About

Uromonitor®_V2
Urine mutation test

Finally, a convenient way for patients and urologysts to manage the burden of bladder cancer survaillance.

A Reliable and Non-invasive Urine test, based on a Patented method that assesses a specific set of FGFR3/TERTp biomarker hotspot mutations which are 100% Sensitivity and 97.3% Specificity for detecting bladder cancer (BC), independently of tumor stage and of grade, Outperforming cytology in detecting recurrence of non-muscle invasive BC and allowing a reduction in cystoscopies, more convenient for the patients and at Lower Cost.

Test was validated in a Multicentric study and at Reference Urology Center: Radboud UMC (Netherlands)

Test is CE marked for EU and submitted to FDA 510k procedure and can be run as a Service or as and IVD with Standard Real-Time PCR equipment

Health Problem

Bladder Cancer

Second most frequent malignancy of the urinary tract;
Over 500 000 cases under follow-up;
50-70% recurrence rate.

Consequences

Intensive follow-up is required for a period of 5 years.
Cystoscopy is the conventional method:

Year 1 / Year 2 Year 3 / Year 4 Year 5

4 cystocopies/year 2 cystocopies/year 1 cystocopies/year
Discomfort for patients;
Ancillary methods such as Urine Cytology has low sensitivity, particularly in low grade cases (~16% sensitivity);
Costly for the healthcare: Current bladder cancer surveillance cost: $2.6-3.7B/year (the Most expensive follow- up per-patient from diagnosis to death (169,000$ /patient).

Year 1 / Year 2	Year 3 / Year 4	Year 5
4 cystocopies/year	2 cystocopies/year	1 cystocopies/year

Product Features

Ultrasensitive

Detects biomarker even highly diluted . Detects as low as 7 aberrant molecules per 1.000 normal molecules.

Non-invasive

Urine samples, collected through a filter that can be sent to a central Lab at room temperature.

Proprietary

Patented by an International-scope PCT Application.

National Offices validation in US; CN; BR; EU; CN; IN; RS; AU; JP.

Clinically validated

Tested in clinical setting	Follow-up	Diagnostics / Hematuria
Highly Sensitive	(100%)	(100%)
Highly Specific	(97.3%)	(83,3%)

Scientific Publications

Prospective validation of urine based FGFR screening by Uromonitor within the real-world clinicopathological register trial BRIDGister

The objective of the present study was to prospectively evaluate FGFR mutation detetion in matched urine and tissue samples from patients suspicious of bladder cancer and undergoing first TURB within the framework of the BRIDGister RealWorld Experience trial. Results: The pilote cohort of the BRIDGister trial consisted of 47 patients (median age: 77, male 65% vs… Read more »

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

The Uromonitor test was recently validated by the scientific community in a international recognized peer-reviewed journal (Frontiers in Genetics) in a multicentric study comprising more than 300 human samples. Uromonitor presented high sensitivity (74%) and specificity (93%) in the detection of recurrence in patients under Follow-up for Non-Muscle Invasive Bladder Cancer. The details of… Read more »

BIOMARKERS FOR BLADDER CANCER DIAGNOSIS AND SURVEILLANCE: A COMPREHENSIVE REVIEW

Uromonitor test was recognized and considered by the scientific community as an excellent alternative for the non-invasive follow-up of patients previously diagnosed with Non-Muscle Invasive Bladder Cancer in a scientific article that was issue cover in an recognized international journal (Diagnostics). Bladder cancer (BC) ranks as the sixth most prevalent cancer in the world, with… Read more »

TERT PROMOTER MUTATION AS A POTENTIAL PREDICTIVE BIOMARKER IN BCG-TREATED BLADDER CANCER PATIENTS

Recently, investigators described in a scientific publications in a recognized international journal (International Journal of Molecular Sciences), the future possibility of the use of an genetic alterations in TERT gene, included in the Uromonitor test, to be used as a therapy response predictive biomarker in BCG treatment. The details of this study can be found… Read more »