FDA authorizes OraSure’s rapid test for Bundibugyo Ebola virus

The FDA on Tuesday granted Emergency Use Authorization to OraSure Technologies ↗ 0.00% for its OraQuick Ebola 2.0 Rapid Antigen Test, a second-generation diagnostic capable of detecting the Bundibugyo virus driving the current Ebola epidemic in Central Africa.stocktitan+2

A Faster Path to Diagnosis

The test can identify all four Ebola viruses known to cause disease in humans — Bundibugyo, Zaire, Sudan, and Taï Forest — and delivers results in 30 minutes without instruments, batteries, or laboratory analysis. It works on whole blood from living patients and on cadaveric oral fluid from recently deceased individuals, enabling both timely treatment decisions and safe burial practices that are critical to containing transmission.marketwatch+2

"We are proud to advance a second-generation Ebola test at a time when the world is confronting a serious and evolving outbreak in Central Africa," said Carrie Eglinton Manner, President and CEO of OraSure. "This outbreak is particularly challenging due to the Bundibugyo virus, which has no approved vaccine or targeted treatment, reinforcing the critical need for rapid, accurate diagnostics."stocktitan

Upgrades Over the Original

The original OraQuick Ebola Rapid Antigen Test received De Novo FDA marketing authorization in 2019, becoming the first and only rapid antigen test fully authorized for Ebola detection in the United States. The second-generation version features increased sensitivity, updated chemistry, and a more automated manufacturing process. It was developed in cooperation with the Biomedical Advanced Research and Development Authority under a federal contract granted in 2022.fiercebiotech+2

OraSure said it is ramping up production to meet potential demand.taiwannews

An Outbreak Without Approved Treatments

The authorization comes as the Ebola epidemic caused by the Bundibugyo virus continues to spread across the Democratic Republic of the Congo and into Uganda. As of July 19, the DRC had reported 2,423 confirmed cases including 967 deaths, according to the European Centre for Disease Prevention and Control. Unlike the better-known Zaire strain, the Bundibugyo virus has no approved vaccine or targeted therapeutic, leaving responders reliant on supportive care, contact tracing, and infection control measures. Médecins Sans Frontières has called rapid diagnosis a major obstacle in the response, citing insufficient quantities of virus-specific PCR diagnostic kits for Bundibugyo.ecdc.europa+2