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Improved Accuracy and Consistency in Breast Cancer HER2 Scoring Using an AI-Based Diagnostic Solution: Multi-Site Validation Supporting CE-IVDR Certification

This multi-site validation study compared Manual vs. AI-assisted pathologist HER2 scoring against an expert-panel Ground Truth. Pathologists supported by AI showed significant improvements in HER2 scoring overall accuracy and consistency. The findings support AI as a transformative tool for ensuring optimal treatment pathways in routine clinical practice.

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