The goal of the risk stratification was to provide a likelihood of cancer in low, intermediate, and high-risk patients as well as personalize the intensity of evaluation based on baseline risk for disease. Low-risk patients were offered repeat urinalysis (UA) within 6 months and only received evaluation if there was persistent hematuria. Intermediate risk patients were recommended cystoscopy and renal ultrasound. However, “in appropriately counseled intermediate-risk patients who want to avoid cystoscopy and accept the risk of forgoing direct visual inspection of the bladder urothelium, clinicians may offer urine cytology or validated urine-based tumor markers.” High-risk patients were recommended cystoscopy and cross-sectional imaging. Since the current referral rate for MH is very low nationwide, the hope is that these guidelines would improve compliance with recommendations, with resultant improved rate of appropriate evaluations.
One of the major modifications in the new guidelines was the inclusion of urine-based tumor markers as potential tools to evaluate patients with intermediate-risk bladder cancer. The guidelines panel focused on a high negative predictive value (NPV) for these markers since patients with negative markers would forgo immediate cystoscopy. To be included as a potential marker, the NPV for the marker had to be studied in over 100 patients with either a purely MH population or at least 25% of the cohort had to have MH.
With this background in mind, the goal of the present study was to evaluate the performance of Oncuria-Detect in a prospective cohort of patients with MH. Oncuria®-Detect (Nonagen Bioscience Corp, Los Angeles, CA) is a 10-plex immunoassay that tests urine samples for the presence of 10 proteins (A1AT, APOE, ANG, CA9, IL8, MMP9, MMP10, PAI1, SDC1, and VEGF) to generate a bladder cancer risk score based on the urinary protein profile. This study was carried out at 9 medical facilities in the US and Japan and prospectively enrolled 321 participants, of whom 292 were deemed eligible. Patients had a complete evaluation, including cystoscopy and imaging with biopsy as indicated. Furthermore, BladderChek™, which is an FDA-approved assay for NMP22, was analyzed in a blinded manner, and cytology was also performed. Similar to prior studies, bladder cancer was found in 7.5% of the entire cohort. The Oncuria-Detect assay had an overall sensitivity of 82.0% sensitivity and NPV of 97.5%. This was superior to BladderChek™, which had a sensitivity of 9.3% and an NPV of 95.4%. Oncuria-Detect had a high sensitivity for both high-grade (93.5%) and muscle-invasive bladder cancer (100%).
One of the main findings of this study is that Oncuria-Detect performs at a level that is consistent with guideline-recommended levels for use in intermediate risk MH patients. The NPV was 97.5%, which is similar to other urine markers that are included in the current AUA MH guidelines. For patients with intermediate risk disease who want to avoid cystoscopy, such a urine marker could offer a potential alternative similar to other urine markers.
Written by: Yair Lotan,1 Charles J. Rosser2
- Department of Urology, University of Texas Southwestern, Dallas, TX, USA.
- Department of Urology, Cedars-Sinai Medical Center, Los Angeles, CA
- Barocas DA, Lotan Y, Matulewicz RS, Raman JD, Westerman ME, Kirkby E, Pak LJ, Souter L. Updates to Microhematuria: AUA/SUFU Guideline (2025). J Urol. 2025 May;213(5):547-557. doi: 10.1097/JU.0000000000004490. Epub 2025 Feb 27.PMID: 40013563
- Lotan Y, Anai S, Kim H, Gin G, Akhavein A, Miyake M, Luu M, Ahdoot M, Messing E, Peers G, Chen A, Moradzadeh A, Chin AI, Liu M, Tanaka S, Tikhonekov S, Pagano I, Zheng Y, Zhang Z, Furuya H, Rosser CJ. Detection of bladder cancer in patients with microscopic hematuria using Oncuria-Detect: results of a prospective, multicenter international study. J Transl Med. 2026 May 9. doi: 10.1186/s12967-026-08245-4. Online ahead of print.PMID: 42106837Lotan Y, Anai S, Kim H, Gin G, Akhavein A, Miyake M, Luu M, Ahdoot M, Messing E, Peers G, Chen A, Moradzadeh A, Chin AI, Liu M, Tanaka S, Tikhonekov S, Pagano I, Zheng Y, Zhang Z, Furuya H, Rosser CJ. Detection of bladder cancer in patients with microscopic hematuria using Oncuria-Detect: results of a prospective, multicenter international study. J Transl Med. 2026 May 9. doi: 10.1186/s12967-026-08245-4. Online ahead of print.PMID: 42106837
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AUA 2026: Detection of Bladder Cancer in Patients with Microscopic Hematuria using Oncuria-Detect, Interim Analysis of an International Prospective Study