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

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

Consequences

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).

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

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

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 »

Urologist Bladder Cancer UROMONITOR
BIOMARKERS FOR BLADDER CANCER DIAGNOSIS AND SURVEILLANCE: A COMPREHENSIVE REVIEW

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

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 »

Test Performance

NJIMEGEN STUDY (PI: Fred Witjes)

Table 3. Comparing Uromonitor-V2 Test Characteristics with urine cytology.

NJIMEGEN STUDY (PI: Fred Witjes)

Figure 1. comparing ROC curves of urine cytology (red) with Uromonitor-V2 (black) for patients with a historic of NMIBC.

NJIMEGEN STUDY (PI: Fred Witjes)

Table 2. Test performances in enrolled patients (n = 97), per subgroup.

Uromonitor Bladder Cancer test performance

Uromonitor Performance (Histology Confirmed Recurrences)

Uromonitor Bladder Cancer test performance

How the test can be performed

Uromonitor is currently available as a Service at a Central Lab which you can access through to the following steps:

Bladder cancer - How the test can be performed

In Vitro Diagnostics Testing Kits are available too, for Labs to run the test locally

Market Feedback

  • Portugal
  • Spain
  • Netherlands
  • Denmark
  • Germany
  • Jordain
  • Brasil
  • South Africa
Market Feedback

(Distributors in 15 countries)

UROMONITOR Team

Tânia Moura

Tânia Moura

Senior account manager - Europe

João Brás

João Brás

  • Product development manager
Paula Soares

Paula Soares

Scientific Advisor

  • Senior Cancer Researcher
  • Research Project Management
  • PhD in Human Biology
João Vinagre

João Vinagre

Research Projects Manager

  • PhD in Biomedicine
  • Laboratory manager
  • R&D Projects manager
Carolina Dias

Carolina Dias

Laboratory Department

  • BsC in Biology
  • Laboratory Technician
  • Support to Service providing
Hugo Prazeres

Hugo Prazeres

Technical Support & Regulatory

  • PhD in Biomedicine, MBA
  • Training in Medical Device Certification

David Caldeira

Senior Manager

  • Business Administrator
  • Business Development Department
André Caldeira

André Caldeira

Manager

  • Business Development
  • Marketing Expert
Fernando Vieira

Fernando Vieira

Operations Manager

  • Sales Department

UROMONITOR ranks Nr. 1 in Sensitivity/Specificity versus other tests

UROMONITOR ranks Nr. 1 in Sensitivity/Specificity versus other tests

UROMONITOR ranks