PHASE Scientific Pioneers Urine-Based HPV Testing to Overcome Screening Barriers

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The initiative aims to demonstrate that non-invasive urine testing can match the accuracy of traditional cervical swabs while improving accessibility and compliance

Cervical cancer screening has long been hindered by barriers of discomfort, privacy concerns, and limited access, especially in regions with underdeveloped healthcare infrastructure. PHASE Scientific is tackling these challenges head-on with what is being hailed as the world’s largest clinical trial of urine-based HPV screening. Led by their proprietary PHASiFY technology, the initiative aims to demonstrate that non-invasive urine testing can match the accuracy of traditional cervical swabs while improving accessibility and compliance. In this exclusive interview, Ricky Chiu, Chairman and CEO of PHASE Scientific, shares how this groundbreaking approach, combined with AI-assisted colposcopy and urine methylation testing, is poised to transform cervical cancer prevention, both in China and globally, and how the synergy of vaccination and non-invasive screening could redefine women’s healthcare.

This study has been described as the world's largest clinical trial of urine-based HPV screening. What motivated PHASE Scientific to pursue such an ambitious initiative, and what impact do you hope it will have globally?

The biggest obstacles to cervical cancer screening have always been the pain, embarrassment, and accessibility that come with the traditional cervical swab. Urine-based testing powered by our core technology PHASiFY, addresses these challenges by being non-invasive, private, and easy to use – helping more women comply with screening recommendations and participate in routine screening.  With this study, we aim to demonstrate that urine testing can match gold-standard methods in accuracy, while being more acceptable to more women. Long-term, we see this approach not only transforming cervical cancer screening, but also paving the way for non-invasive testing in other cancers worldwide.

Urine-based testing has long faced challenges with sensitivity. How does PHASiFY technology improve detection accuracy, and what makes it different from other self-sampling approaches?

HPV DNA is typically present in very low amounts in urine, which historically limited test sensitivity. Our PHASiFY™ technology concentrates and purifies DNA by over 10,000-fold, significantly boosting detection performance. In the study collaborating with Peking University Shenzhen Hospital, our urine HPV test showed over 97 per cent concordance with clinician-collected samples analyzed by the Roche cobas® system. This research was awarded Best Clinical Research Abstract at the 2025 Annual Meeting of the American Society for Colposcopy and Cervical Pathology (ASCCP), highlighting its clinical reliability and global clinical relevance.

The study also integrates urine-based methylation testing and AI visual evaluation from colposcopy images. How do you see these innovations complementing each other in advancing cervical cancer screening?

These tools create a more personalized and efficient screening pathway. Urine methylation testing helps stratify risk, while AI-assisted colposcopy improves real-time clinical decision-making. Together, they support faster triage and point-of-care intervention, helping healthcare providers manage cases more effectively.

Accessibility is a key challenge in China, with screening coverage still far below the WHO's 70 per cent benchmark. How might urine-based self-sampling help overcome psychological, logistical, and cultural barriers for women?

Traditional cervical swab has been widely promoted in China and across the world for many years. However, the compliance rate has been less than ideal, which shows the limitation of existing methods. Urine-based self-sampling removes the key psychological and logistical barriers. It’s painless, private, and easy to self-collect. This makes it especially valuable for women in rural areas where access to clinical facilities is limited, or those hesitant to undergo vaginal sample collection, ultimately helping raise screening participation closer to the WHO’s 70 per cent target.

With HPV vaccination now included in China's national immunisation program, how do you see the dual approach of "vaccination + non-invasive screening" reshaping cervical cancer prevention strategies in the near future?

The rollout of free HPV vaccination for school-aged girls is a landmark step for China, but most women aged 25–65 remain unvaccinated and at risk. For this large population group, non-invasive screening remains critical. We believe vaccination + screening create a comprehensive prevention strategy that addresses both long- and short-term needs.

Beyond China, what are PHASE Scientific's plans for scaling or adapting this model internationally, especially in regions where screening infrastructure remains limited?

We’ve already launched our urine-based HPV testing in the US and Hong Kong. We’re open to explore partnerships to expand into other regions with limited screening infrastructure using our platform, so women everywhere have access to acceptable and reliable cervical cancer screening.