September 29, 2022 – OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in point-of-care and home diagnostic testing and sample collection technologies, announced today that the Biomedical Advanced Research and Development Authority (BARDA) has issued the Company an $8.6 million contract to develop 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 when compared to the de novo U.S. Food and Drug Administration (FDA) authorized test. OraSure’s OraQuick® Ebola Rapid Antigen test is the only test today with a de novo authorization from the FDA and has been used extensively for Ebola cadaver testing in Africa with results available in 30 minutes.
“We are proud to partner with BARDA to develop a 2nd generation Ebola test and help prevent the spread of a disease which impacts some of our most vulnerable global communities,” said Lisa Nibauer, President of Diagnostics for OraSure Technologies. “Whether it be our response to the HIV epidemic, our work to counter the global COVID-19 pandemic, or this project, OraSure has increasingly partnered with the United States Federal government to counter some of the largest public health challenges we face across the globe.”
OraSure’s current OraQuick® Ebola Rapid Antigen Test is de novo authorized for use with whole blood or cadaveric oral fluid. The test received de novo authorized from the FDA in 2019, making it the first and only rapid antigen test to receive authorization for the detection of Ebola virus.