Ebola Outbreak 2026: Closing Critical Diagnostic Gaps

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June 12, 2026

COMMUNITY AND GLOBAL HEALTH

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Ebola Outbreak 2026: Closing Critical Diagnostic Gaps

Cepheid is mobilizing to support testing in DRC and Uganda

 

The 2026 Ebola outbreak in the Democratic Republic of the Congo (DRC) and neighboring Uganda is a rapidly evolving public health emergency unfolding in one of the most complex environments for outbreak response.¹,²

 

Ongoing conflict, population displacement, and cross-border movement are increasing the risk of transmission, while limited access to healthcare and laboratory services continues to delay diagnosis and treatment.

 

Rapid and accessible diagnostics are essential to outbreak response and broader health security. Diagnostic tests enable healthcare workers to identify suspected cases earlier, initiate isolation measures more quickly, support effective contact tracing, and inform implementation of public health measures to contain the outbreak.3

 

Diagnostic gaps exposed by the Bundibugyo strain

 

Ebola is not a single virus but a family of related viruses, and most previous outbreaks in the DRC have been caused by the Zaire strain, for which vaccines, diagnostics, and therapeutics are available. The 2026 outbreak presents a different challenge, as the Bundibugyo strain currently has no approved vaccines or targeted treatments, and existing countermeasures cannot be directly deployed.²

 

Further, as of late May 2026, no diagnostic tests are available with the required infrastructure to support broad and immediate decentralized deployment in the affected countries.4

The current outbreak has highlighted how diagnostic gaps can accelerate the spread of disease. Early in the outbreak, available molecular tests, such as Xpert® Ebola,5 could not detect the circulating virus because they were designed to identify the more common Zaire strain and not the current Bundibugyo strain. Samples had to be transported to distant reference laboratories for confirmation, delaying diagnosis at a time when speed is critical.

 

In past outbreaks, up to 50% of patients infected with the Bundibugyo virus died.6 Stopping transmission of the virus is key to stopping the spread of the outbreak and averting deaths. Rapid, reliable diagnostic testing that is deployable in very decentralized settings is the key to identifying cases and appropriately responding to the outbreak. 

 

Cepheid’s response to the 2026 Ebola outbreak

 

In response to the current emergency, Cepheid teams are actively mobilizing to support diagnostic needs in affected regions, working in close coordination with global health partners. These efforts are aligned with broader health security and outbreak preparedness priorities, particularly in regions at high risk of cross-border transmission.

 

The Xpert® Hemorrhagic Fever panel,7 originally received FDA clearance to be used by the United States Department of Defense in health security and biothreat preparedness programs. Cepheid is now mobilizing this test to support the ongoing outbreak, in alignment with applicable regulatory pathways and public health coordination mechanisms. The test is designed to detect multiple high-consequence pathogens, including Ebola virus across several species such as Bundibugyo, as well as other viruses causing hemorrhagic fevers.

 

Cepheid is actively working to leverage GeneXpert® systems that are widely deployed across Africa to support detection of the Bundibugyo strain using the Xpert Hemorrhagic Fever test. These systems have been used in previous Ebola outbreaks to support molecular diagnosis.8 This installed base allows testing capacity to be expanded rapidly through existing systems, without the need to establish new laboratory networks.

 

Expanding detection capabilities through this infrastructure can enable faster access to testing in decentralized and hard-to-reach areas, reduce delays associated with sample transport, and support earlier case identification. By strengthening access to timely diagnostics, these efforts contribute directly to outbreak containment and reinforce regional preparedness for current and future threats.

 

Cepheid is working with public health stakeholders and authorities to support deployment efforts that align with outbreak response priorities and supports frontline teams.

 

A legacy of responding in times of need

 

Cepheid has a long history of supporting public health responses during infectious disease outbreaks, with a focus on expanding access to rapid molecular diagnostics in decentralized settings.

 

This experience has consistently shown that bringing accurate testing closer to patients can significantly improve response times,9 particularly in regions where access to centralized laboratory infrastructure is limited. Across previous outbreaks, scalable molecular diagnostics have supported early detection and effective implementation of public health interventions, contributing to preparedness and resilience of health systems.

 

Looking ahead: strengthening diagnostic readiness

 

The current Ebola outbreak highlights the importance of preparedness for a wide range of infectious threats, including less common strains that may not be covered by existing countermeasures.

 

While vaccines and therapeutics remain essential components of long-term response, the early phase of outbreak control depends heavily on diagnostics.

 

Cepheid continues to collaborate with partners and public health authorities to support response efforts, with a focus on expanding access to timely and reliable molecular testing. Strengthening diagnostic readiness is a key component of global health security and remains essential to improving outbreak response and helping contain the spread of infectious diseases.

Frequently Asked Questions

 

Q. How is Cepheid responding to the 2026 Ebola outbreak?

A. On June 12, Cepheid announced the company donated an initial delivery of Xpert® Hemorrhagic Fever panel tests10 and is working towards an additional build of tests in close coordination with the U.S. government, WHO, Africa Centres for Disease Control and Prevention, in-country ministries of health and others to advance deployment as quickly as possible in alignment with applicable regulatory pathways and public health coordination mechanisms.

Q. What virus strains does Cepheid’s Xpert® Hemorrhagic Fever panel detect?

A. Cepheid’s Xpert® Hemorrhagic Fever panel is a multiplex assay designed to detect multiple high-consequence viral hemorrhagic fever agents, including Ebola virus (including Zaire, Sudan, Taï Forest, and Bundibugyo, not differentiated) — as well as Marburg virus, Lassa virus, and Crimean-Congo hemorrhagic fever (CCHF) virus.7

Q. How accurate is the Xpert Hemorrhagic Fever panel in detecting the 2026 Bundibugyo strain?

A. Analytical performance for each viral hemorrhagic fever agent species the panel detects is documented in the FDA 510(k) Summary publicly available on the FDA website (K253653).7

Q. How quickly does the Xpert Hemorrhagic Fever panel produce a result?

A. Turnaround time from sample to result is approximately one hour. Test performance is available in the FDA 510(k) Summary publicly available on the FDA website (K253653).7

Q. What is Cepheid's history with Ebola and hemorrhagic fever diagnostics?

A. Cepheid has supported public health responses to Ebola for more than a decade. During the 2014-2016 West Africa outbreak, the Xpert® Ebola test received FDA Emergency Use Authorization11 and was deployed across affected regions, demonstrating that rapid molecular testing in decentralized settings could close the gap between symptom onset and laboratory confirmation.

Cepheid has more than 20 years of experience responding to infectious disease emergencies. In early 2020, Cepheid was first to receive FDA Emergency Use Authorization (EUA) for a point-of-care molecular PCR test for COVID-19,12 with authorization coming within weeks of the SARS-CoV-2 viral sequence becoming available. In February 2023, Xpert® Mpox received the first FDA EUA for a point-of-care molecular test for Mpox.13 In November 2024, it became the only point-of-care molecular test to receive WHO Emergency Use Listing for Mpox,14 extending access to resource-limited settings globally. With GeneXpert systems deployed across more than 180 countries, Cepheid’s established global infrastructure is built for precisely this kind of rapid, at-scale response.

IVD. In Vitro Diagnostic Medical Device. May not be available in all countries.

References

  1. World Health Organization. Epidemic of Ebola disease in the Democratic Republic of the Congo and Uganda determined a public health emergency of international concern, 17 May 2026.
  2. European Centre for Disease Prevention and Control. WHO declares Ebola outbreak in DRC and Uganda a PHEIC.17 May 2026.
  3. Hampton LM. et al. Ebola outbreak detection and response since 2013. Lancet Microbe. 2023 Sep;4(9):e661–e662.
  4. Africa Centers For Disease Control and Prevention. Molecular Diagnostic Tests (RT-PCR) for Ebola Virus Bundibugyo Strain. Recommendations as per 22 May 2026. Molecular Diagnostic Tests (RT-PCR) for Ebola Virus Bundibugyo Strain – Africa CDC
  5. Xpert Ebola Xpert Ebola Assay - IFU intended for the qualitative detection of RNA from the Ebola virus (species Zaire ebolavirus). Available under an Emergency Use Authorization (EUA) in the United States and WHO Emergency Use License (EUL).
  6. World Health Organization. Ebola disease caused by Bundibugyo virus, Democratic Republic of the Congo & Uganda. 16 May 2026.
  7. U.S. Food and Drug Administration. Xpert® Hemorrhagic Fever Test 510(k) Summary (K253653).
  8. Mukadi-Bamuleka D. et al. Head-to-head comparison of diagnostic accuracy of four Ebola virus disease rapid diagnostic tests versus GeneXpert® in eastern Democratic Republic of the Congo outbreaks: a prospective observational study. EBioMedicine. 2023 May:91:104568.
  9. Butler D. Speedy Ebola tests help contain Africa’s latest outbreak. Nature. 2018;558(7709):172. doi:10.1038/d41586-018-05389-2.
  10. Cepheid News Release. Cepheid Xpert® Hemorrhagic Fever Panel Tests Delivered to Africa to Address Diagnostic Gaps in Ebola Bundibugyo Outbreak. June 12, 2026.
  11. Cepheid News Release. Cepheid Receives Emergency Use Authorization from FDA for Xpert Ebola Diagnostic Test. March 14, 2015. Accessed June 2026.
  12. U.S. FDA News Release. Coronavirus (COVID-19) Update: FDA Issues First Emergency Use Authorization for Point of Care Diagnostic. March 21, 2020. Accessed June 2026.
  13. U.S. FDA Bulletin 02/14/2023. Mpox Update: FDA authorizes Xpert Mpox Test. Accessed June 2026.
  14. WHO News Release. WHO lists additional mpox diagnostic tests for emergency use. 30 October 2024. Accessed June 2026.
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