HER2, Breast, Semi-Quantitative Immunohistochemistry, Manual with HER2 FISH Reflex
Use
The HER2 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 (trastuzumab) therapy in patients with breast cancer. This test is most frequently used to evaluate HER2 overexpression in breast cancer.
Special Instructions
An accompanying pathology report stating the final diagnosis is required. Information regarding fixative used, time to fixation, and duration of fixation as well as tumor type and classification is required. For gastroesophageal cancer, consider alternative specific tests. Paraffin blocks will be returned with the final report.
Limitations
HER2 protein immunohistochemical test results are only valid for nondecalcified, paraffin-embedded specimens fixed in 10% neutral buffered formalin within 1 hour from surgical collection time and for a total time of 6 to 72 hours. Delay to fixation, or under- or over-fixation may affect these results. HER2 immunohistochemistry testing on intracystic papillary carcinoma and solid papillary carcinoma, without clearly stating invasive carcinoma, is not appropriate and will be reported as indeterminate.
New York Approved
Methodology
Immunoassay (IHC)
Biomarkers
LOINC Codes
- 85319-2
- 50595-8
- 19139-5
- 81178-6
- 8100-0
- 44638-5
- 21918-8
- 62364-5
- 80398-1
Result Turnaround Time
5-15 days
Related Documents
For more information, please review the documents below
Specimen
Tumor Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Container
Pathology Packaging Kit
Collection Instructions
Submit paraffin-embedded invasive or metastatic breast carcinoma tissue.
Causes for Rejection
No specimen should be rejected.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Ambient (preferred) |