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Current reference methods for evaluating gene amplification and expression of ERBB2 (also known as HER-2)--cell-based fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC)--are subjective and influenced by methods of tissue preparation and fixation. We developed and evaluated a novel, quantitative liquid-based FISH (L-FISH) assay that uses flow cytometry to detect ERBB2 gene amplification in breast cancer patients.

Liquid-Based Fluorescence In Situ Hybridization Assay for Detection of ERBB2 Gene Amplification in Patients with Breast Cancer3