First And Largest Prospective Study of Urine-Based Genetic Methylation Testing for Cervical Cancer Screening

While human papillomavirus (HPV) vaccination programs are expanding globally, they cannot address the immediate burden of disease, as vaccines are most effective before exposure and their impact takes years to manifest. Screening remains essential, yet traditional clinician-collected sampling poses psychological and logistical barriers, leaving coverage far below the WHO’s recommended levels. Now, a new clinical study marks a new era of non-invasive cervical cancer screening.

PHASE Scientific (Hong Kong, China) has launched the world’s largest clinical study on urine-based cervical cancer screening, supported by Peking University Shenzhen Hospital (Shenzhen, China) and collaborators. The study applies PHASE Scientific’s proprietary PHASiFY urine-based DNA concentration technology, alongside genetic methylation testing and artificial intelligence (AI) visual evaluation of colposcopy images. With 17,000 participants, it aims to validate urine-based HPV testing as a scalable, accessible alternative to current methods.

This prospective trial will assess the accuracy of urine-based HPV DNA testing in detecting cervical intraepithelial neoplasia and cancer. It sets three records: the largest global clinical study of urine-based HPV subtyping, the first and largest prospective study of urine-based methylation testing, and the first population validation of an AI-enabled handheld colposcopy device in China. Together, these innovations represent a major step toward combining vaccination with non-invasive screening for prevention.

The PHASiFY technology, central to the study, can concentrate HPV DNA in urine samples over 10,000 times, achieving 93.42% sensitivity for high-risk HPV detection and 97% concordance with clinician-collected samples. The approach has already been recognized internationally, earning the Best Clinical Research Abstract Award at the 2025 Annual Meeting of the American Society for Colposcopy and Cervical Pathology. These results highlight the clinical reliability and global impact of this platform.

Experts believe urine-based screening could overcome long-standing barriers, increasing participation and supporting the WHO’s 90-70-90 cervical cancer elimination goals. The study also seeks to create a prevention model tailored to China’s healthcare system, where coverage gaps remain, particularly among older women. PHASE Scientific plans to extend the technology to multi-disease detection, expanding from cervical cancer to sexually transmitted infections (STIs) and other cancers through a single urine sample.

“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,” said Professor Wu Ruifang, principal investigator of the study. “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.”

Related Links:
PHASE Scientific
Peking University Shenzhen Hospital