Public source
Reviewed 11 Nov 2026
Completeness Good (47%)
myStage Dx is an 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. Source (https://amplifiermarketplace.sectra.com/pathology/mystage-dx/)
Supported by 1 paper
Key features
Biomarker prediction
General Information
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Disease targeted
Specimen type
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Staining
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Regulatory Information
Pathway:
In Vitro Diagnostic Regulation (IVDR)
Class:
Class C
Not verified by Health AI Register
Scanner Brands Certified for Use (CE-IVD)
Not specified
Scanner Models Certified for Use (CE-IVD)
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Other certifications
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Technical Specifications
Patient population age
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Output
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Integration
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AI Platforms
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Pricing Information
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Source: Public | First published: Aug 1, 2025 | Last updated: Nov 11, 2026