# ArteraAI Breast

Source: https://onco.cc/drugs/artera-ai-breast/  
OnCo record `artera-ai-breast` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

An FDA-cleared AI test (May 2026) that reads breast cancer slides to estimate recurrence risk in early hormone-positive disease.

## Summary

ArteraAI Breast is an AI digital pathology test that extracts foundation-model-derived features from H&E whole-slide images to estimate recurrence risk in early-stage HR-positive, HER2-negative invasive breast cancer. FDA-cleared in May 2026, it is the first digital-pathology-based risk stratification tool for this setting and is positioned as a faster and cheaper alternative to gene-expression assays such as Oncotype DX, because it needs only the slide already made for diagnosis rather than a separate laboratory send-out. It is cleared for prognosis; whether it also predicts chemotherapy benefit, as TAILORx established for the 21-gene score, has not been shown. Performance across scanners, laboratories and populations will decide how widely it is adopted. For a newcomer: software that reads the routine pathology slide to judge how likely a hormone-positive breast cancer is to return.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-04
- Modality: AI digital pathology risk test
- Mechanism: Foundation-model-derived features from H&E whole-slide images.
- Approvals: US 2026: Risk stratification in early-stage HR+/HER2- invasive breast cancer

## Sources

- Artera: ArteraAI tests: https://artera.ai/

## Connected records

- cancers: [High-risk early HR-positive breast cancer](https://onco.cc/cancers/hr-positive-early-high-risk/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- technologies: [Digital pathology & AI](https://onco.cc/technologies/digital-pathology-ai/), [Pathology & radiology foundation models](https://onco.cc/technologies/pathology-foundation-model/)
- companies: [Artera](https://onco.cc/companies/artera/)
- ideas: [Patient-level multimodal foundation models for treatment selection](https://onco.cc/ideas/idea-multimodal-foundation-model/)
- bottlenecks: [AI that is built but not validated or deployed](https://onco.cc/bottlenecks/b-ai-validation/)
- roadmaps: [AI in oncology roadmap: pattern readers → foundation models → agents in the workflow](https://onco.cc/roadmaps/ai-oncology-roadmap/), [AI in the oncology clinic: from narrow cleared tools to multimodal decision support](https://onco.cc/roadmaps/ai-oncology-clinic/), [Diagnostics roadmap: stains → gene panels → blood tests that decide treatment](https://onco.cc/roadmaps/diagnostics-roadmap/)

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