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In a bid to improve the availability of quality-assured testing solutions, the World Health Organization (WHO) has recently added two new mpox in vitro diagnostic tests to its Emergency Use Listing (EUL). The EUL process by WHO evaluates the quality, safety, and performance of these tests according to international standards while catering specifically to the needs of low- and middle-income countries (LMICs).
The Polymerase Chain Reaction (PCR) test, which identifies viral DNA, is recognized as the benchmark for diagnosing mpox infections.
On October 25th, WHO included the Xpert Mpox test—a real-time PCR diagnostic tool developed by Cepheid—in its EUL. This test is compatible with GeneXpert systems and is designed for ease of use. It provides results in less than 40 minutes. Once a cartridge is inserted into the system, it operates automatically; real-time PCR technology detects viral DNA from monkeypox virus clade II. The GeneXpert system serves as an efficient near-point-of-care testing solution that supports decentralized testing efforts.
Another PCR-based alternative listed under EUL is the cobas MPXV assay, created by Roche Molecular Systems Inc., which received approval on October 14th, 2024. This assay functions on cobas 6800/8800 Systems and can detect both mpox clades while delivering results in under two hours. It has the capability to process multiple samples at once and is ideal for clinical laboratories managing high volumes of tests.
“It’s crucial that we ensure global access to mpox diagnostic tools that adhere to WHO’s standards regarding quality, safety, and performance,” stated Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification. “Quick access to these approved products not only facilitates timely diagnosis but also plays a vital role in controlling virus transmission.”
Previously on October 3rd, WHO had also included the Alinity m MPXV assay from Abbott Molecular Inc. in its EUL listing.
This year alone has seen over 40 thousand suspected cases of mpox reported across 18 countries; however most remain unverified due to inadequate testing capabilities—particularly within LMICs. In regions like the Democratic Republic of Congo—the country most severely impacted—testing efforts have ramped up significantly this year thanks to initiatives aimed at decentralizing testing with support from WHO and other partners. Nevertheless, only about 40%–50% of suspected cases have been tested so far.
WHO continues collaborating with manufacturers whose products are listed under EUL along with national regulatory bodies within affected nations to expedite domestic registration or emergency listings for these diagnostics. By fast-tracking approvals through reliance principles, access will be improved for quality-assured mpox tests.
A total of over sixty expressions of interest have been submitted regarding EUL reviews for mpox diagnostics by various manufacturers; seven applications have progressed further into formal review processes—with two currently being evaluated and another pair expected soon.
The latest updates concerning active applications as well as listed diagnostics related to mpox can be found on WHO’s official website.
Note from Editors
Following Dr. Tedros Adhanom Ghebreyesus’ declaration on August 14th that classified mpox as a public health emergency of international concern (PHEIC), WHO urged manufacturers specializing in mpox diagnostic tools on August 28th to submit expressions indicating their interest in Emergency Use Listing.
The purpose behind WHOs’ Emergency Use Listing framework involves conducting risk-benefit assessments aimed at addressing urgent requirements during public health crises based upon limited data availability—thereby accelerating access towards essential medical products such as vaccines or treatments needed urgently during emergencies while assisting procurement decisions made by UN agencies alongside Member States globally at various levels including regional & national ones.
Under this framework however—it remains mandatory that all participating manufacturers continue gathering any outstanding information necessary fulfilling prequalification criteria before submitting full applications thereafter completing requisite processes leading towards recommendations facilitating international procurements whether during emergencies or otherwise!
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