(RTTNews) - OraSure Technologies, Inc. (OSUR), a medical diagnostics company, announced the receipt of Emergency Use Authorisation from the U.S. Food and Drug Administration for OraQuick Ebola 2.0 Rapid Test Antigen for use with whole blood from live patients and cadaveric oral fluid from individuals suspected of Ebola disease.
OraQuick Ebola 2.0 Rapid Antigen Test is a single-use qualitative immunoassay that detects antigens from all four disease-causing Orthoebolavirus species to aid Ebola diagnosis in symptomatic patients and deceased individuals.
The current test detects all four Ebola viruses known to cause disease in humans—Bundibugyo, Zaire, Sudan, and Taï Forest. The test delivers results in 30 minutes and requires no instruments, batteries, smartphones, or laboratory analysis, the company said.
The original OraQuick Ebola Antigen Test received FDA De Novo marketing authorisation in 2019 for the detection of Ebola virus.
OraSure said it is the first and only fully authorised rapid antigen test for Ebola detection; moving forward, the second-generation version features improved sensitivity, updated chemistry, and an automated manufacturing process.
The second-gen test was developed in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) under a contract awarded in 2022.
OraSure also added that it is scaling up 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.
Carrie Eglinton Manner, President and CEO of OraSure, commented, "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."
OraSure shares closed Tuesday at $3.80, down 1.30%. In the overnight market, shares are trading up 1.05% at $3.84.
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