WHO approves first mpox diagnostic test for emergency use [Globe and Mail, The (Toronto, Canada)]
Abbott Laboratories (ABT)
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Source: Globe and Mail, The
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 and U.S. diagnostics firm Labcorp 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 product
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