# 美國食品藥物管理局已核准ArteraAI Breast用於早期、荷爾蒙受體(HR)陽性、人類表皮生長因子受體2(HER2)陰性侵襲性乳癌患者。

*biotech · news · 2026-05-12 · Medical Xpress*

## Key points

- ArteraAI Breast是首個獲FDA核准的基於數位病理的乳癌風險分層工具。
- 該AI工具利用數位化組織病理影像及臨床變數預測遠端轉移風險。
- ArteraAI Breast可整合至標準病理工作流程，無需額外組織採集。
- 研究中，68%的患者被分類為低風險，且10年無轉移存活率達95%。

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.

**Companies:** Artera
**Countries:** United States

[Read the full story on Medical Xpress](https://medicalxpress.com/news/2026-05-fda-arteraai-breast-cancer-stratification.html)

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