On Mar. 8, 2023, QuidelOrtho announced that it had been granted a De Novo request from the U.S. Food and Drug Administration, allowing the company to market its Sofiaﾮ 2 SARS Antigen+ FIA. The Sofia 2 SARS Antigen+ FIA is the first rapid antigen test that detects COVID-19 to be awarded FDA market clearance. The test is intended for prescription use only and can be used in point-of-care settings.