Stratipath Breast is the first EU regulatory compliant solution for risk stratification of breast cancer using AI-based precision diagnostics to analyse cancer tissue, and enabling identification of patients with increased risk of disease progression.
In contrast to traditional molecular tests, AI-based risk stratification enables faster turnaround times for results, provides new information at the point of diagnosis and reduces the need for expensive molecular testing, allowing for wider use and benefit to more patients.
Histological tumour grade is a strong prognostic indicator of breast cancer. Grading of invasive breast cancer is performed on all invasive breast cancers based on morphological assessment, according to the Nottingham Histologic Grade (NHG), resulting in the low- to high-risk categories NHG 1, 2 or 3. But currently, more than 50% of all breast cancer patients are categorised as of intermediate risk (i.e NHG 2), which provides little clinical utility for treatment decision-making. The consequential over- and undertreatment of patients with early breast cancer has become one of the main challenges for treating physicians, and the clinical decisions are often dependent on expensive molecular assays that are not accessible to the majority of patients.
Using deep learning, Stratipath Breast enables cancer detection and classification of intermediate risk tumours into low- and high-risk groups, based on grade-related tumour morphology. The stratification comes from a rigorous scientific development process and validation using multi-source real-world datasets, comprising histopathology images and associated clinical outcome data.
The system measures risk-associated morphological patterns locally in the image and aggregates this information across the analysed tissue area to establish whether the tumour belongs to the high- or low-risk group. Results from Stratipath Breast provide prognostic information and are intended to be used as a decision support tool, together with other clinical and pathological information.
Stratipath Breast provides an optimal workflow through integration with leading digital pathology solutions. It can also be used on its own, via the Stratipath customer web portal. Access to Stratipath Breast will be provided as a Software as a Service solution, by a subscription or pay as you use model.