WHO approves first mpox diagnostic test for emergency use
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The World Health Organization (WHO) has authorized the first mpox in vitro diagnostic test for emergency use in an effort to expand diagnostic capacity in countries facing mpox outbreak.
The agency approved the emergency use of the Alinity m MPXV assay, manufactured by Abbott Molecular (NYSE:ABT), as an important step in improving global access to mpox testing.
The Alinity m MPXV assay is a real-time PCR test that enables detection of monkeypox virus (clade I/II) DNA from human skin lesion swabs.
“This first mpox diagnostic test listed under the Emergency Use Listing procedure represents a significant milestone in expanding testing availability in affected countries,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products.
The WHO said it has received three additional submissions for emergency use evaluation, and is currently in discussions with other manufacturers of mpox IVDs to ensure a wider range of quality-assured diagnostic options.
Potentially relevant Mpox test makers include, Virax Biolabs (VRAX), Applied DNA Sciences (APDN), Co-Diagnostics (CODX), Roche (OTCQX:RHHBY) (OTCQX:RHHBF) and Labcorp Holdings (LH).
The organization declared mpox a global public health emergency for the second time in two years in August, following an outbreak of the disease in the Democratic Republic of Congo.