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Lucira Health Nabs CE Mark for COVID-19, COVID/Flu Molecular Tests

NEW YORK – Lucira Health announced on Monday that both its COVID-19 and combination COVID-19 and influenza A/B molecular tests have received CE marking.

Both nucleic acid amplification tests run on Lucira's portable device, which has no separate instrument or reader, and return results from a nasal swab in 30 minutes. The COVID-19-only test is currently available in the US, Canada, Singapore, Israel, and Taiwan. It received Emergency Use Authorization from the US Food and Drug Administration in November 2020 for prescription home use and in CLIA-waived settings and got EUA for over-the-counter use in April 2021. 

The Emeryville, California-based company plans to make the combo test available in the EU beginning in the third quarter of 2022, before the Northern Hemisphere's influenza season. Submissions to other regulatory agencies, including the FDA and Health Canada, are planned for Q2, and decisions are expected before the upcoming flu season, Lucira said in a statement.