OraSure's Rapid Ebola Test Deployed as Bundibugyo Virus Surges

BETHLEHEM, PA – July 21, 2026 – As a deadly Ebola outbreak fueled by the untreatable Bundibugyo virus tightens its grip on Central Africa, U.S. health officials have authorized a new diagnostic tool that could fundamentally alter the trajectory of the crisis. OraSure Technologies announced today it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its OraQuick™ Ebola 2.0 Rapid Antigen Test, a second-generation device capable of delivering results in 30 minutes from a single drop of blood.

The authorization arrives at a critical juncture. The World Health Organization has declared the epidemic a global public health emergency, with hundreds of deaths reported across the Democratic Republic of the Congo and neighboring Uganda. The new test, which can also be used on oral fluid from the deceased, is designed to detect all four Ebola viruses known to infect humans, a crucial feature in a complex outbreak. Developed in partnership with the U.S. government's Biomedical Advanced Research and Development Authority (BARDA), the test is now being fast-tracked into production.

“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.”

A Critical Tool for a Challenging Outbreak

The current Ebola epidemic presents a formidable public health challenge, distinguished by the resurgence of the Bundibugyo virus. Unlike the Zaire strain, for which effective vaccines and treatments were developed following the West African epidemic of 2014-2016, Bundibugyo has no approved countermeasures. This therapeutic void makes rapid diagnosis and containment the primary weapons in the global health arsenal. Without the ability to quickly identify infected individuals, the virus can spread silently through communities, overwhelming fragile health systems.

OraSure’s test directly addresses this diagnostic gap. Its ability to detect not only Bundibugyo but also the Zaire, Sudan, and Taï Forest strains provides a comprehensive screening tool for frontline workers facing an unpredictable viral landscape. Fast, accurate identification allows for the immediate isolation of infected patients, preventing further transmission. It also enables healthcare providers to allocate scarce resources effectively and begin supportive care sooner, improving patient outcomes even without a targeted therapy.

Furthermore, the test's authorization for use with cadaveric oral fluid is a vital component of outbreak control. Traditional burial practices in the region often involve close contact with the deceased, who can remain highly infectious. The ability to safely and quickly confirm Ebola as the cause of death allows health teams to work with families to implement safe burial protocols, a practice proven to be one of the most effective methods for breaking chains of transmission. By providing a definitive answer within 30 minutes, the test helps navigate these sensitive cultural moments with scientific certainty, protecting both bereaved families and the wider community.

The Science of Speed: A Leap in Diagnostic Technology

The OraQuick™ Ebola 2.0 test is not merely an incremental update; it represents a significant technological advancement built on a platform already proven in the field. The original version, which received full De Novo marketing authorization from the FDA in 2019, was the first rapid antigen test ever to achieve this status for Ebola. The new generation builds on that legacy with enhanced features designed for the rigors of an active pandemic.

According to the company, the test incorporates new chemistry that delivers increased sensitivity. In the context of a disease like Ebola, higher sensitivity is paramount. It reduces the likelihood of false-negative results, ensuring that individuals in the early stages of infection, when viral loads might be lower, are still correctly identified. Catching cases early is essential for both patient prognosis and public health containment.

This scientific refinement is backed by a strategic investment in manufacturing. The shift to a more automated production process is a key enabler for scaling up supply to meet emergency demand. This automation not only increases volume but also enhances consistency and quality control, ensuring that every test deployed to the field performs reliably. This public-private partnership model, driven by a 2022 contract with BARDA, exemplifies a modern approach to pandemic preparedness. BARDA's role is to de-risk and accelerate the development of critical medical countermeasures that the private market might be slow to pursue independently. By providing federal funds and technical support, BARDA ensures that tools like the OraQuick test are ready before a crisis reaches its peak.

Empowering the Frontline: Diagnostics Beyond the Lab

Perhaps the most transformative aspect of the OraQuick™ Ebola 2.0 test is its profound simplicity. It is a fully self-contained, instrument-free device. It requires no electricity, no batteries, no smartphone, and no specialized laboratory analysis. This design liberates Ebola testing from the confines of established hospitals and labs, putting diagnostic power directly into the hands of those who need it most: the community health workers, nurses, and burial teams operating in remote villages and temporary treatment centers.

The current gold standard for Ebola diagnosis, the Reverse Transcription Polymerase Chain Reaction (RT-PCR) test, is highly accurate but logistically cumbersome. It requires samples to be transported, often over difficult terrain, to a centralized laboratory with sophisticated equipment and highly trained technicians. Results can take hours or even days to return—a dangerous delay when every minute counts.

"Having a reliable test that you can carry in a backpack and use in a village without power is a complete game-changer for outbreak response," noted a public health official with experience in prior Ebola epidemics. "It collapses the timeline from suspicion to action. You can test, isolate, and begin contact tracing in a single visit, rather than telling a worried family you'll be back in two days with a result. That efficiency saves lives, period."

This decentralization empowers local healthcare systems, reducing dependence on international teams and complex supply chains. By making diagnosis accessible at the point of care, the test enables a more agile and responsive public health strategy, allowing teams to quickly map the spread of the virus and focus resources where they will have the greatest impact.

Navigating the Regulatory Path and Market Landscape

The FDA's Emergency Use Authorization is a powerful regulatory mechanism designed for precisely this type of scenario. It allows for the rapid deployment of a promising medical product during a declared public health emergency when no adequate, approved alternatives are available. While an EUA is not the same as full marketing approval, it is a rigorous process where the agency determines that the product's known and potential benefits outweigh its known and potential risks.

For OraSure, this EUA represents both a validation of its technology and a significant responsibility. The company's history with the first-generation test, which successfully transitioned from emergency use to full De Novo authorization, provides a clear roadmap for the future of the 2.0 version. This track record demonstrates a commitment to meeting the highest regulatory standards, which builds confidence among global health partners and procurement agencies.

As the company ramps up production, it enters a diagnostic landscape where its product's unique features give it a distinct advantage. While lab-based PCR tests will remain crucial for confirmation and research, the need for a field-deployable, rapid, and instrument-free test is undisputed. The OraQuick™ Ebola 2.0 test is positioned to fill that critical niche, providing the speed and accessibility required to combat the outbreak on the front lines. The company's immediate focus is on scaling manufacturing to ensure this vital tool can reach the communities in Central Africa that are depending on it.