PHASE Scientific Launches World's Largest Urine-Based Cervical Cancer (HPV) Screening Clinical Study, Marking New Era of Non-Invasive Cervical Cancer Screening
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.
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 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 often 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-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 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 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."
Professor Wu continues, "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."
The study utilizes PHASE Scientific's proprietary PHASiFY™ technology, which concentrates trace amounts of HPV DNA in urine by more than 10,000 times, achieving 93.42% sensitivity for high-risk HPV detection, and over 97% concordance with clinician-collected vaginal swabs analyzed using the Roche Cobas system. This research, led by the Peking University Shenzhen Hospital team, was recently recognized with the Best Clinical Research Abstract Award at the 2025 Annual Meeting of the American Society for Colposcopy and Cervical Pathology (ASCCP) – the society's highest honor, and the first time a Chinese research team has received this distinction, underscoring the international recognition of PHASiFY™'s scientific and clinical value.
Xiao Rongxing, Deputy Director of the Guang'an Municipal Health Commission, commented on the significance of the study at Guang'an, "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, stated during her speech in the kick-off 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 the company's plans on the Chinese mainland, 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."
"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." Gary added.
From the inclusion of HPV vaccines in the national immunization program to the simultaneous achievement of three world records, PHASE Scientific is bridging the gap between "the first shot of the vaccine" and "the last mile of diagnostics" – leading the global shift toward non-invasive cervical cancer screening powered by its innovation. With aligned progress in technology, research, and distribution, PHASE Scientific helps to reshape global cervical cancer prevention and contribute to the Healthy China 2030 vision.
*Note to editor: The WHO's Global Strategy to Accelerate the Elimination of Cervical Cancer sets a threshold for all countries of an incidence rate of less than 4 cases per 100,000 women. It also establishes the following targets to be achieved by 2030 in all countries: 90% HPV vaccination coverage, 70% screening coverage, and 90% access to treatment for cervical pre-cancer and cancer, including access to palliative care.
About PHASE Scientific
PHASE Scientific International Limited ("PHASE Scientific") is a fast-growing biotech company with a mission to inspire a new state of health through innovative diagnostics and healthcare solutions. With operations in the U.S., mainland China, and Hong Kong SAR, PHASE delivers novel diagnostic tools and services for cancer and infectious diseases using proprietary technologies, empowering better disease detection, diagnosis, and management.
PHASE Scientific's products and services have received certifications from the U.S. Food and Drug Administration (FDA), the European Union CE, and regulatory agencies in various countries, providing over 100 million testing products and services in more than 30 countries worldwide.
PHASE Scientific has recently completed a US$34 million Series A funding round, representing the largest Series A raise in Asia's diagnostic technology sector since 2019. Other supporters include Gates Foundation, and US governmental agencies National Science Foundation and National Institute of Health. For more information, please visit phasescientific.com.
About PHASIFY™
PHASIFY™ is the world's first urine concentration technology designed for molecular diagnostics, setting a new industry benchmark by capturing approximately 10 times more target analytes from urine specimens compared to the current gold standard. This advanced mechanism enables the concentration and purification of unlimited volumes of urine, dramatically increasing the sensitivity and accuracy of disease detection.
This proprietary innovation uniquely positions PHASE Scientific as the only player in the urine-based liquid biopsy diagnostics field, with proven clinical performance for multi-cancer detection. With a non-invasive and painless approach, PHASIFY™ empowers convenient sample collection, unlocking new possibilities for early, accessible, and comprehensive disease screening and diagnosis.
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