OraSure Technologies, Inc., a leader in point-of-care diagnostic tests and specimen collection devices, today disclosed that the U.S. Food and Drug Administration (FDA) has requested additional information as part of its review of the Company’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 the qualitative detection of total antibodies to SARS-CoV-2 in human oral fluid specimens collected with the OraSure Oral Antibody Collection Device.

At the FDA’s request, the Company intends to resubmit two separate EUAs for the ELISA and the oral specimen collection device. In addition, the FDA has requested that additional analytical studies be conducted on sample collection and stability.

“To date, there are no oral fluid antibody tests for COVID-19 authorized for sale in the U.S. As such, FDA’s guidance on EUA submissions for COVID-19 antibody tests focuses on blood samples for tests; the Agency did not outline specific requirements for an oral fluid test. Consequently, we were unable to completely anticipate all of the data that would be required for a first-of-its-kind oral fluid antibody test,” said OraSure President and CEO Stephen S. Tang, Ph.D. “This request is within the normal course of an FDA review and we are confident that we’ll be able to provide the requested data, and resubmit our EUA application for this pioneering product promptly.”

Antibody tests are well suited for community surveillance and seroprevalence studies to identify people who have antibodies against COVID-19. Oral sample collection is quick, painless, non-invasive, and requires less human contact than a blood draw, minimizing the need for personal protective equipment and reducing exposure to potentially infected patients.

About OraSure Technologies
OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. Together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, CoreBiome (now operating under the Diversigen brand), UrSure, and Novosanis, OraSure provides its customers with end-to-end solutions that encompass tools, services, and diagnostics.

The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities, and direct to consumers.