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An FDA-cleared AI test (May 2026) that reads breast cancer slides to estimate recurrence risk in early hormone-positive disease.
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.
Foundation-model-derived features from H&E whole-slide images.
1.H&E whole-slide images are scanned
Newer test; no Medicare coverage determination had been published at the time of writing. Check the MolDX programme for a current decision.
Commercial coverage not yet established.
Sources: CMS Medicare Coverage Database (NCDs and LCDs) · CMS Medicare Coverage Database (NCDs and LCDs). Not medical or financial advice; verify with your plan.
Sources: NICE search: ArteraAI Breast. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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FDA clearance: first digital-pathology-based risk stratification tool for early HR+/HER2- breast cancer source
| Region | Year | Indication |
|---|---|---|
| US | 2026 | Risk stratification in early-stage HR+/HER2- invasive breast cancer |
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Launched May 2026; coverage determinations pending | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Query for this drug: (TITLE:"ArteraAI Breast" OR ABSTRACT:"ArteraAI Breast") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about ArteraAI Breast, not a curated reading list.
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