1. BREAST CANCER Requirements- Time to fixation < or = 1hr - Fixed in 10% Neutral Buffered Formalin (NBF)- Fixed in 10% NBF for at least 6 hours and less than 72 hours
ALLThe clone used is a mouse monoclonal, CB11 and detection system used is a polymer based. This test is validated on paraffin-embedded, 10% neutral formalin fixed tiossues. Interpretation follows the American Society for Clinical Oncology (ASCO) and College of American Pathologists (CAP) guidelines.
1. Reference: Wolff AC, Hammond ME, Allison KH, Harvey BE, Mangu PB, Bartlett JM, Bilous M, Ellis IO, Fitzgibbons P, Hanna W, Jenkins RB, Press MF, Spears PA, et al. Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. J Clin Oncol. 2018;36:2105–22.
2. Walker Ra, Bartlett JMS Dowsett M, Ellis IO, Hanby An, Jasani B, Miller K, and Pinder SE. HER2 Testing in the UK-Further Update to Recommendations. Journal of Clinical Pathology 2008.
3. Yaziji H, Goldstein LC, Barry TS, Werling R, Hwang H, Ellis GK, Gralow JR, Livingston RB, Gown AM: HER-2 testing in breast cancer using parallel tissue-based methods. JAMA 2004, 291:1972-1977.
4.Owens MA, Horten BC, Da Silva MM: HER2 amplification ratios by fluorescence in situ hybridization and correlation with immunohistochemistry in a cohort of 6556 breast cancer tissues. Clin Breast Cancer 2004, 5:63-69.
5. Hofmann M et al, Assessment of a HER2 scoring system for gastric cancer: results from a validation study. Histopathol 52:797. 2008.
6. Bang Y et al, Pathologic features of advanced gastric cancer (GC): relationship to human epidermal growth factor receptor 2 (HER2) positivity in the global screening programme of the ToGA trial. J Clin Oncol 25:15s (suppl; abstr 4556).