Note: This story has been corrected to clarify that Talis Biomedical did not file for bankruptcy in 2024 but is no longer an operating company. We regret the error.
NEW YORK – After acquiring Lucira Health in a bankruptcy auction in 2023, Pfizer has decided to shut down the business, a Pfizer spokesperson told GenomeWeb.
By the end of the first quarter, Pfizer will stop the manufacturing, sale, and promotion of the Lucira line of molecular COVID-19 and influenza tests, less than two years after the pharmaceutical giant bought Emeryville, California-based Lucira for $36.4 million in April 2023 after Lucira filed for bankruptcy two months earlier.
Lucira received Emergency Use Authorization from the US Food and Drug Administration for the first over-the-counter at-home molecular test to differentiate between SARS-CoV-2 and influenza A and B in February 2023, days after filing for bankruptcy. It first garnered attention when it received the first FDA EUA for an at-home rapid self-test for COVID-19 in November 2020.
In April 2021, Lucira received EUA for over-the-counter use of its Lucira Check It test kit for SARS-CoV-2, and in November 2022 the company received EUA for point-of-care use of its combination COVID-19 and influenza test.
The company's tests used a handheld battery-powered instrument that relies on loop-mediated isothermal amplification to provide results in 30 minutes.
A Pfizer spokesperson said via email that the decision to stop manufacturing the tests called Lucira by Pfizer COVID-19 and Flu tests was "purely a business decision related to the cost associated with these molecular tests."
"Both COVID-19 and flu continue to have significant impact on the well-being of people across the globe, and we remain deeply committed to helping meet this need through vaccines and treatment," the spokesperson added.
Previously known as Diassess, Lucira was founded in 2012 on core technology developed at the University of California, Berkeley, and its scientists worked with a variety of different isothermal nucleic acid amplification methods for instrument-free molecular assays to detect sexually transmitted diseases like chlamydia, as well as influenza.
The company was supported early on by grants from the US National Institutes of Health and contracts with the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority to develop point-of-care and at-home influenza tests.
The firm licensed the LAMP technology used in its SARS-CoV-2 test from Eiken Chemical of Japan and began selling the test and its platform to healthcare providers in 2021 at $1,200 for 24 single-use test units, or $50 per test.
After seeing some success with its technology during the height of the COVID-19 pandemic, Lucira went public in February 2021 in a $153 million initial public offering. The IPO was intended partially to fund its manufacturing at a higher scale, as well as to establish commercial operations such as a sales and marketing team. Its shares began trading at $17 per share and reached as high as $37 per share, and in the first quarter of 2022 the firm posted a profit for the first time as a publicly traded company.
But that success didn't last, similar to many other diagnostic companies who went public during the pandemic and struggled to find their footing after the disease moved to an endemic state and funding for COVID-19 testing dried up. Lucira's shares dropped below $1.00 per share and its expenses piled up as it awaited regulatory approval for its combination COVID-19 and influenza test.
Waiting for that approval was costly, and Lucira President and CEO Erik Engelson said when it filed for bankruptcy that the protracted EUA process led to "high expenditures without new revenue from the combined test kit during the 2022-2023 flu season."
In its Q3 2022 filing with the US Securities and Exchange Commission, Lucira noted that some of the delays were the result of a lack of clinical data. The firm at one point had to amend its application to limit the test to point-of-care use until it could gather additional prospective clinical data.
In October 2022, the firm began implementing cost-reduction plans and layoffs and eventually sought out accounting and consulting firm Armanino to review its strategic options.
Lucira is not the only COVID-19-era company that saw its fortunes fade. Cue Health, another developer of molecular point-of-care and at-home tests, went from a $200 million IPO in 2021 to bankruptcy in May 2024 after multiple rounds of layoffs and cost-reduction plans. Australian firm Ellume, meantime, received EUA in December 2020 for an over-the-counter at-home rapid antigen test for SARS-CoV-2 and filed for bankruptcy in 2022. Talis Biomedical, another point-of-care diagnostic firm that went public in a $254 million IPO in 2021, is no longer a public operating company.
Even larger diagnostic companies that had big COVID-19 testing businesses, such as Abbott, Roche, and QuidelOrtho, have seen the impacts of the shift to an endemic state. Many large diagnostics players no longer break out their COVID-19-related revenues when reporting financial results because they are not material to earnings, and all of them have seen COVID-19 sales fall significantly over the past three years.