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. 2021 Feb;4(1):93-101.
doi: 10.1016/j.euo.2020.09.001. Epub 2020 Sep 28.

Validation of an mRNA-based Urine Test for the Detection of Bladder Cancer in Patients with Haematuria

Franciscus Johannes P van Valenberg  1 , Andrew M Hiar  2 , Ellen Wallace  2 , Julia A Bridge  3 , Donna J Mayne  4 , Safedin Beqaj  5 , Wade J Sexton  6 , Yair Lotan  7 , Alon Z Weizer  8 , Godfrey K Jansz  9 , Arnulf Stenzl  10 , John F Danella  11 , Kevin J Cline  12 , Michael B Williams  13 , Scott Montgomery  14 , Richard D David  15 , Richard Harris  16 , Eric W Klein  17 , Timothy J Bradford  18 , Fred N Wolk  19 , Karl R Westenfelder  20 , Andrew F Trainer  21 , Timothy A Richardson  22 , Russell B Egerdie  23 , Bernard Goldfarb  24 , Joseph A Zadra  25 , Xixi Lu  2 , Iris M Simon  2 , Scott A Campbell  2 , Michael P Bates  2 , Russell G Higuchi  2 , J Alfred Witjes  26
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Free article

Validation of an mRNA-based Urine Test for the Detection of Bladder Cancer in Patients with Haematuria

Franciscus Johannes P van Valenberg et al. Eur Urol Oncol. 2021 Feb.
Free article

Abstract

Background: In patients with haematuria, a fast, noninvasive test with high sensitivity (SN) and negative predictive value (NPV), which is able to detect or exclude bladder cancer (BC), is needed. A newly developed urine assay, Xpert Bladder Cancer Detection (Xpert), measures five mRNA targets (ABL1, CRH, IGF2, UPK1B, and ANXA10) that are frequently overexpressed in BC.

Objective: To validate the performance of Xpert in patients with haematuria.

Design, setting, and participants: Voided precystoscopy urine specimens were prospectively collected at 22 sites from patients without prior BC undergoing cystoscopy for haematuria. Xpert, cytology, and UroVysion procedures were performed. Technical validation was performed and specificity (SP) was determined in patients without BC.

Outcome measurements and statistical analysis: Test characteristics were calculated based on cystoscopy and histology results, and compared between Xpert, cytology, and UroVysion.

Results and limitations: We included 828 patients (mean age 64.5 yr, 467 males, 401 never smoked). Xpert had an SN of 78% (95% confidence interval [CI]: 66-87) overall and 90% (95% CI: 76-96) for high-grade (HG) tumours. The NPV was 98% (95% CI: 97-99) overall. The SP was 84% (95% CI: 81-86). In patients with microhaematuria, only one HG patient was missed (NPV 99%). Xpert had higher SN and NPV than cytology and UroVysion. Cytology had the highest SP (97%). In a separate SP study, Xpert had an SP of 89% in patients with benign prostate hypertrophy and 92% in prostate cancer patients.

Conclusions: Xpert is an easy-to-use, noninvasive test with improved SN and NPV compared with cytology and UroVysion, representing a promising tool for identifying haematuric patients with a low likelihood of BC who might not need to undergo cystoscopy.

Patient summary: Xpert is an easy-to-perform urine test with good performance compared with standard urine tests. It should help identify (micro)haematuria patients with a very low likelihood to have bladder cancer.

Keywords: Bladder cancer; Cystoscopy; Diagnostic test; Non–muscle-invasive bladder cancer; Sensitivity; Specificity; Urine test; mRNA.

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