WHO clears in vitro diagnostic mpox testing for emergency use

On October 3, 2024, the WHO approved the first mpox in vitro diagnostic through its Emergency Use Listing procedure. According to the organization's press release, this approval marks a move toward global access to mpox testing, a positive step forward in public health efforts to mitigate disease spread.

The Alinity m MPXV assay is manufactured by Abbott Molecular Inc. and was authorized for emergency use by the FDA in October 2022, months after the HHS declared the mpox public health emergency.

The test is a real-time polymerase chain reaction (PCR) test that can detect the clade I and clade II mpox virus. Viral samples are collected from human lesion swabs, and the PCR is run by trained clinical laboratory personnel.

This procedure offers an alternative to nucleic acid amplification testing (NAAT) and conventional PCR.

"This first mpox diagnostic test listed under the Emergency Use Listing procedure represents a significant milestone in expanding testing availability in affected countries," said Yukiko Nakatani, M.D., Ph.D., WHO assistant director-general for access to medicines and health products, in the press release. "Increasing access to quality-assured medical products is central to our efforts in assisting countries to contain the spread of the virus and protect their people, especially in underserved regions."

The emergency approval of a real-time PCR diagnostic test offers a rapid diagnostic tool that can facilitate early diagnosis, timely treatment and containment of viral spread.

Diagnostic and prevention tools are increasingly critical as the virus continues to spread in Africa. According to the WHO press release, over 30,000 suspected cases of mpox have been reported in 2024.

In August 2024, the United States CDC published an official update on the mpox outbreaks and strains through the Health Alert Network. The CDC notes that clade I mpox cases have dramatically increased in the Democratic Republic of Congo (DRC), from 3,767 cases annually between 2016 and 2021 to over 22,000 suspected cases in 2023.

Although clade I mpox is endemic to the DRC, the ongoing outbreaks are impacting many neighboring communities, including the Central African Republic, the Republic of Congo, Rwanda and Uganda. There are also suspected mpox cases in Burundi; however, the clade has not been confirmed.

In its report, the CDC maintained that the risks of disease domestically are relatively low due to the limited number of travelers and direct commercial flights from the DRC and surrounding countries to the U.S. However, the organization acknowledges ongoing concerns about the disease's spread and the risk of transmission.

Moreover, shortly after the report from the CDC, the WHO declared the mpox outbreaks a global health emergency. Tedros Adhanom Ghebreyesus, Ph.D., WHO director-general, convened an emergency meeting of the International Health Regulations Emergency Committee, comprised of independent experts, to advise on the ongoing mpox threat. The meeting solidified concerns and informed the declaration of a global health emergency.

Even with diagnostic tools, such as the Alinity m MPXV assay, available, it is critical to monitor the spread of the disease and focus on preventing infection through public health practices, including vaccination.

Veronica Salib has covered news related to the pharmaceutical and life sciences industry since 2022.