HER2, Breast, Quantitative Immunohistochemistry, Automated
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
The HER2 (official gene name ERBB2) proto-oncogene encodes a membrane receptor with tyrosine kinase activity and homology to the epidermal growth factor receptor.
Amplification and overexpression of the HER2 gene in human breast, endometrial, ovarian, and other epithelial cancers have been associated with a shorter disease-free interval and shorter overall survival. Overexpression of HER2 protein is an indication for Herceptin therapy in patients with breast cancer.
Determining overexpression of HER2 protein on formalin-fixed, paraffin-embedded tissue sections
This FDA-approved test is most frequently used to evaluate HER2 overexpression in breast cancer.
Results are reported as negative (0, 1+), equivocal (2+), and strongly positive (3+) according to the interpretation guidelines for the FDA-approved Ventana Pathway HER2 (4B5) antibody.
The scoring method using the Aperio digital pathology system was developed and validated in the Molecular Anatomic Pathology Laboratory, Department of Laboratory Medicine and Pathology, Mayo Clinic (see Method Description).
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
The performance and quality of immunohistochemical stains in formalin-fixed, paraffin-embedded tissue depends critically on proper fixation.
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Reported as negative (0, 1+), equivocal (2+), and strongly positive (3+) according to the interpretation guidelines for the FDA-approved Ventana Pathway HER2 (4B5) antibody.
Clinical References Provides recommendations for further in-depth reading of a clinical nature
1. Riber-Hansen R, Vainer B, Steiniche T: Digital image analysis: a review of reproducibility, stability and basic requirements for optimal results. Apmis 2012 April;120(4):276-289
2. Gavrielides MA, Gallas BD, Lenz P, et al: Observer variability in the interpretation of HER2/neu immunohistochemical expression with unaided and computer-aided digital microscopy. Arch Pathol Lab Med Feb;135(2):233-242
3. Cuadros M, Villegas R: Systematic review of HER2 breast cancer testing. Appl Immunohistochem Mol Morphol Jan 2009;17(1):1-7
4. Nassar A, Cohen C, Agersborg SS, et al: Trainable immunohistochemical HER2/neu image analysis: a multisite performance study using 260 breast tissue specimens. Arch Pathol Lab Med 2011 July;135(7):896-902
5. Wolff AC, Hammond ME, Hicks DG, et al: American Society of Clinical Oncology/College of American Pathologists guideline update recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol 2013 Nov 1;31(31):3997-4013