- The Biomedical Advanced Research and Development Authority (BARDA) has issued an $8.6 million contract to OraSure Technologies Inc OSUR for developing a 2nd generation Ebola test on the OraQuick testing platform.
- The goal is for the 2nd generation test to have improved sensitivity, increased shelf life, new chemistry, and more automation compared to the de novo FDA-authorized test.
- Also see: FDA To Review Smaller Number Of Emergency Use Requests For COVID-19 Tests.
- OraSure’s OraQuick Ebola Rapid Antigen test is the only test with a de novo authorization from the FDA. It has been used extensively for Ebola cadaver testing in Africa, with results available in 30 minutes.
- OraSure’s current OraQuick Ebola Rapid Antigen Test is de novo authorized to use whole blood or cadaveric oral fluid. The test received de novo authorization from the FDA in 2019, making it the first and only rapid antigen test to receive authorization for detecting the Ebola virus.
- Price Action: OSUR shares are up 5.19% at $3.85 on the last check Wednesday.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.