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World Health Organization Adds Cepheid Mpox Tests to Emergency-Use List

NEW YORK – The World Health Organization announced Wednesday that it has added a real-time PCR assay from Danaher subsidiary Cepheid to detect mpox, formerly known as monkeypox, to its Emergency Use Listing.

The WHO's Emergency Use Listing procedure is intended to enhance quality-assured testing options and is based on quality, safety, and performance data review in compliance with international standards while addressing the specific needs of low- and middle-income countries, the organization said in a statement.

The WHO listed the Cepheid Xpert Mpox tests under its EUL procedure on Oct. 25. The fully automated, cartridge-based, 40-minute test runs on GeneXpert systems and detects viral DNA of monkeypox virus clade II. The GeneXpert system is a near-point-of-care testing option, which can support decentralized testing, the WHO said.

The WHO previously listed the Roche Molecular Systems' Cobas MPXV assay under its EUL procedure on Oct. 14. That test runs on the Cobas 6800/8800 systems and detects mpox clades I and II in less than two hours. It can process multiple samples simultaneously and is suitable for clinical laboratories that handle large volumes of tests, the WHO said.

The WHO also previously listed the Abbott Molecular Alinity m MPXV assay under EUL on Oct. 3.

"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 Rogerio Gaspar, the WHO's director for regulation and prequalification.

The WHO declared a new mpox Public Health Emergency of International Concern on Aug. 14 following an upsurge in clade I cases primarily transmitted via nonsexual skin-to-skin contact among children in the Democratic Republic of Congo. The prior mpox PHEIC, declared in 2022, involved clade II mpox and was primarily transmitted through sexual contact.

More than 40,000 suspected mpox cases have been reported in 18 countries so far in 2024, with most remaining unconfirmed due to limited testing capacity, the WHO said.

Testing has increased significantly in the Democratic Republic of Congo, with support from WHO and partners, following efforts to decentralize testing. However, the proportion of tested cases still remains low, accounting for approximately half of the suspected cases.

The WHO said it 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," the WHO said.

The WHO called on mpox in vitro diagnostic manufacturers to submit expressions of interest for Emergency Use Listing on Aug. 28, 2024. In total, the WHO said it has received more than 60 expressions of interest for EUL review of mpox diagnostic tests since the PHEIC was declared. Seven of these progressed to EUL applications, with two products currently under review and two more expected soon, the organization said. The products under review are from CerTest Biotec and DiaCarta, according to the WHO's website.