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.
Annals of Oncology
A published high-impact scientific article from Karolinska Institutet shows that AI-supported image analysis can stratify intermediate-grade breast cancers into low or high grade. This has strong prognostic value and potential to revolutionize breast pathology.
Study shows large variation in biomarkers and grade among Swedish pathology labs calls for AI-supported image analysis
Abstract: We compared estrogen receptor (ER), progesterone receptor (PR), human epidermal growth-factor receptor 2 (HER2), Ki67, and grade scores among the pathology departments in Sweden. We investigated how ER and HER2 positivity rates affect the distribution of endocrine and HER2-targeted treatments among oncology departments. All breast cancer patients diagnosed between 2013 and 2018 in Sweden […]