OraSure Technologies, Inc. ('OraSure' or the 'Company') previously submitted an application to the U.S. Food and Drug Administration ('FDA') for Emergency Use Authorization ('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 oral fluid specimens collected with the OraSure Oral Antibody Collection Device ('Collection Device'). After reviewing the Company's submission, the FDA requested that the Company provide additional analytical data on sample collection and stability and resubmit separate EUAs for the Antibody ELISA and the Collection Device. The Company has completed the necessary studies, collected the requested data and, on May 21, 2021, submitted applications for the separate EUAs as requested by the FDA.
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OraSure Technologies Inc. published this content on 26 May 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 26 May 2021 11:02:04 UTC.
OraSure Technologies, Inc. provides point-of-care and home diagnostic tests, sample management solutions, and microbiome laboratory and analytical services. The Company's product portfolio is divided into diagnostics products and sample management solutions. Its business consists of the development, manufacture, marketing and sale of diagnostic products and specimen collection devices using its technologies, as well as other diagnostic products including immunoassays and other in vitro diagnostic tests that are used on other specimen types. Its diagnostic products include tests for diseases including COVID-19, HIV and Hepatitis C that are performed on a rapid basis at the point of care, and tests for drugs of abuse that are processed in a laboratory. Its business also includes molecular sample management solutions and services that are used by clinical laboratories, direct-to-consumer laboratories, researchers, pharmaceutical companies, and animal health service and product providers.
ORASURE TECHNOLOGIES, INC. 
