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Comparative Study
. 2021 Dec;128(6):713-721.
doi: 10.1111/bju.15418. Epub 2021 May 5.

Longitudinal follow-up and performance validation of an mRNA-based urine test (Xpert® Bladder Cancer Monitor ) for surveillance in patients with non-muscle-invasive bladder cancer

Barrett Cowan  1 , Eric Klein  2 , Ken Jansz  3 , Karl Westenfelder  4 , Timothy Bradford  5 , Chad Peterson  6 , Douglas Scherr  7 , Lawrence I Karsh  8 , Blair Egerdie  9 , Alfred Witjes  10 , Andrew Trainer  11 , Richard Harris  12 , Bernard Goldfarb  13 , Stanley Flax  14 , Robert Kroeger  15 , Buffi Boyd  16 , Joseph Liao  17 , Sanjay Patel  18 , Julia Bridge  19 , Victor Reuter  20 , Neil Quigley  21 , Sarah Brown  22 , Suling Zhao  22 , Malini Satya  22 , Michael Bates  22 , Iris M Simon  22 , Scott Campbell  22 , Yair Lotan  23
Affiliations
Comparative Study

Longitudinal follow-up and performance validation of an mRNA-based urine test (Xpert® Bladder Cancer Monitor ) for surveillance in patients with non-muscle-invasive bladder cancer

Barrett Cowan et al. BJU Int. 2021 Dec.

Abstract

Objective: To evaluate the performance of the Xpert Bladder Cancer Monitor (Xpert; Cepheid, Sunnyvale, CA, USA) test as a predictor of tumour recurrence in patients with non-muscle-invasive bladder cancer (NMIBC).

Patients and methods: Patients (n = 429) undergoing surveillance for NMIBC underwent Xpert, cytology, and UroVysion testing. Patients with a positive Xpert and a negative cystoscopy result (positive-negative [PN] group, n = 66) and a control group of double negative patients (negative Xpert and cystoscopy results [NN] group) were followed for 12 months (±90 days).

Results: Histology-confirmed recurrences were detected in 58 patients (13.5%). Xpert had an overall sensitivity of 60.3% and a specificity of 76.5%. The sensitivity for high-grade (HG) cancer was 87% with a negative predictive value (NPV) of 99%. Urine cytology showed an overall sensitivity of 23.2% (47.6% sensitivity for HG tumours) and a specificity of 88.3%. In the PN group, 32% (n = 21) developed a recurrence within 12 months, 11 of which were HG tumours. In the NN control group, 14% (n = 9) developed a recurrence and only two were HG tumours. The hazard ratio for developing recurrence in the PN group was 2.68 for all tumours and 6.84 for HG cancer.

Conclusions: The Xpert test has a high sensitivity for detecting the recurrence of cancer and a high NPV for excluding HG cancer. In addition, the data suggest that patients with a positive Xpert assay in the setting of negative cystoscopy are at high risk for recurrence and need close surveillance.

Keywords: #BladderCancer; #blcsm; #uroonc; anticipatory positive; liquid biopsy; molecular diagnostic; non-muscle-invasive bladder cancer; surveillance.

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Conflict of interest statement

Dr Lotan reports personal fees from fergene, Ferring Research, Merck, C2I genomics, photocure, Astra Zeneca, AbbVie, Cleveland Diagnostics, BMS, Nucleix, Ambu, Seattle Genetics and Hitachi, outside the submitted work and grants from Abbott, Cepheid, Pacific Edge, and GenomeDx Biosciences, Inc., outside the submitted work. Dr Bridge reports grants from Cepheid, during the conduct of the study, and other from Merck and Bayer, outside the submitted work. Dr Quigley works for Genuity. Geneuity received payment from Cepheid for performing testing on this study. Ms Brown reports personal fees from Cepheid, during the conduct of the study, personal fees from Cepheid, outside the submitted work, and is an employee of a company who sponsored the study. Mrs Zhao reports other from Cepheid (study sponsor and funding source), outside the submitted work. Ms Satya reports other from Cepheid, outside the submitted work. Dr Bates reports personal fees from Cepheid and Danaher, during the conduct of the study, personal fees from Cepheid and Danaher, outside the submitted work. Dr Campbell reports other from Cepheid (study sponsor and funding source), outside the submitted work. All other authors have nothing to declare.

Figures

Fig. 1
Fig. 1
Subject accountability in the baseline and longitudinal Xpert Monitor Study.
Fig. 2
Fig. 2
Kaplan‐‐Meier curves for recurrence in patients in the negative Xpert and negative cystoscopy (NN) group and those in the positive Xpert and a negative cystoscopy (PN) group for recurrences of (A) all tumours, (B) only high‐grade tumours and (C) only low‐grade tumours.
See this image and copyright information in PMC

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