Consistent with these in vitro data obtained using primary cell lines, patients harbouring USC overexpressing Her2/neu at 3+ levels were found to have significantly higher levels of Her2/neu ECD in their serum samples when compared with healthy women or patients harbouring tumours with moderate (i.e., 2+) or low/negative (i.e., 1+/negative) Her2/neu expression by IHC (P=0.02). This evidence concerns the gene ERBB2 and neoplasm.