WASHINGTON (dpa-AFX) - The World Health Organization has asked manufacturers of mpox diagnostics to submit expression of interest for emergency review to make it available faster.
WHO has been continuing discussions with manufacturers about the need for effective diagnostics, particularly in low-income countries, in the wake of the outbreak of the deadly viral disease in the Democratic Republic of the Congo and neighboring African countries.
Through the Emergency Use Listing (EUL) procedure, WHO can approve medical products such as vaccines, tests and treatments for use, evaluating the acceptability of using specific products for time-limited procurement in emergency situations. The process aims to assist countries, which have not approved the medical products through national approval processes, to procure the critically needed products such as tests through UN agencies and other partners.
Testing is key for people to get treatment and care as early as possible and prevent further spread. Since 2022, WHO has delivered around 150000 diagnostic test kits for mpox globally, a quarter of which have gone to countries in the African Region. WHO said it will deliver another 30000 tests to African countries in the coming weeks.
The World Health Organization earlier this month declared the mpox outbreak a public health emergency of international concern.
DR Congo is the worst-affected, with more than 15600 cases and 537 deaths reported so far this year.
With as many as 1000 suspected cases reported in the country 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, according to the UN health agency.
Manufacturers of IVDs are now asked to submit available quality, safety and performance data to WHO as soon as they can. IVDs are tests done in laboratories to detect a pathogen.
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