Objective To explore the effect of CISH on detecting gene amplification of HER-2 in breast cancer and to compare the results with those obtained by immunohistochemistry(IHC).Methods CISH for HER-2 gene expression was performed using SPOT-Light HER2 CISHTM on the archival paraffin-embedded sections of breast cancer tissues from 40cases with immunohistochemical staining scores of(+++),(++),(+).Results Of the 15 cases with score(+++) by IHC,14 cases showed HER-2 gene amplification by CISH,1 case CISH-negative.11 of the 16 cases with score (++) showed HER-2 gene amplification,the remaining 5 cases were CISH-negative.9 cases with score(+) were CISH-negative.Certain difference to the examination of HER-2 was found in the two kinds of method(P0.05).Conclusion Immunohistochemistry(IHC) is the first choice in primary screening for HER-2 expression status.Because of the obvious discrepancies between protein expression and gene amplification,patients with score(+~+++) by IHC should undergo CISH testing.