Spotlight Medical Secures IVDR CE Marking for myStage Dx, Its AI-Enabled Prognostic Test for ER+/HER2 – Early Breast Cancer
Class C software-only IVD supports European rollout of a JCO-published assay designed to bring clinically validated prognostic assessment into routine breast cancer care.
Spotlight Medical, a Paris-based oncology diagnostics company, today announced that myStage Dx has received CE marking under the European Union In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746).
The milestone advances Spotlight Medical’s European commercialization strategy and enables implementation of myStage Dx with oncology centers, 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.
