WHO Adds Two New Mpox PCR Tests to Emergency Use Listing to Enhance Global Testing Capacity

Cepheid and Roche Diagnostics Tests Provide Rapid and Decentralized Detection Options as Mpox Cases Continue to Rise Worldwide.

In a critical step to improve global diagnostics amid ongoing mpox outbreaks, the World Health Organization (WHO) has listed two new in vitro diagnostic tests for mpox under its Emergency Use Listing (EUL). WHO’s EUL procedure, which evaluates diagnostics for quality, safety, and performance, prioritizes tools that address the unique needs of low- and middle-income countries (LMICs) where access to reliable testing often lags.

Polymerase Chain Reaction (PCR) testing, known for its sensitivity and ability to detect viral DNA, is the current gold standard for diagnosing mpox infections. WHO’s recent listings include:

Xpert Mpox, a real-time PCR test from Cepheid, which can deliver results in under 40 minutes. Compatible with the widely used GeneXpert system, this test enables near-point-of-care diagnostics, supporting decentralized testing with minimal operator requirements. Listed on October 25, this test aims to enhance access to quality-assured diagnostics in remote or underserved regions.

cobas MPXV assay from Roche Molecular Systems, Inc., listed on October 14, which runs on the cobas 6800/8800 systems, ideal for high-volume clinical labs. With a result turnaround time of less than two hours, this test can detect both mpox clades, accommodating high-throughput settings to meet escalating testing demands.

The WHO EUL process also reviewed the Alinity m MPXV assay, produced by Abbott Molecular Inc., on October 3, making it the first mpox diagnostic to receive EUL listing this month.

“These new diagnostic tools are pivotal for ensuring efficient and effective mpox testing where it’s needed most,” said Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification. “Timely access to quality-assured tests is not only essential for rapid diagnosis and treatment but also for preventing further transmission.”

Mpox has emerged as a significant health concern, with more than 40,000 suspected cases reported across 18 countries in 2024 alone, though limited testing capacity in many LMICs has left numerous cases unconfirmed. The Democratic Republic of the Congo (DRC), currently the hardest-hit country, has seen substantial improvements in its testing capabilities this year due to decentralized testing support from WHO and partner organizations. Yet, despite these gains, tested cases represent only 40-50% of all suspected cases, underscoring the continued need for expanded access to diagnostic tools.

WHO is actively collaborating with manufacturers of EUL-listed products and national regulatory bodies to accelerate approvals for local distribution and emergency use. Fast-tracking these approvals through reliance on existing EUL reviews is expected to expedite the availability of quality-assured mpox tests in LMICs.

With rising demand, WHO reports receiving over 60 expressions of interest from companies seeking EUL assessment for mpox diagnostics, with seven advancing to the formal application stage. Currently, two products remain under review, with additional applications anticipated in the coming weeks.

This expanded diagnostic capacity aligns with WHO’s overarching strategy to manage mpox outbreaks through early diagnosis, timely treatment, and containment. WHO continues to encourage collaboration among countries, health organizations, and manufacturers to meet evolving health challenges and support LMICs in establishing resilient health systems.