Urine-Based Cervical Cancer Screening Evaluated in World's Largest Study
The new study, based in China, will validate urine-based genetic methylation testing which concentrates trace amounts of HPV DNA by more than 10,000 times.
PHASE Scientific and Peking University Shenzhen Hospital have launched what they describe as the world’s largest clinical study of urine-based screening for cervical cancer.
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The prospective trial, based in Guang’an, Sichuan Province, will enroll 17,000 women to evaluate the performance of urine-based HPV DNA testing for detecting cervical intraepithelial neoplasia and cervical cancer. The study will be the first to validate urine-based methylation testing and artificial intelligence visual evaluation of colposcopy images within the same study cohort, according to a PHASE statement.
The urinalysis arm of the study will assess PHASE Scientific’s PHASiFY technology to determine whether the results are comparable to clinician-collected or vaginal self-collected samples. The proprietary technology concentrates trace 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 on the Roche Cobas platform, PHASE stated.
“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, Professor Wu Ruifang, Director of the National Cervical Cancer Early Detection and Treatment Demonstration Center at Peking University Shenzhen Hospital, and principal investigator of the study, said in a statement.
"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."
Ruifang emphasized the noninvasive nature of the collection, which women find more acceptable. He stressed the value of these benefits as "an important lever" to help increase rates of HPV screening participation.
The study coincides with China’s recent decision to include HPV vaccination in the national immunization program, offering free vaccines to school-aged girls. Experts note, however, that vaccination will take 10–20 years to influence incidence rates, while women aged 35–64 remain at highest risk. Thus, vaccination alone falls exceedingly short as a public health strategy against the short term disease burden, "making screening an irreplaceable tool in the current phase," according to the PHASE statement
According to the China CDC, current screening coverage for the vulnerable 35 to 64-year-old age group is 51.5%. This is well below the World Health Organization target of 70% by 2030, particularly in low- and middle income or rural settings where clinic-based screening has low reach.2
"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," Ruifang said.1
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.
References
PHASE Scientific launches world's largest urine-based cervical cancer (HPV) screening clinical study, marking new era of non-invasive cervical cancer screening. News release. PHASE Scientific. September 22, 2025. Accessed September 22, 2025. https://www.prnewswire.com/news-releases/phase-scientific-launches-worlds-largest-urine-based-cervical-cancer-hpv-screening-clinical-study-marking-new-era-of-non-invasive-cervical-cancer-screening-302562698.html
Bodur H, Erdem MO, Altinisik IAK, et al. Concentrated urine as an alternative to cervical smear samples enabling easy screening of HPV in large populations. J Infection Public Health. 2025;18(10):102857. doi:10.1016/j.jiph.2025.102857
Global strategy to accelerate the elimination of cervical cancer as a public health problem. World Health Organization. November 17, 2020. Accessed September 15, 2025. https://www.who.int/publications/i/item/9789240014107
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