HER2 Amplification Associated with Gastroesophageal Cancer, FISH, Tissue
Use
This test serves as a predictive marker for patients with both node-positive and node-negative primary and metastatic gastroesophageal cancer. It helps in guiding therapy for patients with gastroesophageal tumors, as those with HER2 amplification may be candidates for therapies targeting the HER2 protein, such as trastuzumab or pertuzumab. The test also confirms the presence or absence of HER2 amplification in cases with 2+ (equivocal) HER2 overexpression by immunohistochemistry.
Special Instructions
Not provided.
Limitations
The test is not approved by the US Food and Drug Administration and is best used as an adjunct to existing clinical and pathological information. Optimum fixation should be between 6 and 72 hours in 10% neutral buffered formalin. Paraffin-embedded tissues that have been decalcified may have a lower success rate for FISH analysis. Prognostic information provided by HER2 status should not be interpreted independently, as other factors may be significant.
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
- 85298-8 - Struct incl in spec 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 tumor 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.