PHASE Scientific launches world's largest urine-based cervical cancer study in Sichuan

PHASE Scientific International Ltd, headquartered in Hong Kong Special Administrative Region, has launched what is set to become the world's largest clinical study of urine-based cervical cancer screening, with the first site established in Guang'an, Sichuan province.

The study is led by Peking University Shenzhen Hospital, with participation from Guang'an People's Hospital and diagnostic support from PHASE Scientific. It will recruit 17,000 women to evaluate the effectiveness of urine-based human papillomavirus DNA testing for screening cervical cancer and cervical intraepithelial neoplasia.

The study sets three world records, namely the largest global clinical study on urine-based cervical cancer 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 study arrives just days after the National Health Commission announced on Sept 11 that cervical cancer vaccination will be included in the national immunization program, offering free vaccines to eligible girls.

The trial is powered by PHASiFY, PHASE Scientific's proprietary DNA concentration technology. It can amplify trace amounts of cervical cancer DNA in urine more than 10,000 times, achieving 93.42 percent sensitivity for high-risk HPV and over 97 percent concordance with clinician-collected swabs tested on the Roche Cobas system.

"Self-sampling technologies for cervical cancer screening have been validated globally for over 20 years," Wu Ruifang, the study's principal investigator and director of the national cervical cancer early detection and treatment demonstration center at the Peking University Shenzhen Hospital, said. "When combined with PHASiFY, urine-based testing can achieve sensitivity comparable to clinician-collected samples. It is non-invasive, convenient, and more acceptable to women, making it a powerful tool to boost screening coverage." 

The Peking University Shenzhen Hospital team recently presented these findings at the 2025 Annual Meeting of the American Society for Colposcopy and Cervical Pathology in the United States, winning the society's top clinical research award — the first time a Chinese team has received the honor.

"There are about 4 million women in Guang'an, with half in the target age group," Xiao Rongxing, deputy director of the Guang'an municipal health commission, said. "This project directly addresses the coverage gap and will make a meaningful impact on cervical cancer prevention in our city."

PHASE Scientific executives also stressed the broader potential. "With just a cup of urine, we can make screening more inclusive, accessible and precise," Jenny Chiu, vice-president of PHASE Scientific, said.

Gary Guan, general manager of PHASE Scientific China, added that the company is expanding its platform to include multi-disease detection from a single urine sample — covering sexually transmitted infections, and other cancers. "We are partnering with medical institutions, insurers, and digital health platforms to build full-spectrum solutions that integrate testing, intervention and prevention," he said.