Detects biomarker even highly diluted . Detects as low as 7 aberrant molecules per 1.000 normal molecules.
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
- Second most frequent malignancy of the urinary tract;
- Over 500 000 cases under follow-up;
- 50-70% recurrence rate.
- 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).
Urine samples, collected through a filter that can be sent to a central Lab at room temperature.
Patented by an International-scope PCT Application.
National Offices validation in US; CN; BR; EU; CN; IN; RS; AU; JP.
Tested in clinical setting
Diagnostics / Hematuria
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 »
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 »
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 »
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 »
Table 3. Comparing Uromonitor-V2 Test Characteristics with urine cytology.
Figure 1. comparing ROC curves of urine cytology (red) with Uromonitor-V2 (black) for patients with a historic of NMIBC.
Table 2. Test performances in enrolled patients (n = 97), per subgroup.
Uromonitor Performance (Histology Confirmed Recurrences)
In Vitro Diagnostics Testing Kits are available too, for Labs to run the test locally
Test is CE marked and recommended in European Urology Guidelines
- South Africa
(Distributors in 15 countries)
- Product development manager
- Senior Cancer Researcher
- Research Project Management
- PhD in Human Biology
- PhD in Biomedicine
- Laboratory manager
- R&D Projects manager
- BsC in Biology
- Laboratory Technician
- Support to Service providing
- PhD in Biomedicine, MBA
- Training in Medical Device Certification
- Business Administrator
- Business Development Department
- Business Development
- Marketing Expert
- Sales Department
UROMONITOR ranks Nr. 1 in Sensitivity/Specificity versus other tests