The first and only FDA-cleared digital pathology–based risk stratification tool in breast cancer
SAN FRANCISCO–(BUSINESS WIRE)–Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, today announced 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.
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, underscoring the company’s expanding regulatory footprint in the U.S. and Europe.
“FDA clearance for ArteraAI Breast represents a significant expansion of our FDA-cleared AI platform in oncology,” said Andre Esteva, CEO and co-founder of Artera. “This milestone reflects the growing role of our technology across multiple cancer types. Breast cancer care is highly nuanced, with treatment decisions that depend on individualized risk. Our goal remains consistent across prostate and breast cancer, and beyond: to help clinicians translate complex data into more precise, personalized treatment decisions across the cancer journey.”
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.
Data presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) evaluated the model in early-stage breast cancer and demonstrated the potential to inform chemotherapy benefit in certain patient populations.
“This clearance represents an important advance on the road to personalizing treatments for patients with early-stage breast cancer,” said Eric Winer, MD, medical oncologist and 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. This approach may further improve the clinicians’ ability to help patients make the best treatment decisions.”
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.
To learn more, visit artera.ai.
About Artera
Artera is a global leader in precision medicine, leveraging multimodal artificial intelligence (MMAI) to personalize cancer care. Artera’s MMAI platform leverages a patient’s digitized histopathology images along with the patient’s clinical data to determine cancer aggressiveness and predict therapy benefit. This approach has been validated in multiple Phase 3 randomized trials across different cancers and is available in multiple versions across the globe.
Artera’s FDA-authorized software products include ArteraAI Prostate (de novo authorization) and ArteraAI Breast (510(k) clearance). In addition, Artera has received CE Marking for its prostate and breast cancer in vitro diagnostic tests, supporting regulated availability in international markets.
Artera’s flagship product, the ArteraAI Prostate Test, is commercially available as a laboratory-developed test in the US and internationally through its distribution partners. The ArteraAI Prostate Test is the first of its kind to deliver both prognostic and predictive insights for patients with prostate cancer, empowering clinicians and patients to make more informed treatment decisions.
Artera’s headquarters is based in Los Altos, California, while its CLIA-certified and clinical laboratory is located in Jacksonville, Florida. For more information about Artera, visit artera.ai.
Contacts
Media:
Vanessa Donohue
Antenna Group
[email protected]
