Dive Brief:

• The U.S. Food and Drug Administration has authorized the first over-the-counter at-home test to detect both influenza and COVID-19.
• Lucira Health secured the emergency use authorization after showing the molecular test correctly identified around 90% of positive COVID-19 and influenza samples, and almost 100% of negative samples, in a clinical trial.
• However, the FDA approval came too late for Lucira, which filed for bankruptcy last week after the lengthy authorization process caused it to miss out on combined test sales in the 2022 to 2023 flu season.

Dive Insight:

Lucira was one of the diagnostic companies that rose to prominence during the pandemic. In November 2020, the California-based company received the first EUA for a fully at-home COVID-19 test. Early the following year, Lucira raised $176 million through an initial public offering. As demand for COVID-19 tests waned in 2022, the company worked to get a flu combination test to market by the fall of last year.

On Friday, Lucira received EUA for the at-home test, which uses RT-LAMP technology to detect the RNA of SARS-CoV-2, influenza A and influenza B. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, called the EUA “a major milestone in bringing greater consumer access to diagnostic tests,” adding that the agency “strongly supports innovation in test development.”

But consumer access may take time to achieve, as the FDA review took longer than Lucira had expected. The company submitted the EUA filing in May 2022 and, according to Lucira CEO Erik Engelson, included “all of the clinical data that was previously agreed in a pre-submission with FDA.” Yet the FDA limited the initial EUA, which was awarded in November, to point-of-care use and requested “additional prospective clinical data” from Lucira. 

Crucially, the delay caused the EUA for the at-home test to come after the 2022 to 2023 flu season. In response, Lucira laid off 68% of its staff, took a charge of $107.2 million “due to a significant reduction” in its sales forecast and began a review of strategic alternatives including the sale of the business. Lucira ended September with $39.8 million in cash.

The review of strategic alternatives has yet to find a transaction to save the business, leading Lucira to file for bankruptcy protection last week while it continues to search for a buyer. Robert Eisenbach, from Lucira’s counsel Cooley LLP, told the bankruptcy judge how the company had reached this point, explaining that it expected to receive EUA in August and for retailers to place “substantial orders,” based on its discussions. However, the “approval process unexpectedly became protracted,” according to the company, and Lucira missed the flu season.

Lucira’s shares have lost 99% of their value since the company went public on Feb. 5, 2021, and closed Friday at 14 cents.