Cepheid 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 shipment has arrived in the DRC, with Cepheid working on additional production in coordination with the U.S. government, World Health Organization, Africa Centres for Disease Control and Prevention, in-country ministries of health and other partners.
Delays in confirming Ebola and other viral hemorrhagic fevers can slow isolation, treatment and public health action, especially in regions at risk of cross-border transmission.
The Xpert Hemorrhagic Fever panel detects and identifies nucleic acids from Ebola virus, including the Bundibugyo strain driving the current outbreak, as well as Crimean-Congo hemorrhagic fever virus, Marburg virus and Lassa virus. The test provides results in about one hour.
The assay runs on Cepheid’s GeneXpert systems, which are already deployed across the DRC, Uganda, South Sudan and Rwanda. This installed base is important because it allows testing capacity to be scaled through existing diagnostic infrastructure, instead of relying only on central laboratories.
The 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. Cepheid also has prior outbreak response experience, including deployment of Xpert Ebola during the 2014 to 2016 West Africa outbreak and point-of-care molecular testing for COVID-19 and mpox.