Currently, HER2 tumor expression level determination, positive/HER2(+) or negative/HER2(−), requires direct visualization of tumor tissue over-expressing HER2 on the cell membrane using immunohistochemistry (IHC) and/or identification of its proto-oncogene (erb-b2) amplification [2] using fluorescent in-situ hybridization (FISH) or similar method. Here, ERBB2 is linked to neoplasm.