The World Health Organization on Thursday approved the first variolapox (mpox) diagnostic test for emergency use to urgently expand access to medical testing.
The agency granted emergency use approval for Abbott Laboratories’ PCR test, the Alinity m MPXV assay.
The test allows detection of MOX virus DNA from swabs of human skin lesions, the agency said, adding that it is designed for use by trained clinical laboratory personnel.
The agency said it is evaluating three new mpox diagnostic tests for the Emergency Use Listing (EUL) and is also in discussions with other manufacturers to expand the availability of mpox diagnostic kits.
Swiss pharmaceutical company Roche ROG.SandU.S. Diagnostics company Labcorp LH.N is among the companies working to boost laboratory testing capacity for smallpox.
An EUL is a risk-based assessment of unlicensed vaccines, therapeutics, and diagnostics to accelerate their availability during public health emergencies.
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In August, the World Health Organization asked manufacturers to submit their products for emergency review, and held discussions with them about the need for effective diagnostics, especially in low-income groups.
—(Reporting by Maryam Sunny and Akash Sriram in Bengaluru – Prepared by Muhammad for the Arabic Bulletin) Investigation by Muhammad Safi Al Shamsi
