Test Code H2GE HER2 Amplification Associated with Gastroesophageal Cancer, FISH, Tissue
Ordering Guidance
This test is only performed on specimens from patients with primary or metastatic gastroesophageal tumors.
This test is not appropriate if the specimen is derived from primary or metastatic breast carcinoma. See H2BR / HER2 Amplification Associated with Breast Cancer, FISH, Tissue. If this test is ordered and the laboratory is informed that the specimen is a primary or metastatic breast carcinoma, it will be canceled and automatically reordered by the laboratory as H2BR.
For all other tumor types, order H2MT / HER2 Amplification, Miscellaneous Tumor, FISH, Tissue. If this test is ordered and the laboratory is informed that the specimen is a primary or metastatic colorectal adenocarcinoma, endometrial serous carcinoma, urothelial carcinoma, or any other non-breast or non-gastroesophageal primary or metastatic tumor, it will be canceled and automatically reordered by the laboratory as H2MT.
This test does not include a pathology consult. If a pathology consultation is requested, order PATHC / Pathology Consultation, and the appropriate testing will be added at the discretion of the pathologist and performed at an additional charge.
Shipping Instructions
Advise Express Mail or equivalent if not on courier service.
Necessary Information
1. A pathology report is required for testing to be performed. If not provided, appropriate testing and/or interpretation may be compromised or delayed. Acceptable pathology reports include working drafts, preliminary pathology, or surgical pathology reports.
2. The following information must be included in the report provided:
-Patient name
-Block number - must be on all blocks, slides, and paperwork
-Date of collection
-Tissue source
-Fixation used AND time in fixation (recommended: >6 hours and <72 hours).
3. A reason for testing must be provided. If this information is not provided, an appropriate indication for testing may be entered by Mayo Clinic Laboratories.
Specimen Required
Submit only 1 of the following specimens:
Preferred
Specimen Type: 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.
Acceptable
Specimen Type: Tissue slides
Slides: 1 Hematoxylin and eosin stained and 4 unstained
Collection Instructions: Submit 1 slide stained with hematoxylin and eosin and 4 consecutive, unstained, positively charged, unbaked slides with 5-micron-thick sections of the tumor tissue. Slides cut from blocks prepared with alternative fixation methods may be acceptable; provide fixation method used.
Useful For
A predictive marker for patients with both node-positive or node-negative primary and metastatic gastroesophageal cancer
Guiding therapy for patients with primary or metastatic gastroesophageal tumors, as patients with HER2 amplification may be candidates for therapies that target the human epidermal growth factor receptor 2 (HER2) protein (eg, trastuzumab [Herceptin], pertuzumab)
Confirming the presence or absence of HER2 amplification in cases with 2+ (equivocal) HER2 overexpression by immunohistochemistry
Method Name
Fluorescence In Situ Hybridization (FISH)
Reporting Name
HER2, Gastroesophageal FISH, TissueSpecimen Type
TissueSpecimen Minimum Volume
Slides: 1 Hematoxylin and eosin-stained and 2 unstained
Specimen Stability Information
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Tissue | Ambient (preferred) | ||
Refrigerated |
Reject Due To
All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.Clinical Information
Gastroesophageal cancer is one of the most diagnosed cancers. To date, chemotherapy for gastroesophageal cancer is often ineffective, and its prognosis remains poor. Recent studies suggest that the HER2 oncogene can be used as a marker to identify aggressive disease.
In much the same way as was demonstrated for HER2-positive breast cancer, the HER2 gene status in gastroesophageal cancers can be used to determine treatment approaches. Amplification of the HER2 gene and overexpression of the human epidermal growth factor receptor 2 (HER2) protein have been associated with a shorter disease-free survival and shorter overall survival in gastric and gastroesophageal junction cancers. Patients whose tumors demonstrate HER2 amplification or overexpression may be candidates for treatment with the drugs that target the HER2 protein or its downstream pathways (eg, trastuzumab [Herceptin], pertuzumab).
Reference Values
An interpretative report will be provided.
Day(s) Performed
Monday through Friday
Report Available
6 to 8 daysPerforming Laboratory
Mayo Clinic Laboratories in RochesterTest Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
88377
Forms
If not ordering electronically, complete, print, and send a Oncology Test Request (T729) with the specimen.