LumiraDx Gains CE Mark for COVID-19 Test

London-based LumiraDx has earned CE mark certification for its RNA STAR Complete COVID-19 test.

The assay, for which the FDA granted Emergency Use Authorization in October, is intended to support rapid testing programs in full-scale laboratories and mobile lab units.

The RNA test uses a direct amplification method that combines cell breakdown and amplification in a single step, detecting viral nucleic acid in 20 minutes or less on common polymerase chain reaction systems, the company said.