Diagnosis and follow-up of bladder cancer
Non-invasive test based on artificial intelligence and image analysis for the diagnosis and follow-up of bladder cancer.
Sensitive and reproducible, this test, performed prior to cystoscopy, enables the personalization and adaptation of patient management.
Benefits
Results are sent within 8 days, allowing guidance and personalization of patient management.
Trained on urine cytology samples correlated with endoscopic and histological results
Performed from a simple spontaneous urine sample
Performance improvement through data accumulation
Clinical
VisioCyt® Bladder was clinically validated in the prospective multicenter clinical trial VISIOCYT1 (NCT02966691).
The clinical trial was conducted in two phases.
Training phase: This phase allowed the development of the best algorithm using a cohort of 598 patients. View results
Testing phase: This phase was then used to evaluate and validate the performance of VisioCyt® Bladder on an independent cohort of 319 patients. View results
Partners
Want to learn more?
Our team is available to answer all your questions.
VisioCyt® Bladder (BASIC UDI-DI: 377002199701AM) is a CE IVDR Class C in vitro diagnostic medical device (Notified Body: BSI No. 02797 / Manufacturer: VitaDX International).
This IVD medical device, intended for healthcare professionals, is designed to facilitate and improve the diagnosis of urothelial carcinoma of the bladder by detecting tumor cells on digitized urinary cytology slides.
The tool aims to predict the presence or absence of bladder cancer, whether it is a low-grade or high-grade tumor.
Please read the instructions for use carefully. The analysis is not reimbursed by the national health insurance system.
No residual risks or adverse effects have been identified.
The performances of VisioCyt® Bladder are the following:
• Mean Sensitivity: 80.9 %
o Sensitivity on High-Grade cancer: 93.7 %
o Sensitivity on Low-Grade cancer: 66.7 %
• Specificity: 61.8 %
