Cepheid, a Danaher company, today announced it has donated an initial shipment of Xpert® Hemorrhagic Fever panel tests to support the diagnostic response to the Ebola Bundibugyo (BDBV) outbreak in the Democratic Republic of the Congo (DRC) and Uganda. The World Health Organization (WHO) declared the outbreak a Public Health Emergency of International Concern on May 17, 2026.¹

The initial shipment of Xpert® Hemorrhagic Fever tests has arrived in the DRC. Cepheid is working toward additional production in close coordination with the U.S. government, WHO, the Africa Centres for Disease Control and Prevention, in-country ministries of health, and other partners to accelerate deployment as quickly as possible, in alignment with applicable regulatory pathways and public health coordination mechanisms.

“Cepheid is working urgently with global health partners to deploy the Xpert Hemorrhagic Fever panel test in affected regions, particularly in regions at high risk of cross-border transmission,” said Dr. Connie Savor, Chief Medical Officer, Cepheid. “Cepheid's decentralized access on the existing GeneXpert installed base across Africa enables the global public health community to scale the response and supports fast isolation, treatment, and outbreak control.”

“The response is only possible through coordinated public-private partnerships,” said Larry Kelmar, Vice President, Government Programs and Pharmaceutical Collaborations, Cepheid. “Cepheid’s decades of experience addressing disease outbreaks and established partnerships enable us to efficiently respond and help get testing capabilities where they are most needed.”

The Xpert^® Hemorrhagic Fever panel test is FDA 510(k) cleared for use by the United States Department of Defense (DoD)² and part of DoD’s Next Generation Diagnostics System 2 Program. The assay detects and identifies nucleic acids of the following organisms: Ebola virus, including the Bundibugyo strain driving this outbreak, as well as Crimean Congo hemorrhagic fever (CCHF) virus, Marburg virus, and Lassa virus. The time to result is about one hour.

The Xpert^® Hemorrhagic Fever panel test runs on Cepheid’s GeneXpert^® systems. There is an extensive installed base of GeneXpert systems already deployed across DRC, Uganda, South Sudan, and Rwanda, offering vital infrastructure to support decentralized testing in outbreak-stricken regions.

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 Authorization³ 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-19,⁴ 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.⁵ In November 2024, it became the only point-of-care molecular test to receive WHO Emergency Use Listing for Mpox,⁶ 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. Not available in all countries.

References

1. World Health Organization. Epidemic of Ebola disease caused by Bundibyo virus… determined a public health emergency of international concern. 17 May 2026. Accessed June 2026.
2. U.S. FDA 510(k) Premarket Notification K253653. Accessed June 2026.
3. Cepheid News Release. Cepheid Receives Emergency Use Authorization from FDA for Xpert Ebola Diagnostic Test. March 14, 2015. Accessed June 2026.
4. 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.
5. U.S. FDA Bulletin 02/14/2023. Mpox Update: FDA authorizes Xpert Mpox Test. Accessed June 2026.
6. WHO News Release. WHO lists additional mpox diagnostic tests for emergency use. 30 October 2024. Accessed June 2026.

About Cepheid

Cepheid, a Danaher company, is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. Cepheid's GeneXpert^® systems and Xpert^® tests automate highly complex and time-consuming manual procedures, providing A Better Way for institutions of any size to perform world-class PCR testing. Cepheid's broad test portfolio spans respiratory infections, blood virology, women's and sexual health, TB and emerging infectious diseases, healthcare-associated infectious diseases, oncology, and human genetics. The company's solutions deliver actionable results where they are needed most—from central laboratories and hospitals to near-patient settings. For more information, visit www.cepheid.com.

About Danaher

Danaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health. Through our connected ecosystem of industry-leading businesses, we work side by side with customers to solve their most complex scientific and clinical challenges—helping move innovations from discovery to delivery faster for patients who depend on them. Powered by the Danaher Business System, our advanced science and technology and proven ability to innovate help enable faster, more accurate diagnoses and reduce the time, cost, and risk required to discover, develop, and deliver life-changing therapies. Through continuous improvement and operational excellence, our approximately 60,000 associates worldwide are focused on delivering lasting impact and improving quality of life around the world, while building a healthier, more sustainable tomorrow. Explore more at www.danaher.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260612089761/en/

For Cepheid Media Inquiries:
media.communications@cepheid.com

Logo

Tags

More Like This

Roche rapidly develops a PCR test for Ebola within six days as rare Bundibugyo virus drives urgent need for detection

Cepheid and Oxford Nanopore Technologies Partner to Advance Automated Sequencing-Based Solutions

PixCell Medical's HemoScreen CBC Analyzer Achieves IVDR Certification--A Game-Changer for Point-of-Care Diagnostics

/C O R R E C T I O N -- Roche/

KHB Becomes First Chinese Company to Obtain EU Class D IVDR Certification for Its Rapid Test HIV Colloidal Gold Diagnostic Kit

Beckman Coulter and Fujirebio Expand Partnership to Develop Patient-friendly, Blood-based Neurodegenerative Disease Diagnostics

Grifols Procleix ArboPlex Assay® Receives CE Mark, the First and Only 4-in-1 NAT for Arbovirus Screening

Seegene Develops mpox PCR Test Assays following the WHO Global Health Emergency Declaration