OraSure Receives Emergency Use Authorization for Second Generation Ebola Test
Rhea-AI Summary
OraSure Technologies (NASDAQ: OSUR) received U.S. FDA Emergency Use Authorization on July 21, 2026 for its second-generation OraQuick™ Ebola 2.0 Rapid Antigen Test. The test is authorized for use with whole blood from live patients and cadaveric oral fluid from individuals suspected to have had Ebola disease at death.
The assay detects all four Ebola viruses known to cause human disease (Bundibugyo, Zaire, Sudan, Taï Forest), offers increased sensitivity with new chemistry and more automated manufacturing, and delivers qualitative results in 30 minutes without instruments or lab analysis. It was developed in cooperation with BARDA under Contract No. 75A50122C00079.
Positive
- FDA EUA granted for second-generation OraQuick™ Ebola 2.0 Rapid Antigen Test
- Broad strain coverage detecting four human Ebola viruses including Bundibugyo
- Improved test performance with increased sensitivity and new chemistry
- Manufacturing efficiency via a more automated production process
- BARDA partnership under U.S. federal Contract No. 75A50122C00079
- 30-minute, instrument-free results supporting point-of-care and field use
Negative
- None.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 11 | FDA clearance | Positive | +4.0% | FDA clearance expanded access to decentralized STI sample collection and testing. |
| May 06 | Quarterly earnings | Negative | +4.3% | Revenue declined year over year amid operating and net losses. |
| Apr 22 | Earnings scheduling | Neutral | -2.2% | The company scheduled first-quarter results and its earnings call. |
| Apr 16 | Board appointment | Positive | -1.6% | OraSure appointed an independent director and announced board declassification plans. |
| Mar 17 | Operational update | Positive | -2.7% | OraSure highlighted regulatory submissions, cost reductions, and capital-allocation initiatives. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
OraSure’s regulatory and earnings announcements were followed by positive reactions, while several corporate and operational updates were followed by declines.
Key Terms
emergency use authorization regulatory
cadaveric oral fluid medical
qualitative immunoassay medical
orthoebolavirus medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
The rapid test detects the Bundibugyo virus associated with the current outbreak and can support the diagnosis of both symptomatic individuals and deceased patients.
BETHLEHEM, Pa., July 21, 2026 (GLOBE NEWSWIRE) -- 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.
About OraSure Technologies
OraSure Technologies, Inc. (“OraSure” and “OTI”) transforms health through actionable insight and decentralizes diagnostics to connect people to healthcare wherever they are. OTI improves access, quality, and value of healthcare with innovation in effortless tests and sample management solutions. Together with its wholly-owned subsidiaries, DNA Genotek Inc., Sherlock Biosciences, Inc., and BioMedomics, Inc., OTI is a leader in the development, manufacture, and distribution of rapid diagnostic tests and sample collection and stabilization devices designed to discover and detect critical medical conditions. OTI’s portfolio of products is sold globally to clinical laboratories, hospitals, physicians’ offices, clinics, public health and community-based organizations, research institutions, government agencies, pharmaceutical companies, and direct to consumers. For more information, please visit http://www.orasure.com
Forward Looking Statements
This press release contains certain “forward-looking statements.” Forward-looking statements are based on current expectations of future events and are not guarantees of future performance or results. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from expectations and projections. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: uncertainty of commercial success; ability to manufacture or have manufactured products in accordance with applicable specifications, performance standards and quality requirements; uncertainty of regulatory approvals; ability to comply with applicable regulatory requirements; uncertainty relating to patent protection and potential patent infringement claims; impact of competitors, competing products and technology changes and patents obtained by competitors; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; impact of negative economic conditions; changes in behavior and spending patterns of purchasers; trends toward healthcare cost containment; product efficacy or safety concerns resulting in product recalls or regulatory action; and changes to applicable laws and regulations. These and other factors that could affect our results are discussed more fully in our SEC filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2025, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.
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