The Chicago Entrepreneur

Lucira Health files for FDA authorization of first COVID-19 & flu at-home molecular test

Lucira Health Inc. said Thursday it has filed for Food and Drug Administration authorization for its first-of-its-kind COVID-19 & flu at-home molecular test. The medical tech company, which went public in February of 2021, specializes in single-use test kits for respiratory diseases. “The request is for prescription at-home use of the PCR-quality test for those with suspected COVID-19 or Influenza,” the company said in a statement. The company is hoping to get authorized ahead of the fall and winter, when COVID and flu viruses are expected to circulate at the same time. The company was first to win FDA authorization for an at-home COVID test in November of 2020. The new test uses the same platform and palm-sized device design and can independently test for COVID-19, Flu A, and Flu B from a single nasal swab with results within 30 minutes. Shares were not yet active premarket, but have fallen 71% in the year to date, while the S&P 500 has fallen 17%.

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