{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T15:31:56Z","timestamp":1793201516968,"version":"4.5.0"},"reference-count":41,"publisher":"Oxford University Press (OUP)","license":[{"start":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T00:00:00Z","timestamp":1787011200000},"content-version":"am","delay-in-days":1,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"US National Institutes of Health (NIH) National Cancer Institute (NCI) research","award":["UH3 CA271377 (C.J.R.), R01 CA277810 (H.F.\/C.J.R.), R01 CA198887 (C.J.R.), and U54 CA274375-01 (H.F.\/C.J.R.)"],"award-info":[{"award-number":["UH3 CA271377 (C.J.R.), R01 CA277810 (H.F.\/C.J.R.), R01 CA198887 (C.J.R.), and U54 CA274375-01 (H.F.\/C.J.R.)"]}],"id":[{"id":"https:\/\/ror.org\/040gcmg81","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Cystoscopy is the standard of care for evaluating patients with gross hematuria, the primary sign of urothelial cancer. The aim was to investigate whether the Oncuria-Detect immunoassay (Nonagen Bioscience Corporation) can improve detection of urothelial cancer while evaluating participants with gross hematuria.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>From September 2016 through July 2025, 9 academic, private practice, and hospital facilities in the United States and Japan prospectively enrolled 450 participants with gross hematuria. Before cystoscopic\/ureteroscopic evaluation, participants provided a urine sample for the Oncuria-Detect assay and the BladderChek Test (Abbott) as well as urine cytology. The diagnostic performance parameters of Oncuria-Detect was compared with BladderChek and urine cytology as an aid in detecting de novo urothelial cancer with cystoscopy\/ureteroscopy and histological evaluation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Urothelial cancer was diagnosed in 97 of 450 participants. The Oncuria-Detect assay was positive in 80 of 97 participants with urothelial cancer, resulting in a sensitivity of 82.6% (95% CI = 74.9% to 89.6%) and a 87.2% negative predictive value (95% CI = 83.8% to 93.0%). BladderChek results were positive in 16 of 97 participants, resulting in a sensitivity of 16.4% (95% CI = 10.0% to 23.5%) and an 80.8% negative predictive value (95% CI = 81.5% to 83.8%). Cytology test results were positive in 35 of 97 participants, with a sensitivity of 35.7% (95% CI = 26.5% to 46.1%) and an 84.6% negative predictive value (95% CI = 84.5% to 88.1%). Oncuria-Detect sensitivity remained relatively high for all grades and all stages. The number needed to evaluate to detect 1 urothelial cancer was 5 for cystoscopy compared with 6 for Oncuria-Detect, 29 for BladderChek, and 13 for cytology.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In this prospective trial, Oncuria-Detect demonstrated statistically significantly higher sensitivity for detecting de novo urothelial cancer than comparator urine tests, supporting its potential as a noninvasive risk-stratification tool for patients presenting with gross hematuria.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>ClinicalTrials.gov<\/jats:title>\n                    <jats:p>NCT03193528<\/jats:p>\n                  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