Beyond ERBB2 amplification: RNA and proteomic HER2 assessment for pan-tumor treatment stratification

HER2-directed therapies are expanding across solid tumors, but ERBB2 amplification incompletely captures HER2 expression and pan-tumor IHC lacks standardization. We developed ERBB2 mRNA, bulk HER2 protein and RNA-signature screening benchmarked against IHC/FISH. Screening identified HER2-enriched populations beyond amplification in a pan-tumor discovery cohort of 1,331 tumor biopsies and validated RNA-based screening in an external cohort of 3,898 tumor biopsies. All six objective responses among 51 treated patients in the discovery cohort occurred in tumors positive by ERBB2 mRNA and the comb

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