On Dec. 21, 2020, OraSure Technologies disclosed that the FDA had requested additional information as part of its review of the Companyﾒs application for Emergency Use Authorization (EUA) for its laboratory-based oral fluid SARS-CoV-2 antibody test.

The OraSure SARS-CoV-2 Antibody ELISA is intended for qualitative detection of total antibodies to SARS-CoV-2 in human oral fluid specimens collected with the OraSure Oral Antibody Collection Device.