TEST:

VisioCyt®

"VitaDX...announces the signing of a strategic partnership with Biogroup, one of the largest networks of medical biology laboratories in France, with more than 900 laboratories. This partnership aims to expand the number of locations for collecting urine samples from patients for the non-invasive VisioCyt® Bladder test – the first in vitro diagnostic test developed by VitaDX."

"Avero Diagnostics...and VitaDX International...are delighted to announce the signing of a strategic partnership aimed at deploying the VisioCyt® solution. Bladder throughout the United States...The VisioCyt® Bladder solution will be available in the United States early in the first quarter of 2025."

P=N/A; N=700; Not yet recruiting; Sponsor:Institut Paoli-Calmettes

P=N/A; Trial completion date: May 2024 --> Dec 2024 | Trial primary completion date: May 2024 --> Dec 2024

VisioCyt is a promising diagnostic tool for urothelial cancers with improved sensitivities for high-grade tumors and notably for low-grade tumors.

"Urinary biomarkers might have a complementary place in bladder cancer diagnosis and NMIBC surveillance. However, their clinical benefit remains to be confirmed."

"VitaDX...announces its collaboration with XPath to continue the deployment in France of its VisioCyt® solution for the early diagnosis of cervical cancer. the bladder, the 5th most common cancer in France, with more than 13,000 new cases per year...By fully integrating into the patient's care pathway and the logistics of pathological anatomy and cytology practices, the VisioCyt® solution makes it possible, from a simple urine sample, to obtain a rapid result while significantly improving diagnostic performance."

"VitaDX...announces its collaboration with MEDIPATH...to deploy VisioCyt®, a solution for the early diagnosis of bladder cancer, the 5th most common cancer in France...This tool allows an accelerated morphological analysis of all cells present on a digitized urine cytology, in a reliable and reproducible way...It relies on artificial intelligence (machine learning and deep learning) and image processing to facilitate the early detection of bladder cancer."

The VisioCyt test greatly improves the performance of urinary cytopathology in the diagnosis of urothelial bladder tumors, particularly in low grade, pTa lesions. Its implementation could dramatically reduce the need for cystoscopy in patients followed after conservative treatment of bladder cancer.

P=N/A; Not yet recruiting --> Recruiting

P=N/A; Not yet recruiting --> Recruiting

P=N/A; Recruiting --> Completed

P=N/A; N=190; Not yet recruiting; Sponsor:Institut de Cancérologie de Lorraine

Compared to routine cytology, the first phase of VISIOCYT1 results shows very clear progress in term of sensitivity. It is particularly visible and interesting for low-grade tumours. If the validation cohort confirms these results, it could lead to the VisioCyt test being considered as a very useful aid for pathologists. Moreover, as this test is in fact software based on artificial intelligence, it should become more and more efficient as more data is collected.

P=N/A; N=1300; Recruiting; Sponsor: Vitadx; Trial completion date: Dec 2019 --> Dec 2020