Abstract C025: Colli-Pee™ UAS™ 40mL: A first-void urine collection device with potential to improve access to cancer screening when paired with an appropriate clinical assay

Abstract

Abstract In recent years, liquid biopsy has become increasingly important for cancer screening, detection and monitoring as cancer-specific biomarkers can be captured non-invasively in biological fluids. First-void urine (FVU) offers distinct advantages, such as ease of collection and large available volumes. Colli-Pee™ UAS™ 40 mL is a FVU self-collection device pre-filled with UAS, a non-lytic liquid preservative. Usability questionnaires from 98 healthy and diseased users showed that Colli-Pee™ was clear (90%) and comfortable (68%) to use, underscoring its potential to improve access to cancer screening for underserved communities. Here, we evaluated the performance of the device for FVU collection and urinary analyte preservation. FVU samples were collected from healthy donors with the Colli-Pee™ UAS 40 mL device to evaluate analyte preservation (n=14). Samples were stored at room temperature (RT), with aliquots processed at baseline and 8 days, or after freeze/thaw cycling (-20°C/-4°F to 40°C/104°F) to simulate ambient temperature transport. Cell-free DNA (cfDNA, Qiagen Circulating Nucleic Acid Kit) and extracellular vesicle RNA (EV RNA, Qiagen exoRNeasy Maxi Kit) were extracted from sample supernatants and evaluated for analyte preservation via qPCR assays targeting the β-globin gene (cfDNA) or the GAPDH mRNA (EV RNA). Cellular pellets were obtained at each time point by centrifugation and genomic DNA was extracted (Qiagen PowerFecal Pro DNA Kit) to evaluate both host cell integrity and microbial growth. Both were inferred based on the amount of change in qPCR signal for a human DNA target (TS143) and a non-specific bacterial target (16S). Data are presented as mean ± SD. Analysis of RT-stored samples confirmed that both urinary cfDNA and EV RNA were well preserved (ΔCt: 0.01 ± 1.04 and 0.58 ± 1.15, respectively). Similarly, qPCR of host and microbial DNA recovered from the cellular pellet showed no change after storage (ΔCt: 0.00 ± 0.50 and 0.06 ± 0.51, respectively), demonstrating that host cells remained intact and that UAS™ preservative prevented microbial growth. Under simulated ambient temperature transportation conditions, cfDNA (ΔCt: 0.57 ± 1.58), EV RNA (1.05 ± 0.94), and host cell integrity (0.63 ± 0.73) were successfully maintained. Urinary cfDNA, EV RNA, and host cell integrity from FVU samples were effectively preserved up to 7 days post-collection at RT, and under simulated ambient temperature transportation. By enabling standardized volumetric FVU collection and analyte preservation, the Colli-Pee™ UAS™ 40 mL device demonstrates its viability as a non-invasive FVU self-sampling device for oncology applications, simplifying serial and at-home collection. In addition to the advantages of FVU, Colli-Pee™ collection devices can improve access to testing by allowing for samples to be collected at home and transported at ambient temperature, which can improve the chances of early detection and outcomes for diverse patients in at-risk populations. Citation Format: Kyle MacDonald, Melissa Richer, Thanh Dang, Alejandra Rioscortes, Cameron Wood, Nette Meers, Savannah Colameco, Koen Beyers, Graham Morse, Tara Crawford Parks. Colli-Pee™ UAS™ 40mL: A first-void urine collection device with potential to improve access to cancer screening when paired with an appropriate clinical assay [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr C025.