NEW YORK – Lucira Health, which broke new ground in 2020 with the first rapid at-home COVID-19 test but filed for bankruptcy this year, said in a recent US Securities and Exchange Commission filing that it has been acquired by Pfizer for $36.4 million through a bankruptcy auction.
According to the SEC document, the asset sale closed on April 20.
The Emeryville, California-based firm filed for bankruptcy on Feb. 22, just two days before receiving US Food and Drug Administration Emergency Use Authorization for the first over-the-counter at-home molecular test to differentiate SARS-CoV-2 and influenza A and B. The firm said in its bankruptcy petition that the business had $146 million in assets and $85 million in debts as of Dec. 31. In the SEC filing, it said Pfizer entered the winning bid in an April 6 auction for Lucira's assets.
Lucira had received the first FDA EUA for an at-home rapid self-test, the Lucira COVID-19 All-in-One Test Kit, in November 2020, and the firm announced in April 2021 that it had nabbed over-the-counter EUA for its Lucira Check It test kit for SARS-CoV-2. The firm's tests use a handheld battery-powered real-time testing instrument with nasal swab samples and loop-mediated isothermal amplification to provide results in 30 minutes.
In November 2022, the FDA granted the firm EUA for point-of-care use of its RT-LAMP-based COVID-19 and flu test. While Lucira posted its first net positive revenues in the first quarter of 2022, it posted losses later in the year and announced plans to lay off 150 of its 225 employees.
The firm was among the companies that emerged in the pandemic only to struggle to keep the lights on as COVID-19 testing volumes plummeted. Industry watchers have predicted a tough road ahead for the COVID-19-focused firms that have not been expanding their menus.
In announcing its Chapter 11 plans, Lucira said a protracted EUA process for its COVID-19 and influenza test had been costly, leading to the bankruptcy filing and sale process. The firm also said in a previous SEC filing that a lack of clinical data had forced it to limit its combination test to point-of-care use until it could obtain more prospective clinical data.
FDA officials responded to the statements about a perceived lengthy EUA process with a statement that the agency had found Lucira's COVID-19 and flu test had contained a toxic substance in one of the test components, making it unsuitable for home use and delaying the EUA process. After the redesign, the EUA request included only nine positive influenza A clinical samples, which was too few to assess the test's performance.