HER2 Amplification, Miscellaneous Tumor, FISH, Tissue
Use
This test is useful for guiding cancer therapy, as patients with HER2 amplification may be candidates for therapies that target the human epidermal growth factor receptor 2 (HER2) protein, such as trastuzumab (Herceptin) and pertuzumab. It is also valuable for confirming the presence of HER2 amplification in cases with 2+ (low level) or 3+ (high level) HER2 protein overexpression determined by immunohistochemistry. Amplification of the HER2 gene has been associated with shorter disease-free survival and overall survival in some cancers, making it a key marker for treatment planning.
Special Instructions
This test is performed on specimens from patients with primary or metastatic tumors other than breast or gastroesophageal cancer. It cannot be used if the specimen is derived from primary or metastatic breast or gastroesophageal carcinoma; in such cases, appropriate alternative tests will be reordered automatically. A pathology report must be provided for testing to be performed, with details such as tissue source and fixation method included.
Limitations
The test is not FDA-approved and should be used as an adjunct to clinical and pathologic information. Optimal fixation is required, and decalcified tissues may have a reduced success rate in analysis. HER2 status alone should not be used in isolation for prognosis, as other anatomical and clinical factors are also important. Rare cases without HER2 amplification but with protein overexpression may have unclear clinical significance but could still benefit from targeted therapies.
New York Approved
Methodology
Chromosomal / Cytogenetics (FISH)
Biomarkers
LOINC Codes
- 96893-3
- 50397-9
- 69965-2
- 62356-1
- 42349-1
- 31208-2
- 85298-8
- 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
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.
Causes for Rejection
All specimens will be evaluated for test suitability.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Ambient (preferred) |