USFDAJul 21, 2026, 04:33 PM
OraSure Technologies Receives FDA EUA for New Ebola Test
AI Summary
OraSure Technologies, Inc. announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its second-generation OraQuick™ Ebola 2.0 Rapid Antigen Test. This improved test, developed in cooperation with BARDA, offers increased sensitivity and new chemistry, detecting all four known Ebola viruses. The company is increasing production to address the current Ebola outbreak in Central Africa, providing a critical diagnostic tool for timely containment efforts.
Key Highlights
- OraSure Technologies received FDA EUA for its second-generation OraQuick™ Ebola 2.0 Rapid Antigen Test.
- The test detects all four known Ebola viruses: Bundibugyo, Zaire, Sudan, and Taï Forest.
- The second-generation test features increased sensitivity, new chemistry, and automated manufacturing.
- Developed in cooperation with BARDA under a contract granted in 2022.
- The company is ramping up production to meet potential demand.
- Results are available directly on the test device in 30 minutes without instruments.
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