WHO Urges Manufacturers to Submit Mpox Diagnostic Tests

The World Health Organization (WHO) has called on manufacturers of mpox in vitro diagnostics (IVDs) to submit expressions of interest for Emergency Use Listing (EUL). This request is the latest development in ongoing discussions aimed at ensuring effective diagnostic tools, particularly in low-income settings.

Accurate testing is vital for early treatment and care, helping to prevent further spread of the virus. Since 2022, WHO has distributed approximately 150,000 diagnostic tests worldwide, with over 25% allocated to countries in the African Region. In the coming weeks, an additional 30,000 tests will be sent to African nations, highlighting the growing demand for these diagnostics.

In the Democratic Republic of the Congo (DRC), where nearly 1,000 suspected cases have been reported in just one week, WHO has collaborated with partners to enhance diagnostic capacity. Since May 2024, six new labs have been equipped to diagnose mpox, decentralizing testing from major cities to affected provinces. Two of these labs are in South Kivu, strategically located to address the outbreak of a new viral strain, Ib. This expansion has led to a significant increase in testing rates, with four times as many samples tested in 2024 compared to 2023.

WHO has also updated its diagnostic guidance to detect the new strain and is working with countries to implement these updates. The organization previously issued target product profiles to assist manufacturers in developing new tests.

On August 14, 2024, WHO Director-General Dr. Tedros Adhanom Ghebreyesus declared the mpox surge in the DRC and other African countries a Public Health Emergency of International Concern (PHEIC) under the International Health Regulations (2005).

Manufacturers of IVDs are now urged to submit quality, safety, and performance data to WHO as soon as possible. The gold standard for mpox diagnosis is the detection of viral DNA through PCR (Polymerase Chain Reaction) testing, which identifies the virus in samples taken from skin lesions. Testing of blood is not recommended for routine diagnosis.

The EUL procedure allows WHO to approve medical products for emergency use, facilitating time-limited procurement by countries lacking national approval processes. This initiative is crucial for expanding access to diagnostic services, strengthening laboratory capacity, improving case investigation, and enhancing surveillance efforts.