We are excited to share that the BioPerfectus Monkeypox Virus (MPXV) Fast Real Time PCR Kit has been officially listed under the WHO Emergency Use Listing (EUL) as of December 3, 2025.
This designation signifies that the product is now formally recognized for procurement and use by WHO Member States and other interested purchasers. Following its inclusion in the Global Fund’s list of mpox molecular diagnostics that meet quality assurance standards, this marks another significant international recognition of BioPerfectus mpox testing solutions.
The WHO EUL is a mechanism designed to assess the suitability of new health products during public health emergencies, enabling the rapid deployment of medicines, vaccines, and diagnostic tools when urgent response is needed. Being listed under the EUL indicates that the product meets WHO’s international standards for safety, performance, and quality.
Achieving this qualification strengthens BioPerfectus ability to contribute more critically to global mpox prevention and control efforts. It also reflects the increasingly important role that Chinese in vitro diagnostic manufacturers are playing in advancing global public health.
BioPerfectus is one of the leading global suppliers of mpox diagnostic tests, offering assays across two technological platforms—real-time fluorescent PCR and droplet digital PCR. The product portfolio includes F3L single-target, F3L+B7R dual-target, and genotyping assays, enabling rapid and accurate detection of mpox virus in skin lesion specimens (such as swabs of rashes or vesicle exudate, vesicle fluid, and crusts), as well as in throat swabs, whole blood, or serum samples. Multiple assays have already received CE marking in the European Union and MHRA approval in the United Kingdom.
From being included in the Africa CDC’s first recommended product list, to meeting the Global Fund’s quality assurance standards for mpox molecular diagnostics, and now being listed under the WHO Emergency Use Listing (EUL) — this series of international recognitions not only reflects the continued confidence global health organizations have in BioPerfectus product performance, but also serves as a passport for the product’s entry into more international markets.
Looking ahead, BioPerfectus will continue to uphold its mission and remain committed to its global strategy. We will consistently deliver high-quality diagnostic solutions and provide timely and accurate testing tools for mpox and other emerging infectious diseases—contributing Chinese expertise and solutions to global health.
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