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FDA authorizes first at-home flu-COVID-19 combination test days after its developer files for bankruptcy

February 27, 2023

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.”

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