What is Uromonitor
UROMONITOR is a new urine-based test with 100% Sensitivity, independently of tumor stage and grade, and 97.3% Specificity biomarker for Non-Muscle invasive bladder cancer.
It can be used for detecting the tumor in patients under surveillance or suspected of bladder cancer (e.g. Hematuria), ancillary to cystoscopy and urine cytology. Uromonitor® is CE certified.
Health Issues
Bladder Cancer
- About 330.000 people are diagnosed each year
- About 145.000 patients die each year
- Up to 70% of cases cancer comes back, even after adequate treatment
- Tumor recurrence is currently detected by endoscopic examination of the bladder (cystoscopy)
- Cystoscopy findings are sometimes equivocal and ancillary urine cytology has particularly low sensitivity in low grade tumors (16%)
Consequences:
- About 1 million patients are permanently under surveillance
- Regular surveillance to detect recurrence is mandatory (3 months to yearly intervals)
- Repeated invasive endoscopic procedures bring discomfort and are painful to patients
- Bladder cancer has the most expensive follow-up of all cancer types (2.6 to 3.7 Billion USD per year; 169,000 USD per patient)
- Urologists need more sensitive ancillary methods to provide accurate assessment
Solution
A Reliable and Convenient NON-INVASIVE solution, based on a new patented urine test for FGFR3 and Tert promoter mutations, which have shown to be highly sensitive and SPECIFIC in detecting recurrence of bladder cancer. This test can be performed adjunct to cystoscopy , reduce the associated discomfort for patients and improve their quality of life, besides reducing the economic impact of extensive surveillance. Studies have shown Uromonitor lowers medical costs by 50%.
Test Features
Non-invasive
Based on a simple urine analysis avoiding the recurrent cystoscopies
Ultrasensitive
Capable of detecting from 7 abnormal molecules per 1000 normal
Proprietary
The test is covered by an International-scope PCT Patent Application protecting the method, compositions and the probes used.
Validated in Clinical Studies
Studies in over 400 samples from eligible patients under surveillance for bladder cancer, the biomarkers have demonstrated to be highly sensitive and specific (> 97,3% sensitivity and 100% specificity)
Easy, with no specific equipment needed
A urine filtration kit is made available free of charge and filters are sent at room temperature to Uromonitor Lab where the test is run and results are delivered in 5 working days.
Uromonitor Testing Wokflow
Research
The test was developed by researchers from IPATIMUP, a renowned cancer research center (www.ipatimup.pt) at Oporto, Portugal.
Uromonitor’s team of researchers are experts in biomarkers in the cancer biology and molecular genetics field.
Clinical Studies
The Uromonitor test was validated with clinical samples from bladder cancer patients followed-up at the Portuguese Institute of Oncology.
A showcase study involving the leading expert in the field Dr Fred Witjes is now undergoing at an International reference center in Urology (Radboud University Nijmegen Medical Centre - The Netherlands).
Team
The test is performed by highly qualified personal that has been involved in performing the Uromonitor test throughout the development and validation phases, thus insuring the accumulated experience to achieve the best results.
All aspects of customer relationships are handled by an expedite team of logistics and customer support experts.
Lab Facilities
State-of the art Uromonitor Lab facilities at Ipatimup and i3S are used to run the test, in keeping with all laboratory quality standards.
Uromonitor benefits
Patients or Individuals at risk
Patients undergoing surveillance of bladder cancer, who express the need for less invasive detection methods, Uromonitor offers a totally non-invasive test that is performed in a convenient urine sample.
Urologists
For the Urologists who need more accurate ancillary tests to monitor bladder cancer recurrence, Uromonitor provides an in vitro diagnosis test with a close to 100% specificity for bladder cancer and an evenly high sensitivity that is irrespective of tumor grade (unlike cytology).