A non-invasive in vitro diagnostic device (IVD) intended to detect and monitor non-muscle invasive
bladder cancer (NMIBC) recurrence, in conjunction with cystoscopy, in previously diagnosed bladder cancer
patients. It provides all the components for a non-invasive detection of a set of hotspot mutations in the
TERTp, FGFR3 and KRAS genes, highly prevalent in bladder cancer, in DNA derived from exfoliated bladder
cells present in urine.
More information at
uromonitor.com
Uromonitor® is a highly sensitive IVD kit, developed and patented (CE/IVD) by researchers
from Ipatimup and U-Monitor. Validated in published series encompassing >1100 samples of patients
followed in national and international health centers, under surveillance NMIBC, the test is based on
the detection of molecular biomarkers present in BC tumor cells found in urine. It is the ideal complement
in the follow-up of patients under surveillance for NMIBC recurrence, allowing to reduce the number of
cystoscopies performed by the patient.
The Uromonitor® kit is composed by three subunits:
1. Uromonitor® - Urine filtration kit (#Urokit1, PUF01/PUF25/PUF50)
Provides the components needed for sample collection. The principle of the procedure relies on the filtration
of urine samples. Using a syringe, urine samples will pass through a filter, with a proprietary conservative, where
exfoliated bladder cells are trapped for subsequent procedures.
2. Uromonitor® - DNA extraction and preparation kit (#Urokit2, PADNP25/PADNP50)
Provides an efficient and fast method for the purification of high-quality cell DNA extracted from cells exfoliated
in urine. Eluted purified DNA is suitable for use with Uromonitor®’s Real-Time PCR procedure.
3. Uromonitor® - Real-Time PCR kit for TERT, FGFR3 and KRAS mutations detection (#Urokit3, PRTPCR25/PRTPCR50)
Provides an efficient method for the detection of mutations in the TERT promoter (-124 and -146), FGFR3 codons 248, 249,
372 and 375, and KRAS codons 12/13 and 61, through a highly sensitive and specific Real-Time PCR method. It includes a mastermix
and 4 independent assays that use allele-specific primers in multiplex reactions to identify the presence of TERTp, FGFR3 and KRAS
mutations in a total of 9 reactions per sample. Each reaction contains primers/probes sets for mutations detection, as well as internal
control (IC), negative and positive DNA controls for sample validation and qualitative analysis
1. Batista, R. et al. Validation of a Novel, Sensitive, and Specific Urine-Based Test for Recurrence Surveillance of Patients With Non-Muscle-Invasive Bladder Cancer in a Comprehensive Multicenter Study. Front Genet 10, (2019).
https://www.frontiersin.org/journals/genetics/articles/10.3389/fgene.2019.01237/full
2. Sieverink, C. A. et al. Clinical Validation of a Urine Test (Uromonitor-V2®) for the Surveillance of Non-Muscle-Invasive Bladder Cancer Patients. Diagnostics 10, (2020).
https://www.mdpi.com/2075-4418/10/10/745
3. Laukhtina, E. et al. Diagnostic Accuracy of Novel Urinary Biomarker Tests in Non-muscle-invasive Bladder Cancer: A Systematic Review and Network Meta-analysis. Eur Urol Oncol 4, 927–942 (2021).
https://www.sciencedirect.com/science/article/pii/S2588931121001838?via%3Dihub
4. Azawi, N. et al. Surveillance of Low-Grade Non-Muscle Invasive Bladder Tumors Using Uromonitor: SOLUSION Trial. Cancers (Basel) 15, (2023).
https://www.mdpi.com/2072-6694/15/8/2341
https://www.mdpi.com/2072-6694/15/8/2341
5. Ramos, P. et al. Uromonitor®: Clinical Validation and Performance Assessment of a Urinary Biomarker for Recurrence Surveillance in Non-Muscle Invasive Bladder Cancer Patients. medRxiv 2023.11.02.23297958 (2024) doi:10.1101/2023.11.02.23297958.
https://www.medrxiv.org/content/10.1101/2023.11.02.23297958v2
6. Kravchuk, A. P. et al. Urine-Based Biomarker Test Uromonitor® in the Detection and Disease Monitoring of Non-Muscle-Invasive Bladder Cancer—A Systematic Review and Meta-Analysis of Diagnostic Test Performance. Cancers vol. 16 Preprint at https://doi.org/10.3390/cancers16040753 (2024).
https://www.mdpi.com/2072-6694/16/4/753