The software analyzes digitized tissue slides to help clinicians assess the risk of recurrence in patients with early-stage disease.
Spotlight Medical announced that its myStage Dx test, a prognostic test for ER+/HER2 early breast cancer, has received CE marking under the European Union In Vitro Diagnostic Medical Devices Regulation (IVDR). The milestone enables the implementation of the AI-enabled test with oncology centers, pathology laboratories, and digital pathology partners across Europe.
The test is intended for use in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) early breast cancer. It is designed to help physicians determine the risk of distant recurrence and avoid potential overtreatment.
The software analyzes a digitized hematoxylin and eosin (H&E)-stained formalin-fixed paraffin-embedded whole slide image of the primary cancer, along with routinely available clinicopathological variables. Using predefined features, it generates a binary classification of Low Risk or Not Low Risk.
“Securing CE marking under IVDR is a major milestone for Spotlight Medical as we prepare to bring myStage Dx to clinicians across Europe,” says Sylvain Berlemont, CEO of Spotlight Medical, in a release. “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.”
Clinical evidence supporting the test was published in the Journal of Clinical Oncology. In blinded validation studies across the CANTO and UNIRAD cohorts, the test identified 19.4% of patients with clinically high-risk disease 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.
The conformity assessment for the IVDR marking included a performance evaluation of scientific validity, analytical performance, and clinical performance. The process also included software verification and validation, risk management, cybersecurity, and post-market surveillance documentation.
ID 27610056 | Test © Viktorus | Dreamstime.com
