Machine learning models to quantify HER2 for real-time tissue image analysis in prospective clinical trials

Patient eligibility for HER2-targeting treatments is commonly informed by testing tumor HER2 expression using immunohistochemistry. As HER2 expression is visually assessed by pathologists, inter- and intra-rater variability might affect treatment decisions. Here, we report the development of an automated machine learning (ML)-based algorithm to quantify HER2 cell membrane expression across a diversity of breast cancer phenotypes as a clinical tool for monitoring HER2 testing quality.