FDA clears Artera’s digital pathology-based risk stratification tool for breast cancer
Artera has been granted U.S. Food and Drug Administration (FDA) clearance of ArteraAI Breast for use in patients with early-stage, hormone receptor-positive (HR+), HER2-negative invasive breast cancer, according to an announcement.
ArteraAI Breast is the first and only FDA-cleared digital pathology-based risk stratification tool for breast cancer. With clearances in both prostate and breast cancer, Artera continues to expand its platform across additional oncology indications.
These FDA milestones come alongside recent CE Marking for both the ArteraAI Prostate Biopsy Assay and the ArteraAI Breast Cancer Assay.
ArteraAI Breast generates an AI-derived risk score that provides prognostic information on the likelihood of distant metastasis in patients with early-stage HR+/HER2- breast cancer. Using digitized histopathology images and patient clinical variables, the model stratifies patients into low- and high-risk groups based on a predefined risk score cutoff.
In early-stage HR+/HER2- breast cancer, determining the appropriate intensity of therapy can be complex due to variability in clinical and pathological factors. By providing consistent, pathology-based risk stratification at the point of diagnosis, ArteraAI Breast is designed to support clinicians in contextualizing risk within established clinical decision-making frameworks.
ArteraAI Breast is designed to integrate directly into standard pathology workflows using routine surgical resection samples, without requiring additional tissue or separate specimen collection. This approach allows the software to provide same-day results, enabling pathology labs to provide clinicians with patient-specific prognostic risk information alongside standard histopathology reports.
