OraSure Receives Emergency Use Authorization for Second Generation Ebola Test

What the report says

GlobeNewswire reported that OraSure Technologies said it received Emergency Use Authorization from the U.S. Food and Drug Administration for its second-generation OraQuick Ebola 2.0 Rapid Antigen Test. The Bethlehem, Pennsylvania-based diagnostics company announced the authorization on July 21, 2026, saying the test is intended for use with whole blood from living patients and oral fluid from deceased people suspected of having had Ebola disease at death.

According to the company’s release, the rapid antigen test can detect the four Ebola viruses known to cause human disease: Bundibugyo, Zaire, Sudan and Taï Forest. OraSure said the newer version has greater sensitivity, updated chemistry and a more automated manufacturing process than its earlier test, which received FDA De Novo marketing authorization in 2019. The second-generation test was developed with support from the Biomedical Advanced Research and Development Authority under a 2022 contract.

OraSure said the test is designed as a single-use qualitative immunoassay and produces results on the device in about 30 minutes without laboratory equipment, batteries, smartphones or instruments. The company said it does not distinguish between Ebola virus types, but can aid diagnosis in symptomatic people with relevant exposure risks and help guide safe burial practices for recently deceased suspected cases.

The release linked the authorization to an Ebola outbreak in Central Africa involving Bundibugyo virus and said OraSure is increasing production to address possible demand. As background, rapid diagnostics can be important in Ebola responses because early identification and infection-control decisions are central to limiting spread, especially in settings with limited laboratory capacity.