WHO’s Prequalification of In Vitro Diagnostics

During the week of 27–31 October 2025, the World Health Organization (WHO) publ

Cowingene Monkeypox Typing Detection Kit, manufactured by Taizhou Cowingene Biotech Co., Ltd., has been listed under the WHO Emergency Use Listing (EUL).

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These assays - Aptima HPV 16 18/45 Genotype Assay and the Aptima HPV Assay provide advanced nucleic acid amplification technology for detecting high-risk HPV type

In September 2023, PQT/MED issued a call to manufacturers to revisit and update their risk assessments for Finished Pharmaceutical Products (FPP) containing APIs with vulnerable amine groups.

The PQT/AMD team has added a new product to the Emergency Use Listing (EUL):

During the week of 20–24 October 2025, the World Health Organization (WHO) published updates to several WHO’s Public Assessment Reports (WHOPARs) on its In Vitro Diagnostics (IV

In a continuing effort to best support the MPXV response, the Prequalification Unit has listed the Monkeypox Virus

The World Health Organization (WHO) has prequalified the Xpert MTB/XDR test, a quality-assured molecular diagnostic tool that enables rapid drug susceptibility testing (DST) for tuberculosis (TB).