Uromonitor® as a Novel Sensitive and Specific Urine-based Test for Recurrence Surveillance of Patients with Non-muscle Invasive Bladder Cancer
Currently, the gold standard procedure for detection and follow-up of NMIBC is based on the association of cystoscopy and urine cytology. As cystoscopy is a very invasive approach, over the years, many different non-invasive (both in serum and urine samples) assays have been developed in order to search genetic and protein alterations related to the development, progression and recurrence of bladder cancer. TERT promoter mutations and FGFR3 hotspot mutations are the most frequent somatic alterations in bladder cancer and constitute the most reliable biomarkers for bladder cancer.
Based on these findings, an ultra-sensitive assay called Uromonitor® was developed that corresponds to a urine-based assay capable of detecting trace amounts of the two most common alterations in NMIBC, TERT promoter and FGFR3 mutation, in urine samples. The Uromonitor® test was performed in a cohort of 72 patients, firstly diagnosed with bladder cancer and under surveillance for NMIBC, to access its sensitivity and specificity in the detection of NMIBC recurrence. Uromonitor® was shown to be highly sensitive and specific in detecting recurrence of bladder cancer in patients under surveillance of non-muscle invasive bladder cancer.
Authors: Cristina Sampaio1,2,4, Rui Batista1,2,4, Pedro Peralta7 , Paulo Conceição7 , Amílcar Sismeiro7 , Hugo Prazeres1,2,4,5, João Vinagre1,2,3,4, Paula Soares1,2,3,4 .
Author Affiliation:
1. Institute for Research and Innovation in Health
2. i3S Institute of Molecular Pathology and Immunology of the University of Porto (IPATIMUP)
3. Department of Pathology, Medical Faculty, University of Porto
4. U-Monitor
5. Laboratory of Molecular Pathology
6. Anatomic Pathology Service and 7 Urology Service of the Portuguese Institute of Oncology.
Uromonitor® as a novel sensitive and specific urine-based test for recurrence surveillance of patients with non-muscle invasive bladder cancer. Cristina Sampaio, Rui Batista, Pedro Peralta, Paulo Conceicao, Amilcar Sismeiro, HugoPrazeres, Joao Vinagre, Paula Soares bioRxiv 410738; doi: https://doi.org/10.1101/410738