BD announced that its Onclarity HPV assay, designed for the BD COR and BD Viper LT systems, has received World Health Organization prequalification as of November 17 2025. The assay detects 14 high‑risk HPV types, including individual identification of six high‑risk types and three genotype groups, and supports self‑collection, including at‑home sampling in countries that recognize the CE mark. WHO prequalification is a rigorous endorsement that allows the test to be incorporated into national screening programs, especially in low‑ and middle‑income countries where cervical‑cancer screening is limited.
BD’s recent financial results underscore the strategic importance of the prequalification. In the fourth quarter of fiscal 2024, the company reported revenue of $5.4 billion, up 6.9 % from the prior year, and adjusted diluted earnings per share of $3.68, a 7.6 % increase. For fiscal 2025, BD projected revenue growth of 8.9 %–9.4 % and adjusted EPS growth of around 10 %. The strong performance is driven by robust demand in the Medical, Life Sciences, and Interventional segments, with the Medical segment up 11.1 % in Q4 FY24 and the Interventional segment up 4.7 %. These results demonstrate the company’s ability to generate incremental revenue from new product approvals while maintaining margin expansion.
Nikos Pavlidis, BD’s worldwide president of Diagnostic Solutions, said the prequalification “is an important step toward changing the future of cervical cancer screening, especially in low‑ and middle‑income countries where the burden is greatest and access to screening is often limited.” Tom Polen, CEO, added that the approval “reinforces BD’s leadership in cervical‑cancer diagnostics and aligns with our strategy to focus on high‑growth, high‑impact areas.” The comments highlight BD’s intent to leverage the prequalification to accelerate market penetration and support global health goals.
The prequalification opens BD’s assay to procurement by UN agencies and other international organizations that rely on WHO‑endorsed diagnostics. WHO estimates that cervical cancer causes 311,000 deaths worldwide each year, with the majority occurring in low‑ and middle‑income countries. By enabling self‑collection and at‑home sampling, the Onclarity assay can reach an estimated 100 million women in these regions who currently lack access to routine screening. The expanded reach aligns with WHO’s goal of eliminating cervical cancer as a public‑health problem by 2030.
From a business perspective, the prequalification is expected to generate incremental revenue and strengthen BD’s competitive position in the high‑risk HPV testing segment. The assay’s extended genotyping capability and compatibility with BD’s existing platforms position it favorably against competitors that offer limited genotyping. The approval also supports BD’s “BD 2025” strategy, which prioritizes high‑growth diagnostics and operational efficiency. While the company has not yet quantified the revenue impact, the expanded market access is likely to translate into higher sales volumes in public‑health settings and reinforce BD’s leadership in global cervical‑cancer diagnostics.
In summary, the WHO prequalification of the Onclarity HPV assay marks a significant regulatory milestone that expands BD’s global footprint, supports public‑health initiatives, and aligns with the company’s growth strategy. The event is expected to reinforce BD’s market leadership and contribute to the company’s strong financial trajectory in the coming years.
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