SWITZERLAND –The World Health Organization (WHO) has granted Emergency Use Listing (EUL) for Cepheid’s Xpert Mpox test, a major advancement for rapid Mpox diagnosis.
This approval comes at a critical time when the world is facing a surge in Mpox cases, particularly in regions with limited healthcare resources.
The test runs on Cepheid’s widely accessible GeneXpert platform and delivers results in under 40 minutes, making it suitable for decentralized, point-of-care use.
“Xpert Mpox is the only point-of-care molecular test with WHO Emergency Use Listing (EUL), making it a valuable preparedness and response tool that can be deployed quickly where accurate and actionable information is needed,” stated Vitor Rocha, President of Cepheid.
Addressing the Mpox Outbreak Crisis
Mpox has re-emerged as a global health threat, with over 40,000 suspected cases reported worldwide in 2024.
The hardest-hit regions are in Africa, particularly the Democratic Republic of the Congo (DRC), where testing limitations have left many suspected cases unconfirmed.
WHO data shows that only 40-50% of suspected Mpox cases in the DRC have been tested, despite expanded efforts to boost diagnostic capacity.
The spread of a new strain, clade Ib, has intensified the crisis, leading to confirmed cases not only in Africa but also in Europe, including countries like Sweden, Germany, and the UK.
The WHO’s declaration of Mpox as a public health emergency in August 2024 underscores the urgency of bolstering diagnostic capabilities to curb the virus’s transmission.
Importance of rapid, reliable diagnostics
Cepheid’s Xpert Mpox test is pivotal for distinguishing Mpox from other infections with similar presentations, such as chickenpox, measles, and syphilis.
The real-time PCR test can detect Mpox clade II, aiding healthcare providers in delivering timely diagnoses, initiating treatment, and preventing further spread.
“Ensuring global access to Mpox diagnostic tests that meet WHO standards for quality, safety, and performance is essential for efficient and effective testing in settings affected by Mpox outbreaks,” emphasized Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification.
He added that “rapid access to those listed products is critical not only for prompt diagnosis and timely treatment but also for effectively containing the spread of the virus.”
The WHO’s EUL process and additional approvals
The WHO’s Emergency Use Listing is a rigorous process designed to assess diagnostic tools’ safety, quality, and performance, especially in support of low- and middle-income countries (LMICs).
Cepheid’s Xpert Mpox test received its EUL on October 25, 2024, following the earlier approval of Roche’s cobas MPXV assay on October 14.
Roche’s cobas test provides results in under two hours and is suited for high-capacity clinical laboratories. Additionally, Abbott Molecular Inc.’s Alinity m MPXV assay was approved on October 3.
The WHO continues to collaborate with test manufacturers and national regulatory bodies to accelerate the approval and distribution of EUL-listed diagnostics in affected areas.
This includes fast-tracking regulatory processes and implementing reliance principles to ensure access to these vital tests.
