PHASE Scientific International Limited (PHASE Scientific) announced the official launch of the world’s largest clinical study for urine-based cervical cancer (HPV) screening, with the first site established in Guang’an, Sichuan Province, China. This study is led by Peking University Shenzhen Hospital, with participation from West China Guang’an Hospital of Sichuan University and technical and diagnostic support by PHASE Scientific. The study applies PHASE Scientific’s proprietary PHASiFY urine-based DNA concentration technology, aiming to explore a scalable, accessible approach to cervical cancer prevention that delivers next-level public health impact with scientific innovation.

This prospective study plans to include 17,000 eligible women, evaluating the clinical performance of urine-based HPV DNA testing in primary screening settings for cervical intraepithelial neoplasia (CIN) and cervical cancer. Notably, it will also be the first in the world to validate urine-based methylation testing and artificial intelligence visual evaluation (AVE) from colposcopy images within the same cohort. The study sets three world records, namely the largest global clinical study on urine-based HPV subtyping for primary cervical cancer screening, the first and largest prospective study on urine-based genetic methylation testing for cervical cancer screening, and the first population validation in China of a handheld AI-enabled colposcopy device based on international standards.

By combining non-invasive sampling, high-efficiency molecular detection, and AI-powered diagnostics, the study aims to drive cervical cancer prevention into a new era of “vaccination + non-invasive screening.” Experts across the field believe this dual-track approach could provide valuable insights to help meet the World Health Organisation’s (WHO) 90-70-90 targets for cervical cancer elimination by 2030. The study also seeks to establish a practical and localised prevention model suited to China’s national context – one that improves screening accessibility and compliance.

On September 11, China’s State Council announced that HPV vaccination will be included in the national immunisation program, offering free vaccines to school-aged girls. While this policy milestone has raised national awareness about cervical cancer prevention, it also highlights new challenges: HPV vaccines cover only select virus types, and are most effective when administered before exposure, typically in younger, uninfected populations. The preventive impact on cervical cancer incidence could take 10-20 years to manifest. Meanwhile, women aged 35-64 remain the highest-risk group, and vaccination alone is unable to address the short-term disease burden, making screening an irreplaceable tool in the current phase.

However, traditional clinician-collected sampling often presents psychological and logistical barriers for many women. According to the Chinese Centre for Disease Control and Prevention (China CDC), the screening coverage rate among women aged 35-64 is only 51.5 per cent, far below the WHO’s 70 per cent benchmark. Thus, finding more accessible, non-invasive, and user-friendly screening methods has become a critical priority in advancing cervical cancer prevention.

Professor Wu Ruifang, Director of the National Cervical Cancer Early Detection and Treatment Demonstration Centre at Peking University Shenzhen Hospital, and the study’s principal investigator, said, “Self-sampling technologies for cervical cancer screening have been validated globally over the past two decades as effective tools to increase screening coverage. We will include urine-based HPV testing as an innovative self-sampling technology in this study. While other teams have explored this approach in the past, sensitivity has long been a challenge. Our previous research demonstrated that when paired with PHASiFY technology, urine-based HPV testing can achieve sensitivity comparable to clinician-collected and vaginal self-collected samples. We believe that urine testing is non-invasive, convenient, and more acceptable to women. This makes it an important lever for screening participation rate increase and public health policy implementation.”