PHASE Scientific International Limited has officially launched the world's largest clinical study for urine-based cervical cancer screening, marking a significant advancement in non-invasive HPV detection technology. The prospective study, established in Guang'an, Sichuan Province, China, plans to enroll 17,000 eligible women to evaluate the clinical performance of urine-based HPV DNA testing in primary screening settings.
Groundbreaking Study Design Sets Multiple World Records
The study, led by Peking University Shenzhen Hospital with participation from West China Guang'an Hospital of Sichuan University, establishes three world records simultaneously. It represents 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.
The research will evaluate urine-based HPV DNA testing for detecting cervical intraepithelial neoplasia (CIN) and cervical cancer, while also validating urine-based methylation testing and artificial intelligence visual evaluation from colposcopy images within the same cohort.
PHASiFY™ Technology Demonstrates High Sensitivity
The study utilizes PHASE Scientific's proprietary PHASiFY™ technology, which concentrates trace amounts of HPV DNA in urine by more than 10,000 times. Previous research has demonstrated that the technology achieves 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.
Addressing Critical Screening Coverage Gaps
The study addresses a significant public health challenge in China, where screening coverage among women aged 35-64 is only 51.5%, according to the Chinese Center for Disease Control and Prevention. This falls far below the World Health Organization's 70% benchmark for cervical cancer elimination targets by 2030.
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 the clinical rationale: "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."
Wu noted that while other teams have explored urine-based approaches previously, 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," she stated.
Strategic Timing with National Policy Changes
The study launch coincides with China's State Council announcement on September 11 that HPV vaccination will be included in the national immunization program, offering free vaccines to school-aged girls. However, experts note that HPV vaccines cover only select virus types and are most effective when administered before exposure. The preventive impact on cervical cancer incidence could take 10-20 years to manifest, while women aged 35-64 remain the highest-risk group.
Xiao Rongxing, Deputy Director of the Guang'an Municipal Health Commission, highlighted the local significance: "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."
Comprehensive Technology Platform
Beyond HPV detection, PHASE Scientific is developing a multi-disease detection platform from single urine samples. Gary Guan, General Manager of PHASE Scientific China, explained: "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."
The company is also advancing screening capabilities for sexually transmitted infections and other cancers simultaneously from the same urine sample, while partnering with medical institutions, health checkup providers, insurers, and online platforms to improve access to testing.
Clinical and Commercial Validation
PHASE Scientific's products and services have received certifications from the U.S. Food and Drug Administration, European Union CE, and regulatory agencies in various countries, providing over 100 million testing products and services in more than 30 countries worldwide. The company recently completed a $34 million Series A funding round, representing the largest Series A raise in Asia's diagnostic technology sector since 2019, with support from the Gates Foundation and U.S. governmental agencies including the National Science Foundation and National Institute of Health.
