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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.
This FDA-approved test is most frequently used to evaluate HER2 overexpression in breast cancer.
Determining overexpression of HER2 protein on formalin-fixed, paraffin-embedded tissue sections
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).
The performance and quality of immunohistochemical stains in formalin-fixed, paraffin-embedded tissue is critically dependent on proper fixation.
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.
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