Overview

• Prognosia Breast uses machine learning on 2D and 3D images to generate a personalized five-year breast cancer risk score from routine mammograms.
• Developed at Washington University and licensed to Prognosia Inc., the tool is reported to predict risk over two times more accurately than questionnaire-based methods.
• The FDA’s Breakthrough Device designation, awarded July 30, initiates an expedited review pathway toward full market approval.
• A clinical trial at Siteman Cancer Center will assess how integrating the AI-derived risk scores with standard screening impacts early detection.
• Risk scores of 3% or higher will trigger specialist referrals in accordance with ASCO and USPSTF preventive oncology guidelines.