BARDA partners with OraSure on rapid at-home COVID-19 test
The Biomedical Advanced Research and Development Authority (BARDA) and Bethlehem, Pennsylvania-based OraSure Technology, Inc. are working together on the development of a rapid point-of-care (POC) test for SARS-CoV-2 that could bring testing closer to the patient.
The test is built on OraSure’s existing OraQuick platform, which is an FDA-approved oral swab in-home test for HIV-1 and HIV-2. Designed for use both in clinical settings and at home, the new test could become the first COVID-19 test for use at home in the United States. Currently there are no rapid POC tests available for large volumes of testing that can be used during times of quarantine and social distancing.
No instruments or trained personnel are needed to administer the test or read the results, which are available to the user in approximately 20 minutes.
This non-invasive antigen detection test has the potential to be deployed quickly and to assess symptomatic and asymptomatic acute infections shortly after a 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.
OraSure's platform would 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. Whether the test is administered at a POC or at home, 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 the outbreak, but also benefit in preventing further spread of the virus by those infected.
BARDA’s support for this project includes funding of approximately $710,000 of the $1.2 million project costs and technical support needed for OraSure to request Emergency Use Authorization from the U.S. Food and Drug Administration (FDA).
Read more: https://www.medicalcountermeasures.gov/newsroom/2020/orasure-diagnostic/