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BARDA is partnering with OraSure Technologies Inc. to develop first rapid at-home COVID-19 diagnostic test

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BARDA and OraSure Technology, Inc. are working together on the development of a point-of-care (POC) test for SARS-CoV-2 that could bring testing closer to the patient. OraSure’s rapid, point-of-care test will be available for use both in clinical settings and at home. This test could become the first for use at home in the United States.

No instruments or trained personnel are needed to administer the test or read the results. Test results are available to the user in approximately 20 minutes. Currently there are no rapid POC tests available for large volumes of testing that can be used during times of quarantine and social distancing.

This test is a quick, non-invasive antigen detection test that has the potential to be deployed quickly to and assess symptomatic and asymptomatic acute infections shortly after the patient becomes infected. Availability of a POC test will allow people to be screened and triaged within minutes rather than waiting several days for test results.

This test, which is built on OraSure’s OraQuick platform, will allow healthcare providers and agencies to distribute tests directly to an individual for testing, with the goal of minimizing exposure risks to others and reduce the threat of infecting others. Regardless if a POC or self-administered test, these early results would allow for faster diagnoses to enhance patient and community outcomes and quickly identify patients needing isolation. A rapid test would not only be a major step towards controlling this outbreak, but also benefit in preventing further spread of the virus by those infected.

BARDA’s support for this project include funding of approximately $710,000 of the $1.2 million project costs and technical support in order for OraSure to request Emergency Use Authorization from the U.S. Food and Drug Administration (FDA).

About the Company:

The following information is provided by OraSure 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.

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