TY - JOUR
T1 - A Novel, non-invasive Test Enabling Bladder Cancer Detection in Urine Sediment of Patients Presenting with Haematuria
T2 - A Prospective Multicentre Performance Evaluation of ADXBLADDER
AU - Dudderidge, Tim
AU - Stockley, Jacqui
AU - Nabi, Ghulam
AU - Mom, Jaswant
AU - Umez-Eronini, N.
AU - Hrouda, D.
AU - Cresswell, Jo
AU - McCracken, Stuart Robert Crozier
N1 - Funding Information:
Funding/Support and role of the sponsor : This study was supported by Arquer Diagnostics Ltd .
Publisher Copyright:
© 2019 The Authors
Copyright:
Copyright 2019 Elsevier B.V., All rights reserved.
PY - 2020/2
Y1 - 2020/2
N2 - Bladder cancer is the sixth most commonly diagnosed cancer in the European Union. Here, we evaluate the performance of a novel, commercially available enzyme-linked immunosorbent assay utilising MCM5 antibodies (ADXBLADDER; Arquer Diagnostics Ltd, Sunderland, UK) for the detection of bladder cancer, in a blinded, prospective study of 856 patients, across seven centres, presenting with haematuria. The results were compared with the patients’ clinical data and final diagnosis as defined by the results of the imaging and cystoscopy, with a prevalence of bladder cancer of 8.6%. ADXBLADDER detected bladder tumours in 54/74 cancers, giving overall sensitivity of 73.0% and an overall negative predictive value (NPV) of 96.4%. Sensitivity and NPV of ADXBLADDER were highest in muscle-invasive bladder cancer, both at 100%, and on analysis of non-pTa (pT1 and above) tumours, the sensitivity for detection was 97% with an NPV of 99.8%. A subset of 173 patients had matching cytology data; of these patients, 18 were positive for bladder cancer. ADXBLADDER detected 16/18 of these cancers, whilst cytology was positive in only four of 18, providing evidence that ADXBLADDER may be a more sensitive test for bladder cancer than standard urine cytology. Patient summary: We conducted a large clinical study of a novel, simple urine test (ADXBLADDER), which measures a protein (MCM5) in urine and can be used to detect bladder cancer in patients. We recruited 856 patients and demonstrated that the new urine test can detect bladder cancer with a high degree of accuracy, performing better than the most commonly used urine test—urine cytology. In conclusion, this novel ADXBLADDER urine test can be used to help detect bladder cancers and it can replace the current, standard urine test. The ADXBLADDER test measures the novel biomarker MCM5. Outperforming cytology, and achieving one of the highest sensitivities and negative predictive values of any urine test for bladder cancer diagnosis, it has the potential to improve the bladder cancer diagnostic pathway.
AB - Bladder cancer is the sixth most commonly diagnosed cancer in the European Union. Here, we evaluate the performance of a novel, commercially available enzyme-linked immunosorbent assay utilising MCM5 antibodies (ADXBLADDER; Arquer Diagnostics Ltd, Sunderland, UK) for the detection of bladder cancer, in a blinded, prospective study of 856 patients, across seven centres, presenting with haematuria. The results were compared with the patients’ clinical data and final diagnosis as defined by the results of the imaging and cystoscopy, with a prevalence of bladder cancer of 8.6%. ADXBLADDER detected bladder tumours in 54/74 cancers, giving overall sensitivity of 73.0% and an overall negative predictive value (NPV) of 96.4%. Sensitivity and NPV of ADXBLADDER were highest in muscle-invasive bladder cancer, both at 100%, and on analysis of non-pTa (pT1 and above) tumours, the sensitivity for detection was 97% with an NPV of 99.8%. A subset of 173 patients had matching cytology data; of these patients, 18 were positive for bladder cancer. ADXBLADDER detected 16/18 of these cancers, whilst cytology was positive in only four of 18, providing evidence that ADXBLADDER may be a more sensitive test for bladder cancer than standard urine cytology. Patient summary: We conducted a large clinical study of a novel, simple urine test (ADXBLADDER), which measures a protein (MCM5) in urine and can be used to detect bladder cancer in patients. We recruited 856 patients and demonstrated that the new urine test can detect bladder cancer with a high degree of accuracy, performing better than the most commonly used urine test—urine cytology. In conclusion, this novel ADXBLADDER urine test can be used to help detect bladder cancers and it can replace the current, standard urine test. The ADXBLADDER test measures the novel biomarker MCM5. Outperforming cytology, and achieving one of the highest sensitivities and negative predictive values of any urine test for bladder cancer diagnosis, it has the potential to improve the bladder cancer diagnostic pathway.
KW - Bladder cancer
KW - Diagnosis
KW - Enzyme-linked immunosorbent assay
KW - Urine test
UR - http://www.scopus.com/inward/record.url?scp=85068797844&partnerID=8YFLogxK
U2 - 10.1016/j.euo.2019.06.006
DO - 10.1016/j.euo.2019.06.006
M3 - Article
C2 - 31307961
AN - SCOPUS:85068797844
SN - 2588-9311
VL - 3
SP - 42
EP - 46
JO - European Urology Oncology
JF - European Urology Oncology
IS - 1
ER -