Comparison of the performances of the ADXBLADDER test and urinary cytology in the follow‐up of non‐muscle‐invasive bladder cancer: a blinded prospective multicentric study

Abstract

Objective To compare directly the performance of the ADXBLADDER test with that of cytology in the detection of non‐muscle‐invasive bladder cancer (NMIBC) recurrences. Background ADXBLADDER is a urine test based on the detection of MCM5, a DNA licensing factor expressed in all cells capable of dividing. Expression is usually restricted to the basal stem cell compartment; however, in malignancy, MCM5‐expressing cells can be found throughout the epithelium. Detection of MCM5 in urine sediment can be indicative of the presence of a bladder tumour. Patients and Methods A multicentre prospective, blinded study was carried out from August 2017 and July 2019 at 21 European Union centres, 14 of which collected matching cytology data. Urine was collected from patients prior to cystoscopy. Urine cytology and ADXBLADDER were performed and compared to the diagnosis obtained by cystoscopy. The performance of cytology and ADXBLADDER were then compared. Results The overall performance of ADXBLADDER demonstrated a sensitivity of 51.9%, a specificity of 66.4%, and a negative predictive value (NPV) of 92%. The sensitivity of ADXBLADDER for low‐ and high‐grade recurrences was 44.1% and 58.8%, respectively. By contrast, cytology sensitivity was 16.7%, specificity was 98% and NPV was 90.7%. Cytology sensitivity for both low‐ and high‐grade disease was 17.6%. Conclusions ADXBLADDER detection of both low‐ and high‐grade NMIBC recurrence is superior to that of cytology, with ADXBLADDER able to exclude the presence of high‐grade recurrence in 97.8% of cases compared to 97.1% with cytology. These results show that ADXBLADDER has promise as a more reliable alternative to urine cytology in the follow‐up of NMIBC.

Diagnostic Accuracy of Novel Urinary Biomarker Tests in Non–muscle-invasive Bladder Cancer: A Systematic Review and Network Meta-analysis

“…Twenty-one studies, comprising 7330 patients, were included in the quantitative synthesis. All the studies included in the quantitative synthesis reported on the diagnostic value of UBTs for the detection of recurrence during surveillance: ten studies on Xpert bladder cancer [17][18][19][20][21][22][23][24][25][26], five studies on Bladder EpiCheck [26][27][28][29][30], three on Adxbladder [31][32][33], two on Uromonitor [34,35], and two on Cxbladder Monitor [36,37].…”

Urinary biomarkers to mitigate diagnostic delay in bladder cancer during the COVID-19 era

“…The test has demonstrated an impressive negative predictive value of 92-99% and uses a standard ELISA with a rapid 2-hour turnaround time. However, despite proving superior to urine cytology, the overall performance of ADXBLADDER remains relatively low, with a sensitivity of 51.9% and a specificity of 66.4% 7 .…”

“…In July 2020, the UK National Health Service approved the use of ADXBLADDER to help with the diagnosis and surveillance of bladder cancer 6 . ADXBLADDER detects the presence of MCM5 -a biomarker that is not influenced by infections or inflammation -and is twice as sensitive as urine cytology in the context of surveillance 7 . The test has demonstrated an impressive negative predictive value of 92-99% and uses a standard ELISA with a rapid 2-hour turnaround time.…”

Biomarkers in Bladder Cancer Surveillance

“…The UK National Health Service (NHS) approved the usage of ADxBladder in BC detection. Three prospective studies have been done with only one in the surveillance setting ( 43 ). They reported an overall sensitivity ranging between 45–73%, specificity between 70–73%, and NPV between 74–100% and were superior to cytology ( 47 ).…”