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


Ordering Guidance


This test is only for primary or metastatic tumors other than breast, urothelial, or gastroesophageal.

-For breast tumors, order H2BR / HER2 Amplification Associated with Breast Cancer, FISH, Tissue.

-For urothelial tumors, order H2UR / HER2 Amplification Associated with Urothelial Carcinoma, FISH, Tissue.

-For gastroesophageal tumors, order H2GE / HER2 Amplification Associated with Gastroesophageal Cancer, FISH, Tissue.



Shipping Instructions


Advise Express Mail or equivalent if not on courier service.



Necessary Information


1. A pathology report is required in order for testing to be performed. Acceptable pathology reports include working drafts, preliminary pathology or surgical pathology reports.

2. 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.

3. The pathology report must include type of fixation used as well as the time of fixation (recommended: >6 hours and <72 hours).



Specimen Required


Submit only 1 of the following specimens:

 

Specimen Type: Tissue

Preferred: Tissue block

Collection Instructions: Submit a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block. Blocks prepared with alternative fixation methods may be acceptable; provide fixation method used.

 

Acceptable: Slides

Collection Instructions: Four consecutive, unstained, 5 micron-thick sections placed on positively charged slides, and 1 hematoxylin and eosin-stained slide.


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 does not include a pathology consult. If a pathology consult is requested, PATHC / Pathology Consultation should be ordered and the appropriate FISH test will be ordered and performed at an additional charge.

 

A charge and CPT code is applied for each probe set hybridized, analyzed, and reported.

 

NOTE: in accordance to criteria set forth in the 2013 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline for breast cancer, reflex testing will not be performed using the alternative chromosome 17 probe when the FISH result is equivocal.

Method Name

Fluorescence In Situ Hybridization (FISH)

Reporting Name

HER2, Misc. Tumor, FISH, Tissue

Specimen Type

Tissue

Specimen Minimum Volume

Two consecutive, unstained, 5-micron-thick sections placed on positively charged slides and 1 hematoxylin and eosin slide.

Specimen Stability Information

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

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. This test 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

Forms

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