WHO Approves First Mpox Diagnostic Test Under Emergency Use Listing

The World Health Organization (WHO) has listed the first mpox in vitro diagnostic (IVD) under its Emergency Use Listing (EUL) procedure, marking a key step towards improving global access to mpox testing. The Alinity m MPXV assay, developed by Abbott Molecular Inc., has been approved for emergency use, which will significantly enhance diagnostic capacity in countries grappling with mpox outbreaks. With the surge in demand for fast and accurate testing, this approval is crucial for timely diagnosis, treatment, and control of the virus.

Africa, where testing capacity remains limited, continues to face delays in confirming mpox cases, contributing to the virus's spread. In 2024, over 30,000 suspected cases have been reported in the region, with the highest numbers seen in the Democratic Republic of the Congo, Burundi, and Nigeria. In the DRC alone, only 37% of suspected cases have been tested this year.

According to WHO’s Interim Guidance on Diagnostic Testing for mpox, nucleic acid amplification tests (NAAT), such as PCR, are used to confirm the presence of the virus. Skin lesion material is the recommended specimen type for diagnostic confirmation. The Alinity m MPXV assay is a real-time PCR test designed for use by trained laboratory personnel, detecting mpox virus DNA from pustular or vesicular rash samples, enabling quicker and more efficient confirmation of cases.

Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, emphasized the importance of this milestone in making mpox testing more accessible in affected regions. The EUL procedure plays a crucial role in expediting access to life-saving medical products, including diagnostic tests, vaccines, and treatments, in the event of a Public Health Emergency of International Concern (PHEIC).

In response to the ongoing mpox outbreaks, WHO invited manufacturers to submit expressions of interest for EUL approval of diagnostic tests in August 2024. So far, WHO has received three additional submissions, and discussions are ongoing with other manufacturers to ensure a wider range of quality-assured diagnostic options. The EUL listing for the Alinity m MPXV assay will remain valid as long as the PHEIC is in effect. This listing will allow countries without their own approval processes to procure tests through UN agencies and procurement partners. Further information on active EUL applications for mpox IVDs is available on WHO’s website.