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
A pathology report is required for testing to be performed. It should include patient name, block number, date of collection, tissue source, fixation method and time in fixation (recommended: >6 hours and <72 hours). The specimen must not be derived from primary or metastatic gastroesophageal carcinoma; if so, the test will be canceled and automatically reordered as H2GE. This test does not include a pathology consult. Optimum fixation should be between 6 and 72 hours in 10% neutral buffered formalin. Specimens should be placed in fixative within one hour of biopsy or resection.
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
LOINC Codes
- 96893-3
- 50397-9
- 69965-2
- 62356-1
- 42349-1
- 31208-2
- 85303-6
- 80398-1
- 8100-0
- 85069-3
- 48767-8
- 62364-5
- 18771-6
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.