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Using an individual cell ratio >= 4 to define significantly amplified (“High-ICR”) cells, the following diagnostic categories are proposed: uniformly amplified (defined as having >90% High-ICR cells), uniformly non-amplified (<10% High-ICR cells and heterogeneous with X% amplified cells (10-90% of High-ICR cells).
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Discussion: Intratumoral heterogeneity for HER2 gene amplification is common in amplified, non-amplified and equivocal cases by current reporting guidelines but not all heterogeneity is likely to be clinically significant. The High-ICR scoring system categorizes cases based on the number of cells with significant amplification, eliminates the problematic equivocal category. and directly reports the fraction of cells that are presumed to be most amenable to treatment. We propose that the High-ICR reporting system be further validated and adopted for clinical use.