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Latest BARDA collaboration with OraSure Technologies Inc. aims to develop highly reliable, high-throughput diagnostic test for SARS-CoV-2 antibodies in oral fluids

BARDA Response

BARDA and OraSure Technology, Inc. are partnering again, this time on development of an in vitro (laboratory) diagnostic to detect antibodies for the SARS-CoV-2 virus in oral fluids. Currently there are no SARS-CoV-2 antibody tests based on oral fluids available for high-throughput ELISA screening.

Although the test could be used at point of care facilities such as doctors’ offices, clinics, or hospitals, the goal is to have patients collect their own saliva samples at home to maintain social distancing and then ship their sample to the lab. Oral fluid collection is non-invasive and requires less human contact in comparison to blood draw. At-home self-collection also minimizes health care workers’ exposure to potentially infected patients and permits a large number of individuals to be screened quickly.

OraSure plans to leverage the 510(k) cleared Drugs of Abuse (DOA) ELISA platform as the starting point to develop this ELISA-based coronavirus antibody test. The test is being designed to run on automated ELISA instruments, such as Hamilton and Dynex instruments. Development includes a version of the test to detect human anti-Nucleocapsid protein (NP) and/or human anti-Spike 1 (S1) total antibody for the screening of acute infection in a symptomatic population.

Both human anti-NP and anti-S1 IgM and IgG antibodies have been reported to rise in COVID-19 patients within days after the onset of symptoms. With BARDA support, OraSure expects to request FDA’s Emergency Use Authorization from the U.S. Food and Drug Administration within the next five months or sooner. If the EUA is granted, usability and flex studies will be conducted to support self-collection use of the device for home collections and the company will submit data as an amendment to the EUA.

This award is one component of BARDA’s rapidly expanding COVID-19 medical countermeasure portfolio; visit BARDA’s COVID-19 Portfolio to learn more.

About the Company:
The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products.

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, CoreBiome, Diversigen 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. For more information on OraSure Technologies, please visit www.orasure.com.

Last Updated: June 10, 2020

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