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