#China #Cervical Cancer #HPV Screening #PHASE Scientific #Guang'an

Introduction

In a significant step towards transforming cervical cancer screening, PHASE Scientific International Limited has launched the largest clinical study worldwide focused on urine-based screening for cervical cancer, specifically targeting HPV (human papillomavirus). This innovative approach, set to evaluate the clinical utility of urine samples, aims to shift the paradigm of cervical cancer prevention in an era defined by accessibility and non-invasiveness.

A Monumental Clinical Study

On September 22, 2025, PHASE Scientific officially announced the initiation of this groundbreaking study in Guang'an, Sichuan Province, China. Spearheaded by the Peking University Shenzhen Hospital, alongside the efforts of West China Guang'an Hospital of Sichuan University, this expansive research endeavor plans to involve 17,000 eligible females. By utilizing the patented PHASiFY™ technology, the study investigates urine-based HPV DNA testing as a primary screening method for cervical intraepithelial neoplasia (CIN) and cervical cancer.

This study not only encompasses the largest cohort for urine-based HPV screening globally but also pioneers the validation of urine-based methylation testing and artificial intelligence visual evaluation (AVE) derived from colposcopy images within the same group. These pioneering efforts create three world records in clinical research, including:
1. The largest global clinical trial focusing on urine-based HPV subtyping for primary cervical cancer screening.
2. The largest and first prospective study assessing urine-based genetic methylation testing for screening.
3. The first-ever population validation in China utilizing a handheld AI-powered colposcopy device meeting international standards.

Advancing Public Health

As global health authorities set ambitious targets to eliminate cervical cancer, the World Health Organization (WHO) has laid out its 90-70-90 strategy, emphasizing the importance of vaccination, screening, and treatment. The innovative study leads cervical cancer prevention efforts by combining non-invasive sampling, molecular detection technology, and AI-powered diagnostics into a cohesive approach. This dual focus of “vaccination + non-invasive screening” is anticipated to provide remarkable insights toward achieving WHO's ambitious objectives by 2030.

A recent policy announcement by China's State Council to include HPV vaccinations in the national immunization program aims to boost awareness. Yet, this presents challenges as current vaccines protect against only certain virus types and are most effective when administered to younger populations before exposure. As traditional methods remain prevalent, they pose logistical and psychological barriers that hinder screening uptake, particularly among the 35-64 age demographic, who bear the highest risk.

The screening coverage rate for this group in China is alarmingly low, at just 51.5%, significantly below the WHO's target of 70%. Therefore, developing accessible and non-invasive screening methodologies has now become fundamental to advancing cervical cancer prevention.

Exploring Urine-Based Testing

Professor Wu Ruifang, leading the clinical study, stresses the significance of self-sampling technologies that have shown great efficacy in increasing screening coverage globally. By introducing urine-based HPV testing as a self-sampling tool, the project aims to counteract previous hindrances, as sensitivity in urine testing had been a concern. However, earlier findings demonstrate that coupling this method with PHASiFY™ technology can yield sensitivity levels comparable to conventional clinician-collected samples. Offering a more user-friendly and non-invasive option, urine testing could greatly enhance participation rates in cervical screening initiatives, thus benefiting public health policies and outcomes.

The application of the PHASiFY™ technology concentrates minute traces of HPV DNA in urine samples, elevating sensitivity for identifying high-risk HPV strains to an impressive 93.42%, substantially matching results from clinician-collected vaginal swabs examined via the Roche Cobas system.

A Promising Future

The significance of this pioneering study has been underscored recently by accolades at the 2025 Annual Meeting of the American Society for Colposcopy and Cervical Pathology (ASCCP), where it received the Best Clinical Research Abstract Award - a first for a Chinese research team, demonstrating the international esteem of PHASiFY™'s clinical and scientific value. Local leaders, such as Xiao Rongxing from the Guang'an Municipal Health Commission, have voiced strong support for the initiative, considering the region's substantial female population and the pressing need to address existing screening gaps.

Jenny Chiu, PHASE Scientific’s Vice President, highlighted in her address that this clinical project represents a notable milestone in the evolution of non-invasive cervical cancer screening. The company is prepared to further invest in comprehensive self-sampling services, showcasing AP-powered colposcopy and cloud-based data platforms, all centered around advancing women's health and making diagnostics increasingly inclusive and accessible.

Moreover, with plans to launch other urine-based testing modalities for sexually transmitted infections (STIs) and additional diseases, PHASE Scientific aims to broaden the scope of its innovations in diagnostics and healthcare solutions.

Conclusion

As China stands on the brink of transformative changes in cervical cancer prevention and women's healthcare, the collaboration of innovative technologies and extensive research efforts with PHASE Scientific positions the organization as a leader in pioneer advancements. Together, we can bridge the gap between vaccination programs and effective screening strategies, collectively paving the way for healthier futures and contributing to the broader global health objectives, including the Healthy China 2030 vision.