Stratipath Breast Achieves CE Marking Under IVDR, Reinforcing Its leading position in AI-Based Breast Cancer Precision Diagnostics

Stratipath, today announced that Stratipath Breast has received CE marking under the In Vitro Diagnostic Regulation (IVDR, EU 2017/746), the EU’s most stringent regulatory framework for in vitro diagnostic medical devices. The certification confirms that Stratipath Breast meets the highest standards for clinical evidence, analytical validity, and post-market surveillance, and marks a natural next step in the product’s regulatory journey.

Stratipath Breast Validated in TAILORx Presented at ASCO 2026

New validation data for prognostic performance of Stratipath Breast in the landmark TAILORx trial will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2026 in Chicago. The data will be presented by Johan Hartman, MD PhD, Professor of Tumour Pathology at Karolinska Institutet and Co-founder of Stratipath.

new validation data for prognostic performance of Stratipath Breast in the landmark TAILORx trial will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2026 in Chicago. The data will be presented by Johan Hartman, MD PhD, Professor of Tumour Pathology at Karolinska Institutet and Co-founder of Stratipath.

Stratipath
Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful. More information about our Cookie Policy and Privacy policy.