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. 2024 Mar 12;10(1):25-33.
doi: 10.3233/BLC-230089. eCollection 2024.

Potential of an mRNA-Based Urine Assay (Xpert® Bladder Cancer Detection1) in Hematuria Patients - Results from a Cohort Study

Claudia Schmitz-Dräger  1 , Peter J Goebell  2 , Ellen Paxinos  3 , Ekkehardt Bismarck  1 , Jack Chen  4 , Priya Balakrishnan  4 , Michael Bates  3 , Thomas Ebert  1 , Bernd J Schmitz-Dräger  1   2 , Natalya Benderska-Söder  1
Affiliations

Potential of an mRNA-Based Urine Assay (Xpert® Bladder Cancer Detection1) in Hematuria Patients - Results from a Cohort Study

Claudia Schmitz-Dräger et al. Bladder Cancer. .

Abstract

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.

Keywords: Hematuria; bladder cancer; gross hematuria; mRNA; microhematuria; urine markers.

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Conflict of interest statement

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

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