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

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.

To validate the performance of Xpert in patients with haematuria.

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.

Test characteristics were calculated based on cystoscopy and histology results, and compared between Xpert, cytology, and UroVysion.

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.

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.

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.

European urology oncology. 2020 Sep 28 [Epub ahead of print]

Franciscus Johannes P van Valenberg, Andrew M Hiar, Ellen Wallace, Julia A Bridge, Donna J Mayne, Safedin Beqaj, Wade J Sexton, Yair Lotan, Alon Z Weizer, Godfrey K Jansz, Arnulf Stenzl, John F Danella, Kevin J Cline, Michael B Williams, Scott Montgomery, Richard D David, Richard Harris, Eric W Klein, Timothy J Bradford, Fred N Wolk, Karl R Westenfelder, Andrew F Trainer, Timothy A Richardson, Russell B Egerdie, Bernard Goldfarb, Joseph A Zadra, Xixi Lu, Iris M Simon, Scott A Campbell, Michael P Bates, Russell G Higuchi, J Alfred Witjes

Department of Urology, Radboudumc, Nijmegen, The Netherlands. Electronic address: ., Cepheid, Sunnyvale, CA, USA., University of Nebraska Medical Center, Omaha, NE, USA., Sacred Heart Hospital, Pensacola, FL, USA., Pathology, Inc, Torrance, CA, USA., Department of Genitourinary Oncology, Moffitt Cancer Center, Tampa, FL, USA., UT Southwestern Medical Center, Dallas, TX, USA., University of Michigan Hospital, Ann Arbor, MI, USA., Urology Office of G. Kenneth Janz, Burlington, Ontario, Canada., Department of Urology, University Medical Clinic of Tübingen, Tübingen, Germany., Geisinger Health System, Danville, PA, USA., Regional Urology, Shreveport, LA, USA., Urology of Virginia, Virginia Beach, VA, USA., Kansas City Urology Care, Overland Park, KS, USA., Skyline Urology, Torrance, CA, USA., UroPartners, Melrose Park, IL, USA., Idaho Urologic Institute, Meridian, ID, USA., Virginia Urology, Richmond, VA, USA., Skyline Urology, Sherman Oaks, CA, USA., Five Valleys Urology, Missoula, MT, USA., Adult, Pediatric Urology, Omaha, NE, USA., Wichita Urology Group, Wichita, KS, USA., Urology Associates/Urologic Medical Research, Kitchener, Ontario, Canada., North Bay, Ontario, Canada., Barrie, Ontario, Canada., Department of Urology, Radboudumc, Nijmegen, The Netherlands.

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