As part of ongoing efforts to enhance quality-assured testing options, the World Health Organization (WHO) has listed two additional mpox in vitro diagnostics under its Emergency Use Listing (EUL) procedure. WHO’s EUL is based on the review of quality, safety and performance data in compliance with international standards while addressing the specific needs of low- and middle-income countries (LMICs).
Polymerase Chain Reaction (PCR) testing, which detects viral DNA, is considered the gold standard for diagnosing mpox infection.
WHO listed the Xpert Mpox, a real-time PCR test manufactured by Cepheid under its EUL procedure, on 25 October. This test is designed for use on compatible GeneXpert systems. The Xpert Mpox test is easy to operate and delivers results in under 40 minutes. Once the cartridge is placed in the system, the process is fully automated, with real-time PCR detecting viral DNA of monkeypox virus clade II. The GeneXpert system is a near-point-of-care testing option, which can support decentralized testing.
Another PCR-based option, the cobas MPXV assay, developed by Roche Molecular Systems, Inc., was listed on 14 October 2024. It is intended for use on the cobas 6800/8800 Systems. This tool is a real-time PCR test capable of detecting both mpox clades and delivering results in under 2 hours. It can process multiple samples simultaneously and is suitable for clinical laboratories that handle large volumes of tests.
“Ensuring global access to mpox diagnostic tests that meet WHO standards for quality, safety and performance is essential for efficient and effective testing in settings affected by mpox outbreaks,” said Dr Rogerio Gaspar, WHO Director for Regulation and Prequalification. “Rapid access to those listed products is critical not only for prompt diagnosis and timely treatment but also for effectively containing the spread of the virus."
WHO previously listed Alinity m MPXV assay, manufactured by Abbott Molecular Inc. under EUL on 3 October.
In 2024, 18 countries have reported over 40 000 suspected mpox cases with most remaining unconfirmed due to limited testing capacity, especially in LMICs. In the Democratic Republic of the Congo—the hardest-hit country—testing has significantly increased in 2024, following efforts to decentralize testing with support from WHO and partners. However, the proportion of tested cases remains low, accounting for 40-50% of the suspected cases.
WHO is working with manufacturers of the EUL-listed products and national regulatory authorities in affected countries to facilitate domestic registration or emergency listing. Fast-tracking approvals and applying reliance principles will enhance access to quality-assured mpox tests.
Overall, WHO has received over 60 expressions of interest for the EUL review of mpox diagnostic tests. Seven of these progressed to EUL applications, with 2 products currently under review and 2 more expected soon.
The status of active applications and listed mpox diagnostics under WHO EUL procedure can be seen on WHO webpages.
After WHO Director-General Dr Tedros Adhanom Ghebreyesus declared mpox a public health emergency of international concern (PHEIC) on 14 August 2024, WHO called on mpox in vitro diagnostic manufacturers to submit expressions of interest for Emergency Use Listing on 28 August 2024.
WHO EUL is a risk-benefit assessment designed to meet urgent needs during public health emergencies based on limited available data, accelerating the availability of life-saving medical products such as vaccines, tests, and treatments. It assists decision-making for procurement by UN, partner agencies and Member States at international, regional and national levels. Under EUL, the manufacturers must commit to continue generating any missing information in order to fulfil prequalification requirements. Once this information is available, a prequalification application should be submitted to complete the full process for achieving a recommendation for international procurement in both emergency and non-emergency settings.
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Polymerase Chain Reaction (PCR) testing, which detects viral DNA, is considered the gold standard for diagnosing mpox infection.
WHO listed the Xpert Mpox, a real-time PCR test manufactured by Cepheid under its EUL procedure, on 25 October. This test is designed for use on compatible GeneXpert systems. The Xpert Mpox test is easy to operate and delivers results in under 40 minutes. Once the cartridge is placed in the system, the process is fully automated, with real-time PCR detecting viral DNA of monkeypox virus clade II. The GeneXpert system is a near-point-of-care testing option, which can support decentralized testing.
Another PCR-based option, the cobas MPXV assay, developed by Roche Molecular Systems, Inc., was listed on 14 October 2024. It is intended for use on the cobas 6800/8800 Systems. This tool is a real-time PCR test capable of detecting both mpox clades and delivering results in under 2 hours. It can process multiple samples simultaneously and is suitable for clinical laboratories that handle large volumes of tests.
“Ensuring global access to mpox diagnostic tests that meet WHO standards for quality, safety and performance is essential for efficient and effective testing in settings affected by mpox outbreaks,” said Dr Rogerio Gaspar, WHO Director for Regulation and Prequalification. “Rapid access to those listed products is critical not only for prompt diagnosis and timely treatment but also for effectively containing the spread of the virus."
WHO previously listed Alinity m MPXV assay, manufactured by Abbott Molecular Inc. under EUL on 3 October.
In 2024, 18 countries have reported over 40 000 suspected mpox cases with most remaining unconfirmed due to limited testing capacity, especially in LMICs. In the Democratic Republic of the Congo—the hardest-hit country—testing has significantly increased in 2024, following efforts to decentralize testing with support from WHO and partners. However, the proportion of tested cases remains low, accounting for 40-50% of the suspected cases.
WHO is working with manufacturers of the EUL-listed products and national regulatory authorities in affected countries to facilitate domestic registration or emergency listing. Fast-tracking approvals and applying reliance principles will enhance access to quality-assured mpox tests.
Overall, WHO has received over 60 expressions of interest for the EUL review of mpox diagnostic tests. Seven of these progressed to EUL applications, with 2 products currently under review and 2 more expected soon.
The status of active applications and listed mpox diagnostics under WHO EUL procedure can be seen on WHO webpages.
Editor’s note
After WHO Director-General Dr Tedros Adhanom Ghebreyesus declared mpox a public health emergency of international concern (PHEIC) on 14 August 2024, WHO called on mpox in vitro diagnostic manufacturers to submit expressions of interest for Emergency Use Listing on 28 August 2024.
WHO EUL is a risk-benefit assessment designed to meet urgent needs during public health emergencies based on limited available data, accelerating the availability of life-saving medical products such as vaccines, tests, and treatments. It assists decision-making for procurement by UN, partner agencies and Member States at international, regional and national levels. Under EUL, the manufacturers must commit to continue generating any missing information in order to fulfil prequalification requirements. Once this information is available, a prequalification application should be submitted to complete the full process for achieving a recommendation for international procurement in both emergency and non-emergency settings.
Continue reading...
