Validation of CADESS, a decision support system for malignancy grading of prostate cancer
|CADESS Medical AB
|Funding from Vinnova
|SEK 900 000
|September 2018 - August 2019
Purpose and goal
CCADESS is an AI-based decision support system for diagnosis and prognostication of prostate cancer that helps pathologists determine who can live with prostate cancer and who requires aggressive treatment to survive. By making prostate cancer diagnosis reliable, CADESS will help prolong lives and reduce healthcare costs. With the Vinnova Innovativa Startups fas 2 grant, the CADESS software and stain ready have become ready for the market by the preparation for a validation study, and by input from suitable customers/partners.
Expected results and effects
A well-conducted validation study is the key to the success of CADESS: 1. it will facilitate acceptance by pathologists and urologists; 2. it will be key in forming good partnerships; 3. it will be a central component in the FDA application; 4. it will help us make the system more reliable.
Planned approach and implementation
We prepared a validation study that will demonstrate the CADESS performance in a clinical setting. With a biostatistician we determined the required study size, and with a regulatory consultant we ensured that the study meets FDA requirements. A pilot study at the Uppsala University Hospital is underway; the final study will include large hospitals both in Europe and the US. We visited the FDA for a pre-application meeting. We also continued to develop business relationships with companies in the digital pathology market with interest in a partnership or a trade sale.