The milestone advances Spotlight Medical’s European commercialisation strategy and enables implementation of myStage Dx with oncology centres, pathology laboratories and digital pathology partners.

In ER+/HER2− early breast cancer, physicians increasingly need to weigh the potential benefit of treatment intensification against long-term safety, quality of life and the risk of overtreatment. Many patients are still stratified using broad clinical and pathological criteria, which may not fully capture their individual risk of distant recurrence.

myStage Dx was developed to support more precise, physician-led risk stratification in routine care. The AI-enabled test analyzes a digitized H&E-stained FFPE whole slide image of the primary breast cancer, together with routinely available clinicopathological variables. Using predefined and explainable features, it generates a binary prognostic classification: Low Risk or Not Low Risk.