PHASE Scientific International Limited has launched the world’s largest clinical trial focused on urine-based cervical cancer screening. The first study site is located in Guang’an, Sichuan Province, China. This research is led by Peking University Shenzhen Hospital, in collaboration with West China Guang’an Hospital of Sichuan University, and supported by PHASE Scientific’s proprietary PHASiFY™ technology. The technology concentrates HPV DNA in urine samples to offer a scalable, accessible method for cervical cancer prevention driven by scientific innovation.
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The study aims to enroll 17,000 women to evaluate the effectiveness of urine-based HPV DNA testing for primary screening of cervical intraepithelial neoplasia and cervical cancer. It is also the first global effort to validate urine-based methylation testing alongside artificial intelligence-assisted visual analysis from colposcopy images in the same patient group. The study sets three world records: the largest global trial on urine-based HPV subtyping, the first and largest prospective study on urine-based genetic methylation testing, and the first population validation in China of a handheld AI-enabled colposcopy device that meets international standards.
By combining a non-invasive urine collection process, advanced molecular detection methods, and AI-powered diagnostics, the research seeks to usher cervical cancer prevention into a new era that integrates vaccination and screening. Experts believe this approach will help countries meet the World Health Organization’s 90-70-90 targets for cervical cancer elimination by 2030. The study also aims to create a practical prevention model tailored to China’s healthcare system to improve access and participation in screening.
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Professor Wu Ruifang, Director of the National Cervical Cancer Early Detection and Treatment Demonstration Center at Peking University Shenzhen Hospital and the study’s principal investigator, highlighted that self-sampling methods have proven effective worldwide in increasing screening coverage. She noted that urine-based HPV testing with PHASiFY™ technology matches the sensitivity of clinician-collected samples. The non-invasive and user-friendly nature of this method makes it critical for improving participation in cervical cancer screening programs. Wu also stressed that the study will provide important data to support future national guidelines and standards.
PHASiFY technology can concentrate HPV DNA in urine by more than 10,000 times, achieving over 93 percent sensitivity for high-risk HPV detection and more than 97 percent agreement with clinician-collected vaginal swabs analyzed using the Roche Cobas system. The technology recently received the Best Clinical Research Abstract Award at the 2025 American Society for Colposcopy and Cervical Pathology Annual Meeting, the highest honor of the society and a first for a Chinese research team.
Xiao Rongxing, Deputy Director of the Guang’an Municipal Health Commission, noted the large number of eligible women in the area and said the study will significantly impact cervical cancer prevention locally. Jenny Chiu, Vice President of PHASE Scientific, expressed optimism, stating the project marks a major milestone for non-invasive screening. She outlined plans to expand self-sampling services including urine-based HPV testing, AI-powered colposcopy, and cloud data platforms. Gary Guan, General Manager of PHASE Scientific China, shared the company’s vision to extend PHASiFY™ technology beyond cervical cancer to detect other diseases. PHASE is actively partnering with healthcare providers, insurers, elder care facilities, and online platforms to increase public health education and testing access, aiming to provide accurate and convenient diagnostics while building a comprehensive health solution integrating screening, intervention, and prevention.
Following China’s recent inclusion of HPV vaccination in the national immunization program, PHASE Scientific is working to bridge the gap between vaccination coverage and effective screening. By setting three world records and advancing technology, research, and partnerships, PHASE Scientific is leading the global move toward non-invasive cervical cancer screening and contributing to the Healthy China 2030 vision.
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