PHASE Scientific Launches World’s Largest Clinical Study for Urine-Based Cervical Cancer Screening in China
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GUANG’AN, china, Sept. 22, 2025 /PRNewswire/ — PHASE Scientific International Limited (“PHASE Scientific”) today 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.
The 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 Organization’s (WHO) 90-70-90 targets for cervical cancer elimination by 2030. The study also seeks to establish a practical and localized 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 immunization 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 ofen presents psychological and logistical barriers for many women.According to the Chinese Center for Disease Control and Prevention (China CDC), the screening coverage rate among women aged 35-64 is only 51.5%, far below the WHO’s 70% benchmark. Thus, finding more accessible, non-invasive, and user-amiable 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 Exhibition Center 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
PHASE Scientific’s PHASIFY™ Technology Revolutionizes Urine-Based Liquid Biopsy Diagnostics
PHASIFY™ is a groundbreaking urine concentration technology developed by PHASE Scientific that considerably enhances the sensitivity and accuracy of molecular diagnostics. Representing a major advancement over current methods, PHASIFY™ captures approximately 10 times more target analytes from urine samples, enabling earlier and more accessible disease detection.this innovation positions PHASE Scientific as a leader in the emerging field of urine-based liquid biopsies,particularly for multi-cancer detection.
Understanding PHASIFY™ and its Advantages
Traditional methods of analyzing urine for biomarkers often struggle with low analyte concentrations, limiting thier effectiveness. PHASIFY™ addresses this challenge by concentrating and purifying urine samples, even in large volumes.This process dramatically improves the ability to detect disease indicators, offering several key advantages:
* Increased Sensitivity: By concentrating the sample, PHASIFY™ allows for the detection of even minute quantities of biomarkers, potentially identifying diseases at earlier stages.
* Improved Accuracy: purification of the sample reduces interference, leading to more reliable and accurate diagnostic results.
* non-Invasive Sample Collection: Urine collection is a simple, painless, and convenient process for patients, increasing compliance and accessibility to screening.
* unlimited Volume Processing: The technology can process unlimited volumes of urine,further enhancing the concentration of target analytes.
The Rise of Urine-Based Liquid Biopsies
Liquid biopsies, which analyze biomarkers in bodily fluids like blood or urine, are gaining prominence as a less invasive alternative to traditional tissue biopsies. Urine-based liquid biopsies, in particular, offer unique advantages due to the ease of collection and the presence of biomarkers shed from the urinary tract and other organs. PHASE Scientific’s PHASIFY™ technology is at the forefront of this innovation, enabling more effective and reliable urine-based diagnostics. https://phasescientific.com/technology/phasify/
Clinical Performance and Multi-Cancer Detection
PHASE Scientific highlights the proven clinical performance of PHASIFY™ in multi-cancer detection. While specific details of clinical trials are proprietary, the company emphasizes its unique position in the urine-based liquid biopsy market. The technology’s ability to enhance biomarker detection is crucial for identifying multiple cancer types from a single urine sample, potentially revolutionizing cancer screening programs.
Looking Ahead
PHASIFY™ represents a meaningful step forward in early disease detection and diagnosis. By empowering convenient sample collection and dramatically improving diagnostic accuracy, PHASE Scientific is unlocking new possibilities for accessible and complete health screening. As research continues and the technology is further validated through clinical trials, PHASIFY™ is poised to play a pivotal role in the future of liquid biopsy diagnostics and personalized medicine.
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SOURCE PHASE Scientific