WHO urges rapid access to mpox diagnostic tests, invites manufacturers to emergency review
The World Health Organization (WHO) has asked manufacturers of mpox in vitro diagnostics (IVDs) to submit an expression of interest for Emergency Use Listing (EUL).
WHO has been in ongoing discussions with manufacturers about the need for effective diagnostics, particularly in low-income settings. The request for EUL expressions of interest by manufacturers is the latest development in these discussions.
With as many as 1000 suspected cases reported in the Democratic Republic of the Congo alone this week, the demand for diagnostic tests is on the rise. In this heavily affected country, WHO has worked with partners to scale up diagnostic capacity to respond to the upsurge of cases. Since May 2024, six additional labs have been equipped to diagnose mpox, enabling a decentralization of testing capacity from major cities to affected provinces. Two of these labs are in South Kivu, selected to respond to the outbreak of the new viral strain, called Ib. Thanks to these efforts, testing rates have dramatically improved in the country, with four times as many samples tested in 2024 so far as compared to 2023.
WHO has also updated its diagnostic testing guidance to detect the new virus strain and is working with countries to roll it out. Earlier, WHO issued target product profiles to guide manufacturers in the development of new diagnostic tests.
Manufacturers of IVDs are now asked to submit available quality, safety and performance data to WHO as soon as they can.
