WHO approves first Mpox diagnostic test for emergency use

The World Health Organization (WHO) has approved the first emergency use diagnostic test for mpox, developed by Abbott Laboratories.

This move aims to enhance the capacity for early detection in regions currently experiencing outbreaks.

The test, named the Alinity m MPXV assay, employs real-time PCR technology to detect mpox virus DNA from human skin lesion swabs, facilitating accurate and timely diagnosis.

It is intended for use by trained laboratory professionals, according to the WHO’s announcement on October 4, 2024.

Yukiko Nakatani, WHO's assistant director-general for access to medicines and health products, emphasized that the approval of this diagnostic tool under the Emergency Use Listing (EUL) procedure is a significant step in addressing the ongoing outbreak.

The EUL procedure allows for a risk-based assessment of unlicensed vaccines, treatments, and tests to speed up their availability during public health emergencies.

This milestone approval is expected to play a critical role in regions struggling to contain the virus, particularly in lower-income countries.

In addition to this approval, the WHO is currently reviewing three more mpox diagnostic tests for potential emergency use authorization and is actively engaging with manufacturers to further broaden diagnostic capabilities.

These efforts are aimed at mitigating the spread of the virus and ensuring swift detection in both high-risk and low-income populations.

The approval of the Abbott mpox test comes after the WHO declared mpox a global public health emergency for the second consecutive year in August 2024, following outbreaks in the Democratic Republic of Congo (DRC) and neighboring countries such as Burundi, Uganda, and Rwanda.

Two primary strains of the virus, Clade I and Clade Ib, are currently circulating. Clade I is endemic to parts of West and Central Africa, while Clade Ib, a more transmissible variant, has raised concerns due to its rapid spread beyond Africa.

Recent cases of Clade Ib have been reported in countries such as Sweden, Thailand, and India, indicating the virus’s growing global footprint.

India reported its first case of the more virulent Clade Ib strain last month in Kerala, heightening concerns among public health officials regarding the strain’s fast transmission capabilities.

The infected individual, a 38-year-old man, had returned from Dubai shortly before the diagnosis.

Efforts to combat the mpox outbreak have intensified globally, particularly in Europe and India. The European Union (EU) has recently approved the use of Bavarian Nordic's mpox vaccine for adolescents, expanding vaccination efforts amid rising case numbers.

The vaccine, marketed under the name IMVANEX® in the EU, was initially approved for adults but was extended to adolescents aged 12 to 17 after a swift review by the European Medicines Agency (EMA).

The decision followed a clinical study that demonstrated comparable immune responses between adolescents and adults, with both groups showing a similar safety profile after receiving two doses of the vaccine.

This development underscores the EU’s commitment to protecting vulnerable populations, particularly children and adolescents who have been disproportionately affected by the ongoing outbreak.

The approval is also a crucial step in enhancing global immunization efforts, especially in African regions still grappling with the epidemic.

In India, health officials are closely monitoring the spread of the Clade Ib strain, with the government emphasizing the need for stringent testing and vaccination efforts to curb the virus's transmission.

The WHO’s approval of the Abbott diagnostic test is expected to bolster these efforts, enabling more precise detection and timely intervention.

As the WHO continues to evaluate additional diagnostic tools and collaborate with manufacturers, the international health community remains focused on expanding both testing and vaccination strategies to mitigate the impact of mpox worldwide.