The World Health Organization (WHO) has approved the first mpox in vitro diagnostic (IVD) test for emergency use.
The announcement was made by Tedros Adhanom Ghebreyesus on X, as the global demand for mpox testing increased due to ongoing outbreaks in some countries, particularly in the Democratic Republic of the Congo (DR Congo).
The approval for emergency use of the Alinity m MPXV assay, manufactured by Abbott Molecular, will be “pivotal” in expanding diagnostic capacity in countries facing mpox outbreaks, WHO said.
“Early diagnosis of mpox enables timely treatment and care, and control of the virus,” it underlined.
Limited testing capacity and delays in confirming mpox cases persist in Africa, contributing to the continued spread of the virus. Over 30,000 suspected cases have been reported across the region in 2024.
The highest numbers are in the DR Congo, Burundi, and Nigeria, according to the agency, while 37% of suspected cases have been tested just in the DR Congo this year.
“This first mpox diagnostic test listed under the Emergency Use Listing (EUL) procedure represents a significant milestone in expanding testing availability in affected countries,” WHO assistant director-general for access to medicines and health products, Yukiko Nakatani, said.
“Increasing access to quality-assured medical products is central to our efforts in assisting countries to contain the spread of the virus and protect their people, especially in underserved regions,” Nakatani added.
The EUL process accelerates the availability of life-saving medical products, such as vaccines, tests, and treatments, in the context of a Public Health Emergency of International Concern.
So far, WHO has received three additional submissions for EUL evaluation, and discussions with other mpox IVD manufacturers are underway to ensure a wider range of quality-assured diagnostic options.