Periodic Reporting for period 1 - VISIOCYT (VISIOCYT SCREENING: A DISRUPTIVE ARTIFICIAL INTELLIGENCE SOLUTION FOR BLADDER CANCER SCREENING) Reporting period: 2019-06-01 to 2019-11-30 Summary of the context and overall objectives of the project Bladder cancer is the 5th most common cancer in Europe. People at high risk for developing this disease include smokers, people living in polluted areas, and workers exposed to certain chemicals. Given the importance of early detection and the high incidence of bladder cancer, screening programs are needed to improve patient care and reduce healthcare costs. However, there are no screening programs currently dedicated to bladder cancer. VitaDX is developing VisioCyt Screening: a cloud-based software that combines artificial intelligence algorithms with cytological analysis to predict with high accuracy the presence of bladder cancer in asymptomatic patients at risk. Being a software that analyses images obtained through regular clinical procedures, VisioCyt Screening can be readily implemented in centralized labs, resulting in a fast, easy-to-use, reproducible, automated, and high-throughput solution at a low price. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far Our Feasibility Study has guaranteed the viability of the project. 1) We have identified the technical improvements for the final software and also analyzed the regulatory requirements and prerequisites of a screening program to plan the roadmap for its commercialization. We have defined the objectives of the project and prepared a complete execution plan (data gathering, algorithm development, software) for the development of VisioCyt Screening. 2) We have assessed and updated the target market, competitors, and the regulatory environment to consolidate the marketing strategy. We have been engaging KOLs and societies in the field of urology, pathology and occupational medicine. Our commercial plan and a FTO Analysis show that VisioCyt Screening is freely exploitable. 3) We have prepared a financial plan, in which we conclude that we will make direct sales through centralized labs and obtain a ROI of 1.73 and hire 151 new employees by 2027. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) VisioCyt Screening will have a positive impact on patients, general & occupational practitioners, pathologists, centralized labs and healthcare systems. Patients will benefit from increased survival rate and improve their quality of life. General & occupational practitioners, and pathologists will be equipped with an effective tool for rapid cancer screening. Centralized labs will increase their turnover by adding innovative solutions to their catalogues. Healthcare systems will benefit as effective screening reduces costly late stage treatments and follow-ups.