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Test Code H2MT HER2 Amplification, Miscellaneous Tumor, FISH, Tissue


Ordering Guidance


This test is only performed on specimens from patients with primary or metastatic tumors other than breast or gastroesophageal.

 

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.

 

This test is not appropriate if the specimen is derived from primary or metastatic gastroesophageal carcinoma. See H2GE / HER2 Amplification Associated with Gastroesophageal Cancer, FISH, Tissue. If this test is ordered and the laboratory is informed that the specimen is a primary or metastatic gastroesophageal carcinoma, it will be canceled and automatically reordered by the laboratory as H2GE.

 

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

Guiding cancer therapy, 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 of HER2 amplification in cases with 2+ (low level) or 3+ (high level) HER2 protein overexpression by immunohistochemistry

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)

Reporting Name

HER2, Misc. Tumor, FISH, Tissue

Specimen Type

Tissue

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 

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

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test 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

LOINC Code Information

Test ID Test Order Name Order LOINC Value
H2MT HER2, Misc. Tumor, FISH, Tissue 96893-3

 

Result ID Test Result Name Result LOINC Value
603096 Result Summary 50397-9
603097 Interpretation 69965-2
603098 Result 62356-1
GC032 Reason for Referral 42349-1
603099 Specimen 31208-2
603100 Source 85298-8
603101 Tissue ID 80398-1
603102 Fixative 8100-0
603103 Method 85069-3
603104 Additional Information 48767-8
603105 Disclaimer 62364-5
603106 Released By 18771-6

NY State Approved

Yes

Forms

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