How a Smart Urine Device is Transforming Cancer Screening
Imagine a cervical cancer screening that doesn't require a clinical appointment, doesn't involve uncomfortable procedures, and can be done in the privacy of your own home. This isn't science fiction—it's the promise of first-void urine collection technology that's poised to revolutionize how we detect cancer early.
As a woman, the thought of undergoing a cervical cancer screening can be daunting. The procedure is intimate, sometimes uncomfortable, and often comes with practical barriers like taking time off work, finding childcare, or simply mustering the courage to make that appointment. These challenges aren't just hypothetical—they contribute to significant gaps in screening coverage, particularly among underserved populations who need these services most 2 .
But what if we could detect the same high-risk human papillomavirus (hrHPV) infections that cause most cervical cancers through a simple urine sample? Recent advances in first-void urine (FVU) collection and molecular testing are turning this possibility into reality, offering a comfortable, accessible alternative that could transform cancer screening on a global scale 3 4 .
When it comes to detecting biomarkers associated with cervical cancer, the timing of urine collection matters significantly. First-void urine refers to the initial 20-40 mL of urine expelled at the beginning of urination. Unlike midstream samples traditionally used for urinary tract infection testing, this first flush contains the highest concentration of cellular debris and biomarkers that have accumulated in the urethra and, for women, the cervicovaginal tract 8 .
Think of it this way: as urine passes through the urethra, it acts like a cleansing stream, picking up cells, viruses, and other biological material along its path. The first portion of this stream naturally carries the richest concentration of diagnostically valuable material.
The Colli-Pee™ UAS™ 40mL represents a significant advancement over the humble urine cup. This isn't just a container—it's an engineered sampling system designed to overcome the limitations of traditional collection methods.
Unlike a regular cup where patients guess how much to provide, Colli-Pee™ automatically collects a standardized volume of first-void urine (available in 4mL, 10mL, 20mL, and 40mL configurations). This volumetric precision ensures consistent sample quality across different users, a critical factor for reliable diagnostic testing 8 .
The UAS™ (Urine Absorption Stabilization) system includes preservatives that stabilize biological markers at room temperature. This feature is particularly valuable for postal screening programs where samples may spend several days in transit before reaching the laboratory 8 .
The device is intentionally designed for easy, comfortable use without the need to interrupt urine flow—a significant advantage for individuals with mobility challenges or those who find midstream collection difficult 4 .
Illustrative medical collection device
Recent research has provided compelling evidence supporting the effectiveness of FVU-based screening. The CASUS study, conducted in Belgium, offers particularly insightful data on both the technical performance and user acceptance of this innovative approach 4 .
The CASUS researchers recruited 332 women aged 26-70 who were already scheduled for colposcopy referrals due to probable hrHPV infections or abnormal cervical lesions. Participants were asked to:
This design allowed for direct comparison between the self-collection method and the traditional clinician-collected approach while also gathering valuable feedback on user preferences and experiences 4 .
Participants: 332 women
Age Range: 26-70 years
Location: Belgium
Device: Colli-Pee™ UCM FV-5010
Comparison: Self-sampling vs. clinician-collected
The findings from the CASUS study were telling. When asked about their preferred method for future screening, a significant 66.6% of participants chose FVU self-sampling over physician-taken samples (32.9%) 4 .
| Screening Method | Preference Rate | Key Reasons |
|---|---|---|
| FVU Self-Sampling with Colli-Pee™ | 66.6% | Comfort, convenience, privacy |
| Physician-Taken Sample | 32.9% | Familiarity, trust in clinical setting |
| No Preference | 0.5% | - |
The usability data further reinforced the appeal of the self-sampling approach. Among the 210 women who completed the questionnaire:
Found the Colli-Pee™ device easy to use
Would use the device again
Preferred Colli-Pee™ over traditional cups
Beyond user preference, the critical question for any screening method is whether it works effectively. A 2025 U.S. study provided reassuring data on this front, demonstrating excellent agreement between FVU and clinician-collected samples 7 .
| HPV Type | Agreement Level | Kappa Statistic | Clinical Significance |
|---|---|---|---|
| HPV16 | Almost Perfect | 0.95 | Highest risk type for cervical cancer |
| HPV18 | Substantial | 0.78 | Another high-risk type |
| Other hrHPV Types | Substantial to Almost Perfect | 0.72-0.89 | Group of 12 additional high-risk types |
The research found that first-void urine collected with devices like Colli-Pee™ demonstrated similar sensitivity for detecting precancerous lesions compared to traditional speculum-based collection methods. This equivalence in detection performance, combined with significantly improved accessibility, presents a compelling case for incorporating FVU self-sampling into organized screening programs 7 .
Implementing a successful first-void urine screening program requires more than just a collection device. Here are the key components of the complete system:
| Component | Function | Examples/Options |
|---|---|---|
| Volumetric Collection Device | Standardized FVU collection | Colli-Pee™ (4mL, 10mL, 20mL, 40mL configurations) |
| Preservation Chemistry | Stabilizes biomarkers at room temperature | UAS™ preservative in Colli-Pee™ UAS™ |
| Molecular Assay Platform | Detects and genotypes hrHPV | Cobas® 4800 HPV Test, PCR-MassArray |
| Nucleic Acid Extraction Kits | Isolates DNA from urine samples | QIAamp DNA Micro Kit, QIAamp Viral RNA Mini Kit |
| Control Materials | Ensures assay accuracy and reliability | β-globin gene amplification for sample adequacy |
The implications of effective FVU self-sampling extend far beyond personal convenience. This technology has the potential to address significant disparities in cervical cancer screening participation across different populations.
Systematic reviews of cervical cancer screening barriers have identified multiple factors that contribute to low participation rates, particularly in low- and middle-income countries and among marginalized populations in high-income nations.
FVU self-sampling directly addresses many of these barriers by offering a private, non-invasive alternative that can be implemented without clinical visits.
The potential impact of accessible screening is particularly significant in low- and middle-income countries, which bear a disproportionate burden of cervical cancer mortality. In these regions, traditional cytology-based screening programs face substantial challenges related to infrastructure, trained personnel, and follow-up care .
Brazil, which recently approved hrHPV testing as the primary screening method, exemplifies how self-sampling could transform public health approaches to cervical cancer. As a country of "continental dimensions with significant socioeconomic disparities," Brazil represents the type of setting where FVU self-sampling could have tremendous impact 3 .
Recent Brazilian research demonstrated that both urine and vaginal self-collection methods were highly acceptable among women with high-grade cervical lesions, with urine sampling emerging as the preferred method. The study also found that instructional videos were particularly effective for guiding proper self-collection technique 3 .
The development of Colli-Pee™ and similar devices represents more than just incremental improvement in sample collection—it signals a fundamental shift toward patient-centered diagnostic approaches that prioritize accessibility, comfort, and convenience without compromising accuracy.
As research continues to refine our understanding of optimal implementation strategies, first-void urine sampling holds promise for expanding beyond HPV detection to other molecular targets, potentially creating screening opportunities for additional urogenital cancers and conditions.
The journey to eliminating cervical cancer as a public health problem requires multiple strategies, including HPV vaccination and effective treatment programs. But for the millions of women currently in need of screening, technologies like Colli-Pee™ offer something equally important: dignity, choice, and access to potentially life-saving detection.
The revolution in cancer screening won't necessarily happen in a doctor's office—it might just begin in your bathroom.