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TEST ID H2GE HER2 Amplification Associated with Gastroesophageal Cancer, FISH, Tissue

Reporting Name

HER2, Gastroesophageal FISH, Tissue

Specimen Type

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.


Specimen Minimum Volume

Slides: 1 Hematoxylin and eosin-stained and 2 unstained

Specimen Stability Information

Specimen Type Temperature Time Special Container
Tissue Ambient (preferred)
  Refrigerated 

Testing Algorithm

This test includes a charge for the probe application, analysis, and professional interpretation of results for one probe set (2 individual fluorescence in situ hybridization [FISH] probes). No analysis charges will be incurred if an insufficient number of representative cells are available for analysis.

 

Note: In accordance with criteria outlined in the 2013 American Society of Clinical Oncology/College of American Pathologists guideline for breast cancer, reflex testing will not be performed using an alternative chromosome 17 probe when the FISH result is equivocal.(1)

 

Appropriate ancillary probes may be performed at consultant discretion to render comprehensive assessment. Any additional probes will have the results included within the final report and will be performed at an additional charge.

Method Name

Fluorescence In Situ Hybridization (FISH)

Reject Due To

All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Reference Values

An interpretative report will be provided.

Day(s) Performed

Monday through Friday

Report Available

6 to 8 days

Specimen Retention Time

Slides and H and E used for analysis are retained by the laboratory in accordance with regulatory requirements. Client provided paraffin blocks and extra unstained slides will be returned after testing is complete.

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

88377

Forms

If not ordering electronically, complete, print, and send a Oncology Test Request (T729) with the specimen.

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