ERBB2 and neoplasm: In our experience, three major points have to be satisfied for the standardization of molecular methods: (i) the supervision of sample selection by an experienced pathologist, to assure that a suitable amount of infiltrating tumor cells is analyzed and that in situ carcinoma, potentially overexpressing HER2 [50, 51], is not included in the specimen; (ii) a strict control of the quantity and quality of DNA/RNA extracted; (iii) the use of extensively validated PCR analysis algorithms to measure the DNA/RNA templates in the tumor samples [19].