A multireader study validating the performance and utility of the Ibex Breast HER2 in scoring HER2 expression when diangosing breast cancer. Professor Savitri Krishnamurthy, MD, Professor of Pathology and Laboratory Medicine at The University of Texas MD Anderson Cancer Center,was the princiapl investigaor of the study.
A two-arm multireader study of 120 HER2 IHC whole-slide images from four sites assessed HER2 scoring by four surgical pathologists without and with the aid of an AI HER2 solution. Both arms were compared with high-confidence ground truth (GT) established by agreement of at least four of five breast pathology subspecialists according to ASCO/College of American Pathologists (CAP) 2018/2023 guidelines. The mean interobserver agreement among GT pathologists across all HER2 scores was 72.4% (N = 120). The AI solution demonstrated high accuracy for HER2 scoring, with 92.1% agreement on slides with high confidence GT (n = 92). The use of the AI tool led to improved performance by readers, interobserver agreement increased from 75.0% for digital manual read to 83.7% for AI-assisted review, and scoring accuracy improved from 85.3% to 88.0%. For the distinction of HER2 0 from 1+ cases (n = 58), pathologists supported by AI showed significantly higher interobserver agreement (69.8% without AI v 87.4% with AI) and accuracy (81.9% without AI v 88.8% with AI).
The current Ibex offering was formerly known as Galen. Please note that any mention of Galen within these materials refers to a product now known as Ibex.
