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Oncuria-Detect is a 10-plex immunoassay that detects\n                      <jats:italic>de novo<\/jats:italic>\n                      bladder cancer by generating a protein biomarker signature from a single voided urine sample. This report details the analysis of our prospective study that compares the diagnostic performance of the multiplex Oncuria-Detect assay to that of the single-analyte (i.e., NMP22) BladderChek\u2122 urine assay and urine cytology for identifying bladder\/urothelial cancer in patients with microscopic hematuria.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>From September 2018 through July 2025, 9 medical facilities in the US and Japan prospectively enrolled 321 participants of whom 292 were deemed eligible. The bladder cancer diagnostic reference standard was cystoscopy with biopsy. Pre-cystoscopy, patients provided a urine sample for analysis by Oncuria-Detect and BladderChek\u2122 (analyzed in a blinded manner) as well as urine cytology.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Bladder cancer was diagnosed in 22 patients (7.5%). The Oncuria-Detect assay had the following performance characteristics 82.0% sensitivity and 97.5% negative predictive value (NPV) compared to BladderChek\u2122 (9.3% sensitivity and 95.4% NPV) and cytology (44.8% sensitivity and 97.2% NPV). Oncuria-Detect displayed favorable sensitivity for identifying early- and late-stage cancer. Oncuria-Detect had a favourable performance in detecting high-grade and MIBC (i.e., aggressive cancers); high-grade sensitivity was 93.5% (95%CI: 0.783\u20131.000) and MIBC sensitivity was 100.0% (95%CI: 1.000\u20131.000) compared to BladderChek\u2122 high-grade sensitivity of 13.8% (95%CI: 0.000\u20130.370) and MIBC sensitivity was 0.0% (95%CI: 0.000\u20130.000) and cytology high-grade sensitivity was 60.1% (95%CI: 0.333\u20130.852) and MIBC sensitivity was 73.9% (95%CI: 0.000\u20131.000).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In this analysis of an international prospective trial, Oncuria-Detect performed favorably in the non-invasive evaluation of bladder cancer presence in patients presenting with microscopic hematuria.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial number<\/jats:title>\n                    <jats:p>Clinicaltrials.gov NCT03193541.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s12967-026-08245-4","type":"journal-article","created":{"date-parts":[[2026,5,9]],"date-time":"2026-05-09T10:44:51Z","timestamp":1778323491000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Detection of bladder cancer in patients with microscopic hematuria using Oncuria-Detect: results of a prospective, multicenter international study"],"prefix":"10.1186","volume":"24","author":[{"given":"Yair","family":"Lotan","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoshi","family":"Anai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Howard","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Greg","family":"Gin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arash","family":"Akhavein","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Makito","family":"Miyake","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Luu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Ahdoot","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward","family":"Messing","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Garry","family":"Peers","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ariel","family":"Moradzadeh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arnold I.","family":"Chin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Menghan","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sunao","family":"Tanaka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sergei","family":"Tikhonekov","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ian","family":"Pagano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yingye","family":"Zheng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhen","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hideki","family":"Furuya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles J.","family":"Rosser","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,5,9]]},"reference":[{"issue":"6","key":"8245_CR1","doi-asserted-by":"publisher","first-page":"628","DOI":"10.1016\/j.euo.2022.10.003","volume":"5","author":"N Lobo","year":"2022","unstructured":"Lobo N, Afferi L, Moschini M, Mostafid H, Porten S, Psutka SP, et al. 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Nara Medical University (IRB# 2696) and Seiwa Medical Hospital (IRB# 206) ethics review board approved the study. Participants gave written informed consent.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Disclaimer"}},{"value":"Dr. Charles Rosser is an officer of Nonagen Bioscience. Yair Lotan has consulted for Photocure, Astra-Zeneca, Merck, Fergene, Nucleix, Ambu, Seattle Genetics, virtuoso surgical, Stimit, Urogen, Vessi medical, CAPs medical, Nonagen, Aura Biosciences, Inc., Convergent Genomics, Pacific Edge, Pfizer, Phinomics Inc, CG oncology, Uroviu, Promis Diagnostics, Valar labs, Uroessentials, NRx Pharmaceuticals, Vesica health, Janssen, Immunity Bio, Trigone pharma, Relmada. All other authors declare that they have no competing interests.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"791"}}