WHO Grants First Emergency Use Listing for US M-Pox Rapid Diagnostic Test

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The World Health Organization (WHO) has granted its first emergency approval for a test that can rapidly diagnose Mpox (formerly known as monkeypox), which is spreading primarily in Africa.

On the 4th (local time), WHO announced that it had approved the Mpox in vitro diagnostic test under the Emergency Use Listing (EUL) procedure.

The EUL is a system that allows the rapid use of medicines or diagnostic devices that have not yet received formal approval in urgent public health situations.

The test, developed by the U.S. biotech company Abbott Molecular, detects the virus by using real-time polymerase chain reaction (PCR) technology to examine swabs taken from the skin blisters of suspected Mpox patients.

As suspected Mpox cases surge rapidly but diagnostic capacity and resources lag behind, WHO appears to be swiftly promoting the dissemination of diagnostic technology.

According to WHO, in the Democratic Republic of the Congo, which has reported the highest number of Mpox cases this year, only 37% of suspected cases have undergone diagnostic testing.

WHO is expected to increase emergency approvals for diagnostic tests and devices.

This content was produced with the assistance of AI translation services.