Reflex test must be ordered with alternative test on the same specimen, or either of the tests on a new specimen.IHC:1. HER2 2+ on basis of moderate/weak and/or incomplete circumferential membrane staining of > 10% invasive tumor cells.2. HER2 2+ on basis of intense, complete and circumferential staining of ≤ 10% invasive tumor cells;ISH:1. Single probe system with average number of HER2 copies < 6 and ≥ 4 signals per cell.2. Dual probe system with HER2/CEP17 ratio of < 2.0 and average number of HER2 copies < 6 and ≥ 4 signals per cell. Here, ERBB2 is linked to neoplasm.