FDA Clears AI Stratification Tool in HR+/HER2– Invasive Breast Cancer

The FDA has cleared ArteraAI Breast, digital pathology-based risk stratification tool, for use among patients with early-stage, hormone receptor (HR)–positive, HER2-negative invasive breast cancer, according to a press release from the developer, Artera.¹

Developers designed ArteraAI Breast to generate AI-assisted risk scores that show prognostic information on the risk of distant metastasis among those with early-stage breast cancer. Based on digitized histopathology images and patient clinical variables, the model can stratify patients into low- and high-risk groups using a predefined risk score cutoff. With the ability to provide pathology-based risk stratification around the time of diagnosis, the platform may assist clinicians with contextualizing risks within established clinical frameworks.

“This clearance represents an important advance on the road to personalizing treatments for patients with early-stage breast cancer. Using AI and digital pathology has the potential to streamline operational workflows, while creating a strong interdisciplinary linkage between oncology and pathology,” Eric Winer, MD, medical oncologist and director of the Yale Cancer Center, stated in the press release.¹ “This approach may further improve the clinicians’ ability to help patients make the best treatment decisions.”

The multimodal artificial intelligence (MMAI) platform uses a unique algorithm that leverages both digital images from a patient’s resection as well as their clinical data.² Developers designed the algorithm based on thousands of patients and tens of thousands of pathology slides, which has been validated with multiple phase 3 trial results across different patient cohorts.

Across 9 phase 3 breast cancer trials, ArteraAI breast demonstrated prognostic value in predicting distant metastasis risks in patients with HR-positive early-stage breast cancer while helping clinicians with treatment decision-making. According to the developers, test results can be shared within 1 to 2 days after collecting a sample from a patient’s resection, with no risk of inconclusive results based on insufficient tissues samples. Developers also noted that the test demonstrated strong independent prognostic and predictive performance for chemotherapy benefit among patients in the NSABP B-20 trial. In this cohort, patients classified as MMAI low derived no benefit from added chemotherapy, while those classified as MMAI high experienced a substantial benefit.

Developers previously shared findings demonstrating the prognostic and predictive utility of their MMAI model at the 2025 San Antonio Breast Cancer Symposium (SABCS).³ In one presentation assessing data on more than 12,000 patients enrolled across 6 phase 3 trials, the model effectively sorted patients based on 10-year risk of distant metastasis. Additionally, 68% of patients classified as low risk experienced a 10-year distant metastasis-free survival rate of approximately 95%.

In another presentation focusing on postmenopausal patients in the ABCSG 8 trial (NCT00291759), the MMAI platform successfully sorted patients into low-, intermediate-, and high-risk groups, with respective 10-year distant metastasis-free survival rates of approximately 95%, 89%, and 77%. According to another presentation on patients with node-negative, HR-positive disease in the NSABP B-20 trial, patients sorted into the MMAI high-risk group experienced a 52% relative decrease in 10-year distant metastasis rates with chemotherapy.

“FDA clearance for ArteraAI Breast represents a significant expansion of our FDA-cleared AI platform in oncology. 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,” Andre Esteva, chief executive officer and co-founder of Artera, concluded.¹

References

1. Artera receives U.S. FDA clearance for ArteraAI Breast, expanding its AI platform to breast cancer. News release. Artera. May 6, 2026. Accessed May 6, 2026. https://tinyurl.com/w6u8vv6c
2. Rethink what’s possible in breast cancer testing. Artera. Accessed May 6, 2026. https://tinyurl.com/4r9hb2xt
3. Artera unveils data demonstrating prognostic and predictive utility in breast cancer at SABCS 2025. News release. Artera. November 24, 2025. Accessed May 6, 2026. https://tinyurl.com/4c9hk66x