Artera receives FDA Clearance for breast cancer platform

Artera has won FDA clearance for ArteraAI Breast, its breast cancer platform for patients with early-stage HR-positive, HER2-negative invasive breast cancer.

ArteraAI Breast is the first and only FDA-cleared digital pathology-based risk stratification tool for breast cancer.

These FDA milestones come alongside recent CE marking for both the ArteraAI Prostate Biopsy Assay and the ArteraAI Breast Cancer Assay in the US and Europe.

“FDA clearance for ArteraAI Breast represents a significant expansion of our FDA-cleared AI platform in oncology,” said Andre Esteva, chief executive 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 individualised risk.

“Our goal remains consistent across prostate and breast cancer, and beyond: to help clinicians translate complex data into more precise, personalised treatment decisions across the cancer journey.”

ArteraAI Breast generates an AI-derived risk score showing the likelihood of distant metastasis, meaning cancer spreading to another part of the body, in patients with early-stage HR-positive, HER2-negative breast cancer.

Using digitised histopathology images, which are scanned tissue sample images, alongside patient clinical variables, the model sorts patients into low-risk and high-risk groups based on a predefined risk score cut-off.

In early-stage HR-positive, HER2-negative breast cancer, deciding the right intensity of treatment can be complex because clinical and pathological factors vary. Artera said the tool is designed to support clinicians within established decision-making frameworks.

Data presented at the 2025 San Antonio Breast Cancer Symposium 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 personalising treatments for patients with early-stage breast cancer,” said Eric Winer, 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 laboratories to give clinicians patient-specific prognostic risk information alongside standard histopathology reports.