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HelpTest 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, TissueSpecimen Type
TissueSpecimen 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 daysPerforming 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.