OraSure Technologies has received Emergency Use Authorization from the U.S. Food and Drug Administration for its OraQuick Ebola 2.0 Rapid Test Antigen. The single-use qualitative immunoassay detects antigens from all four disease-causing Orthoebolavirus species—Bundibugyo, Zaire, Sudan, and Taï Forest—and delivers results in 30 minutes without instruments, batteries, smartphones, or laboratory analysis. It is the first and only fully authorized rapid antigen test for Ebola detection, and the second-generation version features improved sensitivity, updated chemistry, and an automated manufacturing process. The test was developed in collaboration with the Biomedical Advanced Research and Development Authority under a 2022 contract, and OraSure is scaling up production to meet demand amid the ongoing Ebola outbreak in the Democratic Republic of the Congo and Uganda. OraSure shares closed Tuesday at $3.80, down 1.30%, and were trading up 1.05% at $3.84 in the overnight market.
OraSure Technologies IncFDA granted Emergency Use Authorization for OraQuick Ebola 2.0 test, enabling sales during outbreak.