Press release, Stockholm, Sweden, – Stratipath today announced that 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.
TAILORx is one of the largest prospective randomised clinical trials in early breast cancer. Validation within this study represents a significant milestone for Stratipath Breast as a CE-marked AI-based clinical decision-support tool for prognostic risk stratification of early breast cancer.
In this study, histopathology whole slide images from 5,519 patients enrolled in TAILORx were analysed by Stratipath Breast. Results confirmed a significant association of Stratipath Breast risk stratification with both recurrence-free interval (RFI) and distant recurrence-free interval (DRFI).
In multivariable Cox proportional hazard analysis — adjusting for age, tumour size, histological subtype, and Oncotype DX recurrence score (RS)— Stratipath Breast high-risk category was an independent prognostic factor associated with worse outcomes (RFI HR = 1.54; DRFI HR = 1.61, p < 0.05).
Key finding from the TAILORx validation study:
-
- Stratipath Breast provides independent prognostic value. In a multivariable analysis of 5,519 patients, Stratipath Breast was an independent prognostic factor for both RFI and DRFI, when adjusting for standard clinicopathological variables and Oncotype DX recurrence score.
The TAILORx validation results provide compelling evidence for the prognostic value of Stratipath Breast at a scale and level of rigor that is rarely matched in AI-based diagnostics,” said Professor Johan Hartman. “The finding that our AI-based risk stratification adds independent prognostic information beyond both standard clinicopathological variables and the Oncotype DX recurrence score is particularly significant, and strengthens the clinical case for integrating AI morphology-based biomarkers into breast cancer management.”
Stratipath Breast is a CE-IVD marked medical device that analyses routine H&E-stained histopathology whole slide images to provide binary and multi-level risk stratification for early-stage breast cancer. The solution requires no additional tissue processing, staining, or laboratory workflow changes, and delivers results directly from the existing diagnostic pathology pipeline.
The TAILORx validation adds to a growing body of clinical evidence for Stratipath Breast, which has previously been validated in independent cohorts including data published in Breast Cancer Research (Sharma et al., 2024), Breast Cancer Research and Treatment (Wang et al., 2024), and The Breast (Pouplier et al., 2025).
The poster abstract is available through the ASCO 2026 Annual Meeting program: https://www.asco.org/abstracts-presentations/265863