HER2 by Immunohistochemistry
Test Code
I HER2 or I HER2 TC
Test Synonyms
PATHWAY (4B5), Immuno, Immunohistochemistry, Immunoperoxidase
Associations
Breast cancer, Herceptin
Methodology
Immunohistochemistry
CPT Codes
88360 – Morphometric analysis, tumor immunohistochemstry
Turnaround Time
3 days
Specimen Requirements
Formalin fixed paraffin embedded tissue block
Specimen Stability
Indefinitely
Storage & Handling
Ship blocks at ambient temperature.
Causes for Rejection
Improper specimen labeling; Insufficient sample; Inadequate fixation and/or processing
Reference Range
Normal breast tissues may produce positive reactivity scoring 1+ intensity, as will kidney, uterus and epithelium of the colon, stomach and small intestine. Normal tissues producing 2+ to 3+ staining intensity include esophageal epithelia, Langerhans cells, pituitary endocrine cells, prostate and squamous epithelia of tonsil.
Related Content
Click here for Ventana Interpretive Guide
Ventana Medical Systems, Inc.'s (Ventana) PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PATHWAY HER2(4B5))is a rabbit monoclonal antibody intended for laboratory use for the semi-quantitative detection of HER2 antigen in sections of formalin-fixed, paraffin-embedded normal and neoplastic tissue on a Ventana automated immunohistochemistry slide staining device. It is indicated as an aid in the assessment of breast cancer patients for whom Herceptin® treatment is considered.
Ventana Medical Systems, Inc.'s (Ventana) PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PATHWAY HER2(4B5))is a rabbit monoclonal antibody intended for laboratory use for the semi-quantitative detection of HER2 antigen in sections of formalin-fixed, paraffin-embedded normal and neoplastic tissue on a Ventana automated immunohistochemistry slide staining device. It is indicated as an aid in the assessment of breast cancer patients for whom Herceptin® treatment is considered.
Description
In a fraction of patients with breast cancer, the HER2 protein is over expressed as part of the process of malignant transformation and tumor progression. Over expression of the HER2 protein on the surface of breast cancer cells suggest that it could be a target for antibody therapy, Herceptin (Trastuzumab).
References
- Coussens L et al. (1985). Tyrosine kinase receptor with extensive homology to EGF receptor shares chromosomal location with neu oncogene. Science. 230:1132-9.
- King CR, Kraus MH, Aaronson SA. (1985). Amplification of a novel v-erbB-related gene in a human mammary carcinoma. Science. 229:974-6.
Trademarks
HercepTest is a registered trademark of Genentech, Inc.