Sunnyvale, Calif. — Cepheid, a Danaher company, said it has donated an initial shipment of Xpert® Hemorrhagic Fever panel tests to support the diagnostic response to the Ebola Bundibugyo outbreak in the Democratic Republic of the Congo and Uganda.
The World Health Organization declared the outbreak a Public Health Emergency of International Concern on May 17, 2026.
The initial shipment of Xpert® Hemorrhagic Fever tests has arrived in the DRC. Cepheid said it is working on additional production in coordination with the U.S. government, WHO, the Africa Centres for Disease Control and Prevention, in-country ministries of health and other partners to speed deployment in line 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 and is part of the DoD’s Next Generation Diagnostics System 2 Program. The assay detects and identifies nucleic acids of Ebola virus, including the Bundibugyo strain driving the outbreak, as well as Crimean-Congo hemorrhagic fever virus, Marburg virus and Lassa virus. Results are available in about one hour.
The test runs on Cepheid’s GeneXpert® systems, which are already widely deployed across the DRC, Uganda, South Sudan and Rwanda. The company said the existing installed base provides infrastructure to support decentralized testing in regions affected by the outbreak.
Cepheid has supported Ebola public health responses for more than a decade. During the 2014-2016 West Africa outbreak, the Xpert® Ebola test received FDA Emergency Use Authorization and was deployed across affected regions, helping demonstrate the role of rapid molecular testing in narrowing the gap between symptom onset and laboratory confirmation.
The company said it has more than 20 years of experience responding to infectious disease emergencies. In early 2020, Cepheid received FDA Emergency Use Authorization for a point-of-care molecular PCR test for COVID-19 within weeks of the SARS-CoV-2 viral sequence becoming available. In February 2023, Xpert Mpox received the first FDA Emergency Use Authorization for a point-of-care molecular test for Mpox. In November 2024, it became the only point-of-care molecular test to receive WHO Emergency Use Listing for Mpox, expanding access to resource-limited settings globally.
Cepheid said its GeneXpert systems are deployed across more than 180 countries, providing global infrastructure for rapid outbreak response.
