Lucira Health files for bankruptcy as it receives EUA for home testing for COVID-19 and flu

Lucira Health filed for Chapter 11 bankruptcy last week as soon as the diagnostics company received emergency use clearance from the FDA for a home combination test for COVID-19 and flu.

In company when filing for bankruptcy, it lists about $146 million in assets and about $85 million in liabilities. Lucira plans to use about $4.5 million in cash to fund operations as it seeks to sell itself.

The company said demand for its home COVID-19 test declined in 2022 and the FDA regulatory process for its combined test took longer than expected.

“We regret that we had no choice but to file for Chapter 11 bankruptcy and that this happened days before we received regulatory approval,” said Eric Engelson, President and CEO Lucira Health. “Unfortunately, we have not been able to overcome what has become a lengthy authorization cycle under our current capital structure and it has remained unclear to us when regulatory approval will be received despite working closely with the FDA. The Lucira COVID-19 & Flu home test should have been particularly helpful during the recent heavy respiratory season and we have stocked up for an expected fall 2022 launch.”

Combined test notes first approval for an over-the-counter and home diagnostic that can detect and differentiate between the viruses that cause influenza and COVID-19. He uses a nasal swab to get results in about 30 minutes.

“Today’s authorization of the first over-the-counter test that can detect influenza A and B, as well as SARS-CoV-2, is a major milestone in enabling consumers to have greater access to diagnostic tests that can be performed entirely at home,” Dr. Jeff Shuren, The director of the FDA’s Center for Devices and Radiological Health said in a statement. “The FDA strongly supports innovation in test development, and we are committed to continuing to expand access to home testing for infectious diseases to best serve public health needs. and reliable tests for the Americans who need them.”

BIG TREND

Lucira, founded in 2013, received emergency use approval for its COVID-19 home test in end of 2020. In October, the company said it would lay off 56 employees, or about a quarter of its workforce.

Many digital health and medical technology companies faced financial difficulties after expanding and raising large amounts of cash in 2021. Another home diagnostics company, Cue Health, recently announced plans to cut 26% of its workforce.