Ashok, M. (2009). Analysis of HER2 testing in breast cancer; Disparities, cost effectiveness, and patterns of care [dissertation thesis]. Georgia Institute of Technology
Bond™ Oracle™ HER2 IHC System for Leica BOND-MAX System [Instructions for use]. (2014). Leica Microsystems
CAP Commission on Laboratory Accreditation: Laboratory Accreditation Program. (2023). Anatomic Pathology Accreditation Checklist. College of American Pathologists.
Carter, C., Allen, C., & Henson, D. (1989). Relation of tumor size, lymph node status, and survival in 24,740 breast cancer cases. Cancer. 63:181-187
Clinical and Laboratory Standards Institute. Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays. 2nd ed. CLSI document I/LA28-A2. Wayne, PA: CLSI; 2011
Duffy M. J. (2005). Predictive markers in breast and other cancers: a review. Clinical chemistry, 51(3), 494–503. https://doi.org/10.1373/clinchem.2004.046227
Gordian-Arroyo, A. M., Zynger, D. L., & Tozbikian, G. H. (2019). Impact of the 2018 ASCO/CAP HER2 Guideline Focused Update. American Journal of Clinical Pathology, 152(1), 17–26. https://doi.org/10.1093/ajcp/aqz012
Hammond, M. E., Hayes, D. F., et al. (2010). American Society of Clinical Oncology/College Of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. Journal of clinical oncology: official journal of the American Society of Clinical Oncology, 28(16), 2784–2795. https://doi.org/10.1200/JCO.2009.25.6529
Hardy, L. B., Fitzgibbons, P. L., Goldsmith, J. D., Eisen, R. N., Beasley, M. B., Souers, R. J., & Nakhleh, R. E. (2013). Immunohistochemistry validation procedures and practices: a College of American Pathologists survey of 727 laboratories. Archives of pathology & laboratory medicine, 137(1), 19–25. https://doi.org/10.5858/arpa.2011-0676-CP
Hartman, A. K., Gorman, B. K., Chakraborty, S., Mody, D. R., & Schwartz, M. R. (2014). Determination of HER2/neu status: a pilot study comparing HER2/neu dual in situ hybridization DNA probe cocktail assay performed on cell blocks to immunohistochemisty and fluorescence in situ hybridization performed on histologic specimens. Archives of pathology & laboratory medicine, 138(4), 553–558. https://doi.org/10.5858/arpa.2013-0314-SA
Nakhleh, R., & Fitzgibbons, P. (2005). Quality management in anatomic pathology: Promoting patient safety through systems improvement and error reduction. College of American Pathologists.
Wolff, A. C., Hammond, M. E., Allison, K. H., et al. (2018). Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. Archives of pathology & laboratory medicine, 142(11), 1364–1382. https://doi.org/10.5858/arpa.2018-0902-SA
Wolff, A. C., Hammond, M. E., Schwartz, J. N., et al. (2007). American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. Journal of clinical oncology: official journal of the American Society of Clinical Oncology, 25(1), 118–145. https://doi.org/10.1200/JCO.2006.09.2775
Wolff, A. C., Somerfield, M. R., Dowsett, M., Hammond, M. E. H., Hayes, D. F., McShane, L. M., Saphner, T. J., Spears, P. A., & Allison, K. H. (2023). Human Epidermal Growth Factor Receptor 2 testing in breast Cancer: ASCO–College of American Pathologists Guideline update. Journal of Clinical Oncology, 41(22), 3867–3872. https://doi.org/10.1200/jco.22.02864
Yeh I. T. (2002). Measuring HER-2 in breast cancer. Immunohistochemistry, FISH, or ELISA?. American journal of clinical pathology, 117 Suppl, S26–S35. https://doi.org/10.1309/D76M-QEGU-62BT-HKER