OraSure’s Ebola Test Upgrade Gains FDA EUA Amid Central Africa Outbreak
Event summary
- OraSure’s OraQuick™ Ebola 2.0 Rapid Antigen Test received FDA Emergency Use Authorization (EUA) on July 21, 2026.
- The second-generation test offers increased sensitivity and automated manufacturing, developed under a BARDA contract in 2022.
- Test detects all four known Ebola viruses: Bundibugyo, Zaire, Sudan, and Taï Forest, with results in 30 minutes.
- Current Ebola outbreak in Central Africa (DRC, Uganda) has prompted WHO to declare a global public health emergency.
The big picture
OraSure’s FDA EUA for its second-generation Ebola test arrives as Central Africa faces a severe outbreak, with the Bundibugyo virus posing unique challenges. The test’s rapid results and expanded detection capabilities could play a critical role in containment efforts, while also reinforcing OraSure’s position in point-of-care diagnostics. The company’s ability to scale production will be key amid heightened global health concerns.
What we're watching
- Outbreak Containment
- How the test’s deployment will impact containment efforts in Central Africa, particularly against the Bundibugyo virus with no approved vaccine.
- Production Scaling
- Whether OraSure can meet demand amid ramping up production for the new test.
- Regulatory Dynamics
- The pace at which other regions may authorize the test, given its EUA status in the U.S.