Benzinga | May 26, 2021 07:22AM EDT

OraSure Says FDA Requested Additional Analytical Data On Sample Collection And Stability And Resubmit Separate EUAs For Antibody ELISA And The Collection Device

Regulation FD Disclosure. OraSure Technologies, Inc. ("OraSure" or the "Company") previously submitted an application to the U.S. Food and Drug Administration ("FDA") for Emergency UseAuthorization ("EUA") for use of the OraSure SARS CoV-2 Antibody ELISA ("Antibody ELISA") in the qualitative detection of total antibodies to SARS CoV-2 in human oralfluid specimens collected with the OraSure Oral Antibody Collection Device ("Collection Device"). After reviewing the Company's submission, the FDA requested that theCompany provide additional analytical data on sample collection and stability and resubmit separate EUAs for the Antibody ELISA and the Collection Device. The Companyhas completed the necessary studies, collected the requested data and, on May 21, 2021, submitted applications for the separate EUAs as requested by the FDA