HER2/neu Testing In 432 Consecutive Breast Cancer Cases using FISH and IHC - A Comparative StudyCorrespondence Address :
Dr. Imran Gorur Mohammed,
Consultant Pathologist, Triesta Reference Laboratory (TRL),
Unit of HealthCare Global Enterprise Ltd (HCG) 8, P. Kalinga Rao Road,
Sampangiram Nagar, Bengaluru-560027, Karnataka, India.
Introduction: The development of trastuzumab, a HER-2/neu targeted monoclonal antibody resulted in significant improvements in clinical response and survival in HER-2/neu gene amplified group of patients. Thus, accurate assessment of HER-2/neu status becomes critical. Fluorescence In Situ Hybridization (FISH) and Immunohistochemistry (IHC) are the most commonly used methods for this purpose and specific recommendations exist with regard to the concordance to be observed between the two tests.
Aim: Here, we report and evaluate the concordance rate between FISH and IHC for HER-2/neu status in breast cancer specimens.
Materials and Methods: Archival paraffin blocks of tumour tissue from 450 patients of breast cancer were analyzed for Her-2/neu status using FISH and IHC.
Results: There was a highly significant concordance between the results of FISH and IHC assays in HER-2/neu status assessment in invasive breast cancer cases. There were inverse associations between the expression of Oestrogen Receptors/Progesterone Receptors (ER/PR) and HER-2/neu amplification.
Conclusion: Although, IHC gave significant concordant results with FISH in determining HER-2/neu status, its subjective grading system precludes its use as a gold standard. FISH should always be used to determine true gene amplification when the IHC results are equivocal.
Concordance, Molecular Diagnostics, Theranostics
Venkataswamy Eswarachary, Imran Gorur Mohammed, Prashanth K Jayanna, Geeta V PatilOkaly, Ashwini R Nargund, Gopal Krishna Dhondalay, et al.. HER2/NEU TESTING IN 432 CONSECUTIVE BREAST CANCER CASES USING FISH AND IHC - A COMPARATIVE STUDY. Journal of Clinical and Diagnostic Research [serial online] 2017 April [cited: 2017 Mar 28 ]; 11:EC01-EC05. Available from
Date of Submission: Dec 01, 2016
Date of Peer Review: Dec 26, 2016
Date of Acceptance: Jan 20, 2017
Date of Publishing: Apr 01, 2017
Financial OR OTHER COMPETING INTERESTS: None.
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