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WHO Approves First Emergency Use Mpox Diagnostic Test

NextEdge Admin

04 Oct 2024

1 min 39 sec

The World Health Organization (WHO) has granted emergency use approval for Abbott Laboratories' PCR test, the Alinity m MPXV assay, designed to detect mpox virus DNA from human skin lesion swabs. This approval aims to enhance access to urgent medical testing, especially during public health emergencies. The test is intended for use by trained clinical lab personnel.

WHO is also assessing three additional mpox diagnostic tests for its Emergency Use Listing (EUL) and engaging with other manufacturers to expand the availability of testing tools. Roche and Labcorp are among the companies actively working to increase laboratory testing capacity for mpox.

The EUL procedure is a risk-based approach that accelerates the availability of vaccines, treatments, and diagnostics during public health crises. In August, WHO called on manufacturers to submit products for emergency review, highlighting the need for effective diagnostic solutions, particularly for low-income populations. This initiative aims to ensure broader and faster access to accurate mpox diagnostics, which is essential for controlling outbreaks and protecting vulnerable groups.