PHASE Scientific International Limited has announced the launch of the world’s largest clinical study on urine-based cervical cancer (HPV) screening, with the first study site established in Guang’an, Sichuan Province, China.
The prospective study is being led by Peking University Shenzhen Hospital, in collaboration with West China Guang’an Hospital of Sichuan University, with technical and diagnostic support from PHASE Scientific. At the core of the study is PHASE Scientific’s proprietary PHASiFY™ urine-based DNA concentration technology, aimed at building a scalable, accessible prevention model that enhances cervical cancer screening through innovation.
The study plans to recruit 17,000 women, assessing the clinical performance of urine-based HPV DNA testing in primary screening for cervical intraepithelial neoplasia (CIN) and cervical cancer. It will also be the first global validation of urine-based methylation testing and AI-powered colposcopy visual evaluation (AVE) within the same cohort. This initiative sets three world records:
Largest global clinical study on urine-based HPV subtyping for cervical cancer screening
First and largest prospective study on urine-based genetic methylation testing for cervical cancer screening
First population-based validation in China of a handheld AI-enabled colposcopy device built on international standards
By integrating non-invasive urine sampling, advanced molecular diagnostics, and AI-powered imaging, the study aims to redefine cervical cancer prevention under the dual strategy of “vaccination + non-invasive screening.” Experts believe this approach will help accelerate progress toward the WHO’s 90-70-90 targets for eliminating cervical cancer by 2030.
On September 11, China’s State Council announced that HPV vaccination will be included in the national immunization program, providing free vaccines to school-aged girls. While a major step forward, vaccination alone cannot immediately reduce cervical cancer incidence, as the benefits may take 10–20 years to appear. Women aged 35–64 remain the highest-risk group, underscoring the need for accessible screening methods to complement vaccination efforts.
Currently, China’s CDC reports a cervical cancer screening coverage of only 51.5% among women in the target age group, significantly lower than the WHO’s 70% benchmark, due in part to psychological and logistical barriers in clinician-based sampling.
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, explained:
“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.”
She added:
“This study represents a unique combination of technology, scientific research and public health. It will not only benefit a broad female population, but also provide vital real-world data to support the development of national cervical cancer prevention guidelines and self-sampling standards.”
PHASiFY™ technology can concentrate trace amounts of HPV DNA in urine by over 10,000 times, achieving 93.42% sensitivity for high-risk HPV detection and 97% concordance with clinician-collected vaginal swabs tested on the Roche Cobas system. The research team’s work was recently awarded the Best Clinical Research Abstract Award at the 2025 Annual Meeting of the American Society for Colposcopy and Cervical Pathology (ASCCP)—the first time a Chinese team has received this top honor.
Xiao Rongxing, Deputy Director of the Guang’an Municipal Health Commission, emphasized the study’s impact:
“There are around 4 million women in Guang’an, with around 2 million of them in the target age group for HPV screening. However, there remains a screening coverage gap for women living in urban areas besides the low-income groups. This clinical study directly addresses that gap and will have a significant impact on cervical cancer prevention in our city.”
Jenny Chiu, Vice President of PHASE Scientific, highlighted the milestone at the launch ceremony:
“This project is a major milestone in the advancement of non-invasive cervical cancer screening. PHASE Scientific will invest in rolling out comprehensive self-sampling services, including urine-based HPV testing, AI-powered colposcopy, and cloud-based data platforms. We believe that with just a cup of urine, we can drive a future of more inclusive, accessible and precise healthcare for women.”
Speaking on local plans, Gary Guan, General Manager of PHASE Scientific China, said:
“At the core of our PHASiFY™ platform is biomarker concentration from clinical samples – a technology that can be applied to many diseases. In China, we've launched both male and female versions of the urine-based HPV testing, along with a full-suite of cervical cancer and HPV prevention solutions. We're also advancing multi-disease detection from a single urine sample, enabling screening for sexually transmitted infections (STIs) and other cancers at the same time.”
He added:
“We are actively partnering with medical institutions, health checkup providers, insurers, elder care providers, and online platforms to drive public health education and promote access to testing. Our goal is to provide users with convenient, accurate diagnostics, and to build a full-spectrum health solution that integrates testing, intervention, and prevention.”
From the inclusion of HPV vaccines in the national program to the simultaneous achievement of three world records, PHASE Scientific is positioning itself as a global leader in advancing non-invasive cervical cancer screening. By linking vaccination with innovative diagnostics, the company is contributing to both the Healthy China 2030 vision and the global fight to eliminate cervical cancer.