myStage Dx is a software-only, AI-based IVD prognostic tool for adults with node-positive, early-stage HR+/HER2− breast cancer. It estimates the 9-year risk of distant recurrence by analyzing a representative H&E whole-slide image of the primary tumor from a validated scanner, together with four routine clinicopathological variables:
- Nottingham grade,
- invasive tumor size,
- number of positive axillary lymph nodes,
- progesterone-receptor positivity.
The software outputs a binary classification: “Low Risk” when the predicted risk is below a pre-specified threshold, or “Not Low Risk” when it is above that threshold. In published clinical validation, 95.4% of Low Risk patients remained metastasis-free at nine years, versus approximately 77% of Not Low Risk patients.
• Application can be launched from Sectra's pathology image window: Yes
• Results will be shown in Sectra's pathology image window: Yes
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The application content is provided by the respective AI vendors.