Potential Expansion of HPV Screening With First-Void Urine Self-Sampling

Powering volumetric, non-invasive self-collection of first-void urine Toll-free (North America): 1.866.813.6354 Tel.: +1.613.723.5757 • Fax: +1.613.723.5057 www.dnagenotek.com info@dnagenotek.com DNA Genotek Inc. 3000 - 500 Palladium Drive Ottawa, ON, Canada K2V 1C2 Subsidiary of OraSure Technologies, Inc. Research Use Only Not for diagnostic purposes. *Non-sterile The Colli-Pee™ device* uses a simple self-sampling method to collect a standardized, volumetric urine sample. The Colli-Pee™ device diverts first-void urine, the first 10 mL-20 mL of urine released, into a sample tube, collecting a specific amount of urine and releasing the excess. Once collected, the urine is mixed with a prefilled UCM™ preservative capable of stabilizing DNA from bacteria and viruses, such as human papillomavirus (HPV), for research applications for 7 days at room temperature.1 What is first-void urine? First-void urine is the first fraction of urine produced that exhibits elevated concentrations of specific biomarkers, such as DNA, RNA and proteins from host cells, cell-free DNA and extracellular vesicles.2,3 As a result, first-void urine is a valuable sample type with the potential to support research applications associated with particular diseases, such as nonurogenital oncologic disorders and infectious diseases.4 • N = 280 women • Ages 25-64 years • Self-sampling with Colli-Pee™ UCM™ 20 mL device and dry vaginal self-samples • Self-sampling was well accepted — 48% ± 4% of women indicated a preference for first-void urine over 39% ± 4% who preferred vaginal self-sampling HPV detection in first-void urine The Colli-Pee™ device provides a non-invasive alternative to vaginal swabs and clinician-collected samples with non-inferior sample sensitivity and specificity for HPV detection.5 First-void urine self-sampling has the potential to expand HPV screening through preferred, accessible self-sampling Designed for easy, non-invasive first-void urine collection Standardized volumetric urine collection ISO13485 and GMP-certified manufacturing Self-sampling preference between urine and vaginal samples from the Predictors 5.1, Cocoss and VALHUDES studies. Sample preference between first-void urine and physician-collected cervical samples from the CASUS trial (NCT0453020).9 Compatible with a broad range of automated molecular platforms and assays Room temperature preservation of first-void urine • N = 332 women • Ages 26-70 years • 214 women completed the usability questionnaire from which 210 valid SUS scores were obtained • Home-based self-collection using a Colli-Pee™ UCM™ FV-5010 device the day before colposcopy visit 95% 93% For full collection instructions, visit www.dnagenotek.com Simplified collection Patent (www.dnagenotek.com/legalnotices) Photos used are for illustrative purposes only. Any person depicted in the content is a model. Colli-Pee™ devices are manufactured and distributed by DNA Genotek Inc. Colli-Pee™ is a trademark of DNA Genotek Inc., registered in various jurisdictions. © 2025 DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc., all rights reserved. PD-BR-395 v2/2025-06 Research Use Only Not for diagnostic purposes. *Non-sterile 1 2 3 7 4 6 5 The Colli-Pee™ UCM™ device preserves first-void urine samples spiked with 500,000 cps/mL of HPV-16 plasmid DNA for 8 days1 • Samples were held at 20°C-26°C for 8 days • DNA was extracted at baseline (T0) and endpoint (T8) followed by HPV-specific qPCR • HPV DNA was detected in all preserved first-void urine samples, while unpreserved first-void urine samples experienced significant HPV DNA loss References: 1 MacDonald K, Wood C, Richer M, et al. (2023). Evaluation of UCM® preservative robustness – enabling HPV DNA preservation in first-void urine collected with various Colli-Pee® device formats. DNA Genotek. [White paper]. 2 Augustus E, Casteren K, Sorber L, et al. (2020). The art of obtaining a high yield cell-free DNA from urine. PLOS ONE. 15(4), e0231058. doi: 10.1371/journal pone.0231058 3 Arora A, Cimenci C, et al. (2023). Isolation, characterization and preservation of extracellular vesicles in human first-void urine samples to facilitate self-collection. DNA Genotek. [White paper]. 4 Jordaens S, Arora A, MacDonald K, et al. (2023). UAS™-A Urine Preservative for Oncology Applications. Cancers (Basel). Jun 8;15(12):3119. doi: 10.3390/cancers15123119 5 Giubbi C, Martinelli M, Latsuzbaia A, et al. (2024). Clinical performance of OncoPredict HPV screening assay on self-collected vaginal and urine specimens within the VALHUDES framework. Journal of Medical Virology. 96: e70079. doi: 10.1002/jmv.70079 6 Cadman L, Reuter C, Jitlal M, et al. (2021). Randomized comparison of different vaginal self-sampling devices and urine for human papillomavirus testing-Predictors 5.1. Cancer Epidemiol Biomarkers Prev. (4):661-668. doi: 10.1158/1055-9965.EPI-20-1226 7 Ertik FC, Kampers J, Hülse F, et al. (2021). CoCoss-Trial: Concurrent comparison of self-sampling devices for HPV-detection. International Journal of Environmental Research and Public Health. 18(19), 10388. doi: 10.3390/ijerph181910388 8 Arbyn M, Peeters E, Benoy I, et al. (2018). VALHUDES: A protocol for validation of human papillomavirus assays and collection devices for HPV testing on self-samples and urine samples. Journal of clinical virology. 107, 52–56. doi: 10.1016/j.jcv.2018.08.006 9 Hendrickx JO, Van Keer S, Donders G, et al. (2025). Home-based urinary HPV self-sampling for the detection of cervical cancer precursor lesions: attitudes and preferences from Belgian females participating in the CASUS study. Arch Public Health. 83,32. doi: 10.1186/s13690-024-01490-3 10 Bell M, Baussano I, Rol M, et al. (2024). Optimization and analytical validation of the Allplex HPV28 genotyping assay for use in first-void urine samples. Journal of clinical microbiology. e0140424. Advance online publication. doi: 10.1128/jcm.01404-24 11 Latsuzbaia A, Martinelli M, Giubbi C, et al. (2024). Clinical accuracy of OncoPredict HPV Quantitative Typing (QT) assay on self-samples. Journal of clinical virology. 175, 105737. doi: 10.1016/j.jcv.2024.105737 12 Latsuzbaia A, Van Keer S, Vanden Broeck D, et al. (2023). Clinical accuracy of Alinity m HR HPV Assay on self- versus clinician-taken samples using the VALHUDES protocol. The Journal of molecular diagnostics. 25(12), 957–966. doi: 10.1016/j.jmoldx.2023.09.008 13 Davies JC, Sargent A, Pinggera E, et al. (2024). Urine high-risk human papillomavirus testing as an alternative to routine cervical screening: A comparative diagnostic accuracy study of two urine collection devices using a randomised study design trial. BJOG. 131(11), 1456–1464. doi: 10.1111/1471-0528.17831 14 Van Keer S, Latsuzbaia A, Vanden Broeck D, et al. (2022). Analytical and clinical performance of extended HPV genotyping with BD Onclarity HPV Assay in home-collected first-void urine: A diagnostic test accuracy study. Journal of clinical virology. 155, 105271. doi: 10.1016/j.jcv.2022.105271 Product specifications and attributes • Suitable for collection from all genders • Compatible with common liquid handlers, column-based and mag-bead molecular extraction kits • Optimized for standardized volumetric first-void urine collection • Shelf life: 24 months • Pre-collection storage temperature: 15°C-30°C/59°F-86°F • High-density polypropelyene • Available in volumes of 4 mL, 10 mL and 20 mL In scientific publications, Colli-Pee™ UCM™ first-void urine samples have been shown to be compatible with a broad range of automated molecular platforms and assays, including: • Allplex™ HPV28 HR Detection assay (Seegene, Cat. No. HP10373Z)10 • OncoPredict HPV Quantitative Typing (QT) assay11 • Alinity m HR HPV Assay (Abbott, Cat. No. 09N15-95)12 • Roche cobas® 8800 (Roche, Cat. No. 05412722001)13 • BD Onclarity HPV Assay (BD, Cat. No. 441990)14 To request trial samples or learn more, scan the QR code or visit www.dnagenotek.com/colli-pee