FDA Authorizes At-Home COVID-19, Flu Test Days After Company Filed For Bankruptcy

The Food and Drug Administration (FDA) has authorized the use of at-home test kits that could detect flu and COVID-19 days after the kit maker filed for bankruptcy.

In a filing with the Securities and Exchange Commission on Feb. 17, Lucira Health said that the long FDA authorization process led to high expenditures without new revenue from its combination test kit for COVID-19 and flu.

The company said in a separate statement on Feb. 22 that it has filed for protection under Chapter 11 of the U.S. Bankruptcy Code in the United States Bankruptcy Court for the District of Delaware. This means the company can reorganize its business while the bankruptcy case is underway.

"The Company further disclosed that it intends to pursue a sale of its business under Section 363 of the Bankruptcy Code, while continuing to support its customers during the Chapter 11 process," Lucira Health wrote.

In a press release on Friday, the FDA finally issued an emergency use authorization (EUA) for the over-the-counter (OTC) at-home diagnostic test.

"Today's authorization of the first OTC test that can detect Influenza A and B, along with SARS-CoV-2, is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home," Jeff Shuren, the director of the FDA's Center for Devices and Radiological Health, said.

"In individuals with symptoms, the Lucira COVID-19 & Flu Home Test correctly identified 99.3% of negative and 90.1% of positive Influenza A samples, 100% of negative and 88.3% of positive COVID-19 samples and 99.9% of negative Influenza B samples," the FDA wrote.

Meanwhile, Lucira Health President and CEO Erik Engelson thanked the FDA for the recognition.

"This is a major milestone for Lucira Health and for at-home diagnostics, and I can't thank our employees and partners enough for seeing this through, and of course, for the FDA's recognition," Engelson told health news outlet STAT.

However, the length of the authorization process, which the company did not anticipate, forced Lucira to cut staff twice in the last four months, with notices going out to the company's remaining 63 employees ahead of the bankruptcy filing, according to the outlet.

"Unfortunately, as restrictions lessened in 2022, we saw lower demand for COVID-19 tests," Engelson said in the company's statement. "This, combined with slower than anticipated regulatory approval for the new combined test kit developed for the 2022-2023 flu season led to insufficient revenue and capitalization to offset expenditures."

"Despite every effort to reduce capital outlays and restructure our business, we took this action to protect and maximize the value of our assets."

The test made by Lucira works by swirling the sample swab in a vial placed in the test unit, according to FDA. In 30 minutes or less, the test unit will display the results showing whether a person is positive or negative for each of the following: Influenza A, Influenza B and COVID-19.