Advisory Board March 1, 2023
COVID-19 and the flu have many overlapping symptoms. But FDA on Friday issued an emergency use authorization for the first at-home test that can indicate whether someone has COVID-19, influenza A, or influenza B, marking a “major milestone” for home-based diagnostics.
FDA issues EUA for the first at-home test for COVID-19 and flu
The newly authorized test is manufactured by Lucira Health — a California-based company that announced its bankruptcy plan last week, citing delays in the test’s EUA, which was filed in May 2022 and initially expected in August ahead of the 2022-2023 flu season.
According to FDA, the single-use test uses a self-collected nasal swab and produces a result within 30 minutes, indicating whether a person is positive...
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