WHO approves first mpox diagnostic test for emergency use, expanding global testing capacity

The World Health Organization (WHO) has taken a significant step in the fight against mpox by approving the first in vitro diagnostic (IVD) test for emergency use. The Alinity m MPXV assay, developed by Abbott Molecular Inc., will enhance global access to mpox testing, particularly in countries grappling with outbreaks like the Democratic Republic of the Congo, Burundi, and Nigeria.

This new PCR test allows for quick, accurate diagnosis of the virus from skin lesion samples, enabling timely treatment and containment of mpox. The Emergency Use Listing (EUL) process fast-tracks life-saving medical products during public health emergencies, ensuring countries have the necessary tools to address outbreaks.

Dr. Yukiko Nakatani, WHO’s Assistant Director-General for Access to Medicines and Health Products, emphasized that the approval marks a major milestone in increasing access to quality diagnostic tools, especially in underserved regions.

With more submissions for EUL under review, the global effort to improve mpox testing capacity continues to gain momentum, promising better health outcomes and prevention efforts worldwide.