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Background and Objective: Assessment of patients with hematuria (aH) remains a challenge in urological practice, balancing the benefits of diagnosing a potentially underlying bladder cancer (UCa) against the risks of possibly unnecessary diagnostic interventions. This study analyzes the potential of an mRNA-based urine assay, the Xpert ® Bladder Cancer Detection- CE-IVD (Xpert BC-D), in patients with hematuria., Materials and Methods: Overall, 368 patients with newly observed painless hematuria and no history of UCa were included in this observational study. Patients received urological workup, including urethrocystoscopy (WLC), upper tract imaging, urine cytology and Xpert BC-D. Patients with positive WLC were recommended to undergo tumor resection (TUR-B)., Results: After excluding non-assessable cases, 324 patients were considered for analysis (188 males, 136 females; median age: 61 years). Eight of twenty-eight patients with a positive TUR-B had Ta low grade (LG) tumors; the others were diagnosed with high grade (HG) lesions (Ta: 4, CIS: 2, T1:11, > T1:3). The Xpert BC-D was more sensitive than urine cytology (96% vs. 61%) ( p  = 0.002). Increased risk ratios (RR) were observed for gross hematuria, gender, urine cytology, and positive Xpert BC-D (all p  < 0.05). Age and positive Xpert BC-D remained independent predictors of UCa in multivariate analysis. Simulating a triage with WLC restricted to patients with positive Xpert BC-D could have saved 240 (74.1%) assessments at the cost of missing one pTa LG tumor., Conclusions: The results suggest a potential role for Xpert BC-D in preselecting patients with hematuria for either further invasive diagnosis or an alternate diagnostic procedure., Competing Interests: BJSD is consultant, speaker and trialist for Cepheid, Sunnyvale, CA, USA, and Nucleix, Rehovot, Israel/USA and trialist for Concile, Freiburg, Germany, Zetiq/NextAge, Tel Aviv, Israel, and Arquer Diagnostics Ltd, Sunderland, UK. PJG is consultant and trialist for Cepheid, PB, JC, EP, and MB are employees of Cepheid, Sunnyvale, CA, USA BJSD and PJG are members of the Bladder Cancer Editorial Board, (© 2024 – The authors. Published by IOS Press.)

Marker research, and in particular urine bladder cancer marker research throughout the past three decades, devours enormous scientific resources in terms of manpower (not to mention time spent on reviewing and editorial efforts) and financial resources, finally generating large numbers of manuscripts without affecting clinical decision making. This is mirrored by the fact that current guidelines do not recommend marker use due to missing level 1 evidence. Although we recognize the problems and obstacles, the authors of this commentary feel that the time has come to abandon the current procedures and move on to prospective trial designs implementing marker results into clinical decision making. Our thoughts and concerns are summarized in this comment., Competing Interests: PJG, LD, BWGvR, AS and BJSD are Editorial Board members of this journal, but were not involved in the peer-review process nor had access to any information regarding its peer-review. FR, PJG, and OH are trialist for Cepheid Europe, France, Concile, Freiburg, Germany, Nextage Therapeutics Ltd, Tel Aviv, Israel, Arquer Ltd, Newcastle, UK and Nucleix Inc., Rehovot, Israel. AS is consultant to Alere Inc., Waltham, MA, USA and Medical Enterprises EUROPE B.V., Amstelveen, The Netherands and acts as trialist for Cepheid Europe, France, Concile, Freiburg, Germany, Nextage Therapeutics Ltd, Tel Aviv, Israel, Arquer Ltd, Newcastle, UK, GenomeDx Biosciences Corp., San Diego, CA, USA and Nucleix Inc., Rehovot, Israel. BWGvR is scientific advisor for QED Therapeutics –a BridgeBio company, San Francisco, CA, USA. BJSD has sponsored research agreements with and is consultant, speaker and trialist for Cepheid Europe, speaker and trialist for Concile, Freiburg, Germany, and trialist for Nextage Therapeutics Ltd, Tel Aviv, Israel, Arquer Ltd, Newcastle, UK, and Nucleix, Rehovot, Israel. LD has sponsored research agreements with C2i, AstraZeneca, Photocure, Natera and Ferring. LD has an advisory/consulting role at Ferring, and is Chairman of the Board in BioXpedia A/S. HK, MB, BP and NB have no disclosures. No disclosure of stock ownership., (© 2022 – The authors. Published by IOS Press.)