newsio aggregates and links to original sources. We do not own the original images or content. If you believe content infringes on intellectual property rights, contact us — it will be removed at first notice.
biotech/news//Medical Xpress
The U.S. Food and Drug Administration has cleared ArteraAI Breast for use in patients with early-stage, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative invasive breast cancer.
ArteraAI Breast is the first FDA-cleared digital pathology-based risk stratification tool for breast cancer.
KEY POINTS
The AI tool predicts risk of distant metastasis using digitized histopathology images and clinical variables.
ArteraAI Breast integrates into standard pathology workflows, requiring no additional tissue collection.
In studies, 68% of patients were classified as low-risk with a 95% 10-year metastasis-free survival.
The U.S. Food and Drug Administration has cleared ArteraAI Breast for use in patients with early-stage, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative invasive breast cancer.
The multimodal artificial intelligence-based prognostic and predictive cancer test is the first and only FDA-cleared digital pathology-based risk stratification tool for breast cancer. ArteraAI Breast generates a risk score that predicts a low or high likelihood of distant metastasis in patients with early-stage HR-positive/HER2-negative breast cancer based on digitized histopathology images and patient clinical variables. The tool is designed to integrate directly into standard pathology workflows using routine surgical resection samples, without requiring additional tissue or separate specimen collection.
The approval is based on previously presented data. In one poster presentation (12,000 patients across six phase 3 clinical trials), the model stratified patients by 10-year risk for distant metastasis. Identified high-risk individuals were recommended for closer monitoring, while 68% of patients were classified as low-risk and achieved an estimated 10-year distant metastasis-free survival of approximately 95%.
"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, CEO and cofounder of Artera, said in a statement.