Human papillomavirus (HPV) remains one of the most prevalent sexually transmitted infections globally, significantly contributing to cervical cancer. While established screening programs have successfully reduced cervical cancer incidence and mortality, barriers such as cultural sensitivities, logistical challenges, and the invasive nature of traditional procedures continue to limit widespread participation.
A promising alternative gaining scientific attention is first-void urine (FVU), the initial portion of urine expelled at the start of urination. Unlike mid-stream urine, commonly collected to reduce contamination in urinary tract testing, FVU is enriched with epithelial cells, nucleic acids, and other biomarkers from the lower urinary tract. This feature makes FVU a compelling non-invasive sample type for infectious disease detection, oncology research, and emerging drug discovery applications.
Understanding First-Void Urine
Dr. Tara Crawford Parks, PhD, Director of Translational R&D at DNA Genotek™, explains that the first 50 milliliters of urine contains high concentrations of biomarkers such as epithelial cells, mucus, extracellular vesicles, DNA, RNA, proteins, and metabolites. These components provide a molecular snapshot of infection, inflammation, or early disease processes, offering researchers a non-invasive window into cellular changes that could guide therapeutic strategies.
The World Health Organization already recommends FVU for nucleic acid amplification tests targeting Chlamydia trachomatis and Neisseria gonorrhoeae. Its biomarker richness now positions it as a viable candidate for HPV detection and broader oncology research.
Standardizing Collection with the Colli-Pee™ Device
Collecting FVU accurately with a standard urine cup is challenging. Because the most diagnostically relevant material is concentrated in the very first fraction, improper collection risks sample dilution or loss. The Colli-Pee™ device addresses this by channeling urine into a collection tube until a preset volume is achieved, after which excess urine is diverted. This ensures reproducible volumes across formats (4mL, 10mL, 20mL, 40mL), making self-collection feasible and discreet outside clinical settings.
Beyond HPV: Expanding Research Potential
FVU contains diverse analytes, including cell-free DNA, RNA, proteins, and metabolites, supporting applications across genomics, transcriptomics, proteomics, and metabolomics. It shows promise in early detection of cancers such as prostate, breast, and endometrial, as well as monitoring disease recurrence. Its non-invasive nature also opens doors for women’s health conditions, including endometriosis, while supporting multiomic data collection critical for drug discovery and biomarker validation.
Stabilizing Samples for Reliable Analysis
Urine begins to degrade soon after collection, compromising DNA and RNA integrity. The Colli-Pee™ UCM preservative stabilizes nucleic acids at room temperature for up to seven days, eliminating the need for cold-chain transport and simplifying large-scale studies. This stability enhances the reliability of biomarker research and clinical trials across diverse populations.
Clinical Evidence Supporting HPV Detection
Multiple studies, including VALHUDES, Predictors 5.1, CoCoss, and CASUS, demonstrate that FVU-based high-risk HPV testing performs comparably to clinician-collected cervical samples. Importantly, these studies highlight strong patient preference for self-collection, particularly for individuals with cultural sensitivities or prior trauma. The CASUS study found that over two-thirds of participants preferred home-based FVU collection, with 96% finding the process easy to perform and willing to repeat it.
Enhancing Accessibility and Equity
Non-invasive self-collection reduces physical, psychological, and logistical barriers, particularly for underserved populations. FVU empowers individuals to participate in screening without travel or clinic visits, streamlines workflows, and reduces costs, supporting equity in healthcare access. For drug discovery, broader sampling enhances biomarker diversity and accelerates translational research.
Conclusion
First-void urine represents a significant innovation in screening and diagnostics. Standardized, preservative-stabilized collection through devices like the Colli-Pee™ ensures reliable molecular analysis while maximizing patient comfort and participation. Evidence supports its non-inferiority for HPV testing and potential for broader oncology and women’s health applications. By reducing disparities and simplifying processes, FVU may redefine the future of cervical cancer screenings and precision medicine.
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