HER2 Amplification Associated with Breast Cancer, FISH, Tissue
Use
This test is a predictive marker for patients with both node-positive or node-negative primary and metastatic breast cancer. It is used to identify patients with HER2 amplification, who may be candidates for therapies targeting the human epidermal growth factor receptor 2 (HER2) protein, such as trastuzumab (Herceptin), pertuzumab, and lapatinib. Additionally, this test confirms the presence of HER2 amplification in cases with low level (2+) or high level (3+) HER2 overexpression by immunohistochemistry, as well as in certain histologic subtypes with aberrant HER2 expression patterns.
Special Instructions
Not provided.
Limitations
The test is not approved by the US FDA and is used as an adjunct to clinical and pathological information. It is not appropriate for specimens from primary or metastatic gastroesophageal carcinoma. The prognostic information from HER2 status should not be interpreted alone, as other prognostic features (e.g., lymph node status, tumor size, hormone receptor status) may be equally or more important in determining prognosis. Parsely decalcified tissues or prolonged fixation may yield suboptimal results. The prognostic significance of HER2 protein overexpression without gene amplification is unclear, but such patients may still have a worse prognosis.
New York Approved
Methodology
Chromosomal / Cytogenetics (FISH)
Biomarkers
No genes
Gene
LOINC Codes
- 96893-3 - ERBB2 gene Dp Tumor FISH
- 50397-9 - Mol dx interp Bld/T Ql
- 69965-2 - Clinical cytogeneticist review
- 62356-1 - Chrom analy result (ISCN)
- 42349-1
- 31208-2 - Specimen source
- 85303-6 - Struct of origin Br ca spec
- 80398-1 - Unique ID Current sample
- 8100-0 - Specimen preparation
- 85069-3 - Lab test method
- 48767-8 - Annotation comment Imp
- 62364-5 - Test performance info Spec
- 18771-6 - Provider signing name
Result Turnaround Time
6-8 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Container
Formalin-fixed, paraffin-embedded tissue block
Collection Instructions
Submit a formalin-fixed, paraffin-embedded tumor tissue block. Blocks prepared with alternative fixation methods may be acceptable; provide fixation method used.
Storage Instructions
Ambient (preferred) or refrigerated.
Causes for Rejection
Specimens that do not meet the required criteria for fixation and preparation may be rejected.