Lucira Receives CE Marks for Its COVID-19 Plus Flu and COVID-19 Molecular Tests

Emeryville, Calif.-based Lucira Health’s COVID-19 & Flu and COVID-19 molecular tests have received CE mark certifications, clearing the tests for sale in the EU.

The miniaturized tests use nasal swab samples and run on a palm-sized device with no separate instrument or reader, producing results in 30 minutes.

The nucleic acid amplification tests have a sensitivity and specificity comparable to lab-based polymerase chain reaction assays, the company said.  

Lucira said it plans to make its COVID-19 & Flu test available in the EU in the third quarter of 2022 ahead of the influenza season.