By Ayomide Otitoju
The World Health Organization (WHO) has listed two new in vitro diagnostics for mpox under its Emergency Use Listing (EUL) procedure, broadening access to quality-assured testing options. This measure is aimed at improving the accuracy and availability of mpox diagnostics, particularly in low- and middle-income countries (LMICs).
The recently approved diagnostics include the Xpert Mpox PCR test by Cepheid, listed on 25 October, and the cobas MPXV assay by Roche Molecular Systems, Inc., added on 14 October. Both tests use Polymerase Chain Reaction (PCR), recognized as the gold standard for mpox diagnosis. The Xpert Mpox test delivers results in under 40 minutes using the GeneXpert system, which supports decentralized testing. Roche’s cobas MPXV assay, designed for high-volume laboratories, can detect both mpox clades in under two hours on the cobas 6800/8800 systems.
“Ensuring global access to mpox diagnostic tests that meet WHO standards is essential for effective testing in mpox-affected regions,” stated Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification, highlighting the need for prompt diagnosis and treatment to curb virus spread.
WHO previously listed the Alinity m MPXV assay by Abbott Molecular Inc. on 3 October. Efforts are ongoing to increase testing in affected areas, including the Democratic Republic of the Congo, where testing has risen with WHO support, although untested cases still make up nearly half of suspected infections.
The WHO is collaborating with manufacturers and national regulators to expedite access to these diagnostics, with fast-tracked approvals expected to streamline registration in impacted regions.
