WHO approves first mpox diagnostic test for emergency use – National
THE World Health Organization approved Thursday the first mpox diagnostic test for emergency use to expand access to urgently needed medical testing.
The agency granted approval for emergency use of the Abbott Laboratories unit’s PCR test, the Alinity m MPXV test.
The test allows detection of mpox virus DNA from human skin lesion samples, the agency said, adding that it was designed for use by trained clinical laboratory personnel.
The agency said it is evaluating three new mpox diagnostic tests for its emergency use listing (EUL) and is also in discussions with other manufacturers to expand the availability of mpox diagnostic tools.
Swiss drugmaker Roche ROG.SandU.S. diagnostics company Labcorp LH.N is among the companies working to improve mpox laboratory testing capacity.
The EUL procedure is a risk-based assessment of unlicensed vaccines, therapeutics and diagnostics to expedite their availability in the event of a public health emergency.
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In August, WHO asked manufacturers to submit their products for emergency review and discussed with them the need for effective diagnostics, particularly in low-income groups.
—Reporting by Mariam Sunny and Akash Sriram in Bangalore; Editing by Mohammed Safi Shamsi
