Original from: Orasure
OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in point-of-care and home diagnostic testing and sample collection technologies, announced today that 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 for use with whole blood in live patients, as well as cadaveric oral fluid from individuals suspected to have had Ebola disease at the time of death. The test can detect all four Ebola viruses currently known to cause disease in humans: Bundibugyo, Zaire, Sudan, and Taï Forest.
The OraQuick® Ebola Rapid Antigen Test originally received De Novo marketing authorization from the FDA in 2019, making it the first and only rapid antigen test to receive full authorization for the detection of Ebola virus. The second-generation test authorized by the FDA has increased sensitivity, new chemistry, and a more automated manufacturing process. It was developed in cooperation with the Biomedical Advanced Research and Development Authority (BARDA) under a contract granted in 2022.
“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 that can detect this virus and support timely containment efforts.”
The current Ebola epidemic, centered in the Democratic Republic of the Congo with cases extending into neighboring Uganda, has already resulted in hundreds of deaths and prompted the World Health Organization to declare a global public health emergency. The Company is ramping up production of the OraQuick™ Ebola 2.0 Rapid Antigen Test to meet potential demand and expand access to a proven, reliable test.
The OraQuick™ Ebola 2.0 Rapid Antigen Test is a single-use, qualitative immunoassay designed to detect antigens from viruses within the Orthoebolavirus genus as an aid in the diagnosis of Ebola disease, though it does not differentiate between viruses. The test is intended for individuals suspected of and with signs and symptoms of Ebola disease consistent with known risk factors for exposure, as well as for recently deceased individuals suspected of having Ebola disease at the time of death, allowing for proper treatment in living patients and safe burial practices for the deceased. Results are available directly on the test device in 30 minutes, and do not require instruments, batteries, smartphones, or laboratory analysis.
This project has been funded in whole or in part with Federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50122C00079.
Source: OraSure Receives Emergency Use Authorization for Second Generation Ebola Test
