buy the company prior to its Chapter 11 filing. With the only authorized home flu test in the U.S. market, it’s an open question whether the company’s continued operation will allow the company to survive or entice another party to buy Lucira.