Comparison of the performance of ADXBLADDER test and urinary Cytology in the follow up of Non-Muscle Invasive Bladder Cancer: a blinded prospective multicentric study.

The objective of the study was to directly compare the performance of ADXBLADDER and cytology in the detection of NMIBC recurrences.

ADXBLADDER is a urine test based upon 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.

A multicentre prospective, blinded study was carried out from August 2017 and July 2019 at 21 EU 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.

Overall performance of ADXBLADDER demonstrated a sensitivity of 51.9%, specificity 66.4%, and NPV 92%. Sensitivity of ADXBLADDER for LG and HG recurrences was 44.1% and 58.8% respectively. In contrast cytology sensitivity was 16.7%, specificity 98% and NPV of 90.7%. Cytology sensitivity for both LG and HG was 17.6%.

ADXBLADDER detection of both LG and HG NMIBC recurrence is superior to that of cytology, with ADXBLADDER able to exclude the presence of HG recurrence in 97.8% of cases compared to cytology's 97.1%. These results reveal a promising case for ADXBLADDER as a more reliable alternative to urine cytology in the follow up of NMIBC.

BJU international. 2020 Aug 03 [Epub ahead of print]

P Gontero, E Montanari, M Roupret, F Longo, J Stockley, A Kennedy, O Rodriguez, Src McCracken, T Dudderidge, C Sieverink, F Vanié, M Allasia, J A Witjes, R Sylvester, M Colombel, J Palou

Ospedale Molinette, Dept. of Urology, Turin, Italy., Universita' Policlinico Milano, Dept. of Urology, Milan, Italy., Sorbonne Université, GRC n°5, ONCOTYPE-URO, AP-HP, Urology department, Hôpital Pitié-Salpêtrière, F-75013, PARIS, France., Arquer Diagnostics, R&D, Sunderland, United Kingdom., Fundacio Puigvert, Dept of Urology, Barcelona, Spain., Sunderland Royal Hospital, Sunderland, UK., University Hospital Southampton, Southampton, UK., Radboud University Medical Centre, Dept. of Urology, Nijmegen, The Netherlands., EAU Non-muscle Invasive Guidelines Panel, EAU Guidelines Office, Brussels, Belgium., Hôpital Edouard Herriot, Dept. of Urology, Lyon, France.