Paris-based Spotlight Medical has received CE marking under EU IVDR for myStage Dx, an AI-enabled prognostic test for ER+/HER2- early breast cancer that analyzes a standard digitized H&E-stained tissue slide alongside routine clinicopathological data to classify patients as Low Risk or Not Low Risk for distant recurrence.
The practical design is notable: myStage Dx works on tissue slides and clinical data already generated during standard care, requiring no additional lab work, specialized assays, or new equipment. It generates a binary prognostic classification to help physicians weigh treatment intensification against the risk of overtreatment.
In blinded validation studies published in the Journal of Clinical Oncology, the test identified 19.4% of patients with clinically high-risk ER+/HER2- early breast cancer as Low Risk. At nine years, 95.4% of those classified as Low Risk remained free of distant recurrence and breast cancer-related death, compared with 76.8% in the Not Low Risk group.
“The test was designed for practical integration into routine oncology and pathology workflows, using standard H&E slides and baseline clinicopathological data to provide physicians with a clear prognostic classification,” said CEO Sylvain Berlemont.
The CE marking enables European rollout across oncology centers, pathology labs, and digital pathology partners.
