Background: Identification of HER2 protein overexpression and/or amplification of the gene are required to qualify breast cancer patients for HER2 targeted therapies. hybridization (ISH) assays that identify gene amplification function as a stand-alone test for determination of HER2 status and rely on the manual quantification of the number of genes and copies of chromosome 17 to determine amplification.
Methods: To assist pathologists, we have developed the uPath HER2 Dual ISH Image Analysis for Breast (uPath HER2 DISH IA) algorithm, as an adjunctive aid in the determination of gene status in breast cancer specimens.