• 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.

PARIS: 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.

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.

Clinical evidence supporting myStage Dx was published in the Journal of Clinical Oncology. In blinded validation studies across the prospective CANTO and UNIRAD cohorts, 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 patients classified as Low Risk remained free of distant recurrence and breast cancer–related death, compared with 76.8% for the Not Low Risk group.

“Securing CE marking under IVDR is a major milestone for Spotlight Medical as we prepare to bring myStage Dx to clinicians across Europe,” said Sylvain Berlemont, CEO of Spotlight Medical. “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. This regulatory achievement gives us a strong foundation to support clinical adoption and to roll out myStage Dx across European hospitals.”

As part of the IVDR conformity assessment, Spotlight Medical completed a performance evaluation package addressing scientific validity, analytical performance and clinical performance, together with software verification and validation, risk management, cybersecurity, post-market surveillance and AI lifecycle documentation.

About myStage Dx

myStage Dx is a CE-marked, Class C, software-only in vitro diagnostic medical device developed by Spotlight Medical. It is intended to assess the risk of distant metastasis within nine years from diagnosis in adult patients with stage II–III, node-positive, ER-positive, HER2-negative breast cancer. The test analyzes a digitized H&E whole slide image and baseline clinicopathological variables, generating a binary prognostic classification for use by qualified physicians.

myStage Dx is intended for professional use only.

Related peer-reviewed publication

“Identifying Patients With Low Relapse Rate Despite High-Risk Estrogen Receptor–Positive/Human Epidermal Growth Factor Receptor 2–Negative Early Breast Cancer: Development and Validation of a Clinicopathologic Assay.” Bidard et al., Journal of Clinical Oncology, 2025.

About Spotlight Medical

Spotlight Medical is a French oncology diagnostics company developing evidence-driven, clinical-grade AI tests to support more precise cancer care. The company combines routine pathology, clinical data and explainable AI to develop prognostic assays designed for practical adoption in oncology workflows.

For more information, visit spotlightmedical.com and mystagedx.com.

Follow Spotlight Medical on LinkedIn.

Fonte: Business Wire