The U.S. Food and Drug Administration granted an Emergency Use Authorization (EUA) for the LumiraDx SARS-CoV-2 antigen test. This is only the third Covid-19 antigen test granted EUA approval by the FDA, and it showed 97.6% accurate results in under 12 minutes. According to the company, this makes it “the fastest, most sensitive antigen point-of-care test currently commercially available.”
HHS Assistant Secretary for Health and COVID-19 Testing Coordinator Admiral Brett P. Giroir, M.D., stated the “LumiraDx Platform is a novel, flexible, highly scalable and low cost rapid point-of-care test that will significantly contribute to our scaling up and expanding testing platforms for SARS-CoV-2. This technology has…almost everything we hope for in new testing platforms coming to market.”
LumiraDx has been a North Atlantic Capital portfolio company since 2016.