{"entity":{"id":"artera-ai-breast","kind":"drug","name":"ArteraAI Breast","aka":[],"tldr":"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.","status":"approved","asOf":"2026-09-04","links":[{"label":"Artera: ArteraAI tests","url":"https://artera.ai/"}],"tags":[],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["digital-pathology-ai","pathology-foundation-model"],"targets":[],"drugs":[],"companies":["artera"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"modality":"AI digital pathology risk test","mechanism":"Foundation-model-derived features from H&E whole-slide images.","approvals":[{"region":"US","year":2026,"indication":"Risk stratification in early-stage HR+/HER2- invasive breast cancer"}],"mechanismSteps":["H&E whole-slide images are scanned","Foundation-model features are extracted","Recurrence risk is predicted for early HR+/HER2- disease","Result complements or replaces gene-expression assays"],"toxicity":[],"access":[{"country":"US","reimbursement":"Launched May 2026; coverage determinations pending","source":"https://artera.ai","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2026-05","type":"approval","region":"US","note":"FDA clearance: first digital-pathology-based risk stratification tool for early HR+/HER2- breast cancer","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/artera-ai-breast/","neighbours":{"cancer":[{"id":"hr-positive-early-high-risk","kind":"cancer","name":"High-risk early HR-positive breast cancer","route":"/cancers/hr-positive-early-high-risk/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"technology":[{"id":"digital-pathology-ai","kind":"technology","name":"Digital pathology & AI","route":"/technologies/digital-pathology-ai/"},{"id":"pathology-foundation-model","kind":"technology","name":"Pathology & radiology foundation models","route":"/technologies/pathology-foundation-model/"}],"company":[{"id":"artera","kind":"company","name":"Artera","route":"/companies/artera/"}],"idea":[{"id":"idea-multimodal-foundation-model","kind":"idea","name":"Patient-level multimodal foundation models for treatment selection","route":"/ideas/idea-multimodal-foundation-model/"}],"bottleneck":[{"id":"b-ai-validation","kind":"bottleneck","name":"AI that is built but not validated or deployed","route":"/bottlenecks/b-ai-validation/"}],"roadmap":[{"id":"ai-oncology-roadmap","kind":"roadmap","name":"AI in oncology roadmap: pattern readers → foundation models → agents in the workflow","route":"/roadmaps/ai-oncology-roadmap/"},{"id":"ai-oncology-clinic","kind":"roadmap","name":"AI in the oncology clinic: from narrow cleared tools to multimodal decision support","route":"/roadmaps/ai-oncology-clinic/"},{"id":"diagnostics-roadmap","kind":"roadmap","name":"Diagnostics roadmap: stains → gene panels → blood tests that decide treatment","route":"/roadmaps/diagnostics-roadmap/"}]}}