FDA Grants Emergency Use Authorization to OraSure’s Second‑Generation OraQuick Ebola 2.0 Rapid Antigen Test

OraSure Technologies, Inc. (OSUR) announced that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for its OraQuick Ebola 2.0 Rapid Test Antigen, which can be applied to whole blood from living patients and cadaveric oral fluid from individuals suspected of Ebola disease.

The OraQuick Ebola 2.0 Rapid Antigen Test is a single‑use qualitative immunoassay that identifies antigenic signatures from all four Ebola virus species that affect humans—Bundibugyo, Zaire, Sudan, and Taï Forest—thereby supporting diagnosis in symptomatic patients and deceased individuals.

The new assay delivers results within 30 minutes and does not require instruments, batteries, smartphones, or laboratory analysis, according to the company.

OraSure highlights that its earlier OraQuick Ebola Antigen Test received FDA De Novo marketing authorization in 2019 for Ebola virus detection, and that the current second‑generation version offers improved sensitivity, updated chemistry, and an automated manufacturing process.

The development of the OraQuick Ephesians 2.0 test south for E in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) under a contract awarded in 2022.

OraSure is expanding production of the OraQuick Ebola 2.0 Rapid Antigen Test to meet expected demand amid the ongoing Ebola outbreak in the Democratic Republic of the Congo and Uganda.

“This outbreak is particularly challenging due to the Bundibugyo virus, which has no approved vaccine or targeted treatment,” said Carrie Eglinton Manner, President and CEO of OraSure. “Rapid, accurate diagnostics are critical for detecting this virus and supporting timely containment efforts.”

OraSure shares closedPIN at $3.80, down 1.30%. In the overnight market, shares are trading up 1.05% at $3.84.

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