Artera, a developer of AI-based prognostic and predictive cancer tests, has received FDA clearance for ArteraAI Breast – a digital pathology-based risk stratification tool for patients with early-stage, hormone receptor-positive (HR+), HER2-negative invasive breast cancer.
ArteraAI Breast generates an AI-derived risk score that provides prognostic information on the likelihood of distant metastasis, using digitized histopathology images and patient clinical variables to stratify patients into low- and high-risk groups. In early-stage HR+/HER2- breast cancer, determining the appropriate intensity of therapy can be complex due to variability in clinical and pathological factors – making consistent, pathology-based risk stratification at diagnosis particularly valuable.
Data presented at the 2025 San Antonio Breast Cancer Symposium demonstrated the model’s potential to inform chemotherapy benefit in certain patient populations – meaning the tool could help identify which patients are likely to benefit from chemotherapy and which may be able to safely avoid it.
“FDA clearance for ArteraAI Breast represents a significant expansion of our FDA-cleared AI platform in oncology,” said CEO and co-founder Andre Esteva. “Breast cancer care is highly nuanced, with treatment decisions that depend on individualized risk. Our goal remains consistent: to help clinicians translate complex data into more precise, personalized treatment decisions across the cancer journey.”
“This clearance represents an important advance on the road to personalizing treatments for patients with early-stage breast cancer,” said Eric Winer, MD, director of the Yale Cancer Center. “Using AI and digital pathology has the potential to streamline operational workflows, while creating a strong interdisciplinary linkage between oncology and pathology.”
The clearance follows Artera’s earlier FDA De Novo authorization for its AI prostate cancer tool, and recent CE Marking for both the prostate and breast cancer assays – expanding the company’s regulatory footprint across the U.S. and Europe.
