The FDA is pushing back on what it has termed “misinformation” swirling around the emergency use authorization it gave one of Lucira Health’s diagnostic tests late last month.
The company’s COVID-19 & Flu Home Test, as the name suggests, is designed to detect SARS-CoV-2 and influenza A and B in a single nasal swab. The FDA’s authorization made it available without a prescription for at-home use—making it not only the first combination flu and COVID test to receive an EUA for over-the-counter sales, but also the first flu diagnostic ever authorized by the agency for at-home use.
When it announced the regulatory nod at the end of February, however, Lucira wasn’t in a purely celebratory mood. The news came just days after the testmaker had filed for Chapter 11 bankruptcy, and while Lucira expressed its appreciation for the FDA’s “diligent work,” it also seemingly cast some blame on the authorization timeline for its financial troubles.
“We regret that we had no option but to file for Chapter 11 bankruptcy and that this occurred days before we received regulatory authorization,” Erik Engelson, Lucira’s president and CEO, said in the Feb. 27 announcement.
“Unfortunately, we were unable to bridge what became a protracted authorization cycle time within our current capital structure and it remained unclear to us when the regulatory authorization would come through, despite working closely with FDA,” Engelson continued. “The Lucira COVID-19 & Flu Home Test would have been especially useful during the recent, severe respiratory season, and we had produced inventory for an anticipated autumn 2022 launch.”
Less than a week earlier, in a Feb. 22 release announcing its bankruptcy filing, Lucira explained that it had expected the EUA to arrive in August 2022 and began manufacturing the test kits that summer in preparation.
However, the company continued, “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.”
The “sale process” referred to Lucira’s disclosure in the Feb. 22 announcement that it had been exploring a potential sale since October 2022 and, with the approval of the bankruptcy court, was seeking “to complete an expedited sale process.” When it received the EUA the following week, Lucira didn’t mention the outright sale, but noted that it is still “seeking a strategic or financial partner for the resumption of manufacturing and development of additional home diagnostic products.”
In a statement of its own last week, the FDA appeared to take issue with Lucira’s blaming its financial woes on the agency.
After examining the initial EUA application submitted for the combination test, the FDA “determined the test posed a risk to consumers due to a toxic substance identified in one of the test components,” Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said in the March 7 release.
Though Lucira corrected that issue, its original EUA request also included clinical data that fell short of the FDA’s recommendations: The agency had previously suggested that tests like Lucira’s be supported by results spanning 50 influenza A-positive clinical samples, 30 influenza B-positive samples and 50 COVID-positive samples—but the company submitted only nine influenza A-positive samples, according to Shuren, who called the submission “insufficient.”
It wasn’t until the end of 2022 that Lucira submitted a wider range of results, the CDRH director said. The updated submission included 35 samples positive for influenza A, as well as the COVID-positive results the company had previously submitted in its EUA application for a COVID-only test and the influenza B-positive results that had supported a submission for a point-of-care version of the combination test.
And while those data still fell somewhat short of the FDA’s recommendations, Shuren said the agency was ultimately able to extrapolate out from the data—and from the results of the National Institutes of Health’s own independent testing—to conclude that Lucira would be able to “manufacture tests of known quality,” resulting in the EUA about two months after the reworked application was submitted.