The study, which was recently published in Breast Cancer Research and conducted by Karolinska Institutet in Stockholm, validates the prognostic performance of Stratipath Breast in a large retrospective cohort of over 2,700 patients from two independent clinical sites (https://doi.org/10.1186/s13058-024-01879-6)1.
Stratipath Breast builds on academic research previously published in Annals of Oncology (https://doi.org/10.1016/j.annonc.2021.09.007)2, which demonstrated the potential of AI-based risk profiling for breast cancer. The recently published validation study confirms that the CE-marked IVD medical device Stratipath Breast provides significant prognostic performance. In the clinically relevant subgroup of ER+/HER2- patients, a Hazard Ratio (HR) of 2.76 was observed between high- and low-risk groups in a multivariable Cox Proportional Hazards model adjusted for clinical factors. Additionally, in the intermediate risk group of NHG2/ER+/HER2- patients, an HR of 2.20 was observed between high- and low-risk groups. Furthermore, the study evaluated the underlying risk score as the basis for a five-level multi-group risk stratification. A marginal HR of 9.33 was observed between the reference group and the highest risk group, which constituted 20% of the population.
- The study validates the prognostic performance of Stratipath Breast in a large cohort of over 2,700 patients from two independent clinical sites.
- Significant difference in progression-free survival was noted between Stratipath Breast high- and low-risk groups particularly within the ER+/HER2- subgroup.
- The study evaluated a five-level multi-group risk stratification model with a marginal Hazard Ratio of 9.33 between the reference group and the highest risk group, representing 20% of the population.
Clinical Impact and Future Prospects
Over the past year, Stratipath Breast has been successfully implemented in clinical routine at multiple healthcare sites, where it is used daily for risk profiling of breast cancer patients. By integrating seamlessly into existing diagnostic workflows, Stratipath Breast provides healthcare providers with a faster, more affordable alternative to molecular assays, reducing both time to treatment and overall healthcare costs. Stratipath Breast is CE-IVD marked and registered in the UK, enabling its clinical use in both the EU and the UK.
“The ongoing clinical use of Stratipath Breast across several sites, combined with the recent validation study reinforces our commitment to revolutionising cancer diagnostics.” said Johan Hartman, Professor of Pathology at Karolinska Institutet and Co-founder of Stratipath. “The validation of our earlier findings using the CE-marked product highlights the reliability and effectiveness of our AI-based approach. We are proud that Stratipath Breast is already making a difference for many patients, and we look forward to expanding its use further.”
As Stratipath Breast continues to gain traction in the clinical community, ongoing and future studies will further validate its use, helping to ensure that even more patients can benefit from this advanced diagnostic tool.
