LumiraDx’s COVID-19 Antigen Test Expands Indication to Asymptomatic People

The FDA has granted an expanded Emergency Use Authorization for LumiraDx’s COVID-19 antigen test to include testing of asymptomatic people.

In asymptomatic individuals, the 12-minute test was 82.1 percent agreement on positive results and 100 percent agreement on negative results, when compared with results from a laboratory polymerase chain-reaction test, according to the UK-based company

LumiraDx said it has the manufacturing capacity to “enable rapid, high-sensitivity mass screening programs” in schools, events, travel and other settings.