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

Product name

myStage Dx

Modality

Histopathology

Main task

Biomarker identification

Subspeciality

Breast pathology

Organ/Specimen source

Breast

Disease targeted

Breast cancer

Specimen type

Not specified

Staining

H&E

Stain subtype

Not specified

Regulatory Information

CE-IVD Certification

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)

Not specified

Other certifications

Not specified

Technical Specifications

Patient population age

Adult

Input

H&E slide, clinicopathological variables (Nottingham histological grade, pathological invasive tumor size, number of pathologically confirmed positive axillary lymph nodes, and percentage of tumor cells positive for progesterone receptor)

Input format

Not specified

Output

The report includes the myStage Dx binary prognostic classification, the submitted clinical-pathology inputs used for analysis, and group-level validation context at 5 and 9 years.

Output format

Not specified

Integration

Not specified

Deployment

Not specified

Trigger for analysis

Not specified

Processing time

Not specified

Population

myStage Dx is intended for adult patients with node-positive, ER-positive, HER2-negative early breast cancer. -- myStage Dx is not intended for HER2-positive tumors, hormone receptor-negative tumors, stage IV disease at diagnosis, or cases treated with neoadjuvant chemotherapy, because treatment-induced pathological changes may confound tissue-based analysis. The test also requires sufficient usable FFPE tumor tissue for analysis.

Viewer systems

Not specified

Market Presence

On market since

Not specified

AI Platforms

Sectra Amplifier Store

Resellers

Not specified

Countries present

Not specified

Paying clinical customers

Not specified

Research/test users

Not specified

Pricing Information

Pricing model

Not specified

Based on

Not specified

Source: Public | First published: Aug 1, 2025 | Last updated: Nov 11, 2026