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HelpTest 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, 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
In much the same way as was demonstrated for HER2-positive breast cancer, the HER2 gene status in some 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 some 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.
Interpretation
An interpretive report will be provided.
Results for tumors of colorectal origin are interpreted with reference to the definition of HER2 amplification in colorectal cancer in the HERACLES trial, a HER2 / centromere ratio 2.0 or above is considered positive(2) as well as with reference to the MyPathway trial, a HER2 / centromere ratio above 2.0 or average HER2 copy number above 6.0 is considered positive.(3)
Results for primary or metastatic endometrial serous carcinomas are interpreted according to expert recommendations(4) and according to updated American Society of Clinical Oncology/College of American Pathologists (ASCP/CAP) (2018) guidelines for breast cancer.(5)
All other tumors are interpreted as amplified if HER2 / centromere ratio is greater than or equal to 2.0 or average HER2 copy number greater than or equal to 6.0 and according to according to updated ASCO/CAP (2013) guidelines for breast cancer.(1)
The degree of HER2 amplification varies in tumors. Some exhibit a high level of amplification (HER2:D17Z1 ratio >4.0), whereas others exhibit low-level amplification (HER2:D17Z1 ratio of 2.0-4.0). It is not currently known if patients with different levels of amplification have a similar prognosis or response to therapy.
Rare cases may not show HER2 amplification but have human epidermal growth factor receptor 2 (HER2) protein overexpression demonstrated by immunohistochemistry. The clinical significance of HER2 protein overexpression in the absence of HER2 gene amplification is unclear. However, these patients may have a worse prognosis and may be candidates for treatments that target the HER2 protein or its downstream pathways.
Cautions
Optimum fixation should be between 6 and 72 hours in 10% neutral buffered formalin. Other fixation methods should not be used, but the specimen will not be rejected.
Paraffin-embedded tissues that have been decalcified may not be successful for fluorescence in situ hybridization (FISH) analysis. The success rate of FISH studies on decalcified tissue is approximately 50%, but FISH will be attempted if sufficient tumor is present for analysis.
This test is not approved by the US Food and Drug Administration, and it is best used as an adjunct to existing clinical and pathologic information.
The prognostic information provided by the HER2 status of a patient's tumor should not be interpreted in isolation because other prognostic features (eg, lymph node status, tumor size) may be of equal or greater importance in determining the patient's prognosis.
Method Description
The test is performed using the dual-color PathVysion HER2 DNA probe set (Abbott Molecular) with a HER2 probe and a chromosome 17 centromere probe (CEP17; D17Z1). Paraffin-embedded tissues are cut at 5 microns and mounted on positively charged glass slides. The selection of tissue and the identification of target areas on the hematoxylin and eosin (H and E)-stained slide are performed by a pathologist. Using the H and E-stained slide as a reference, target areas are etched with a diamond-tipped engraving tool on the back of the unstained slide to be assayed. The probe is hybridized to the appropriate target areas, and 2 technologists each analyze 30 interphase nuclei (60 total) with the results expressed as a ratio of HER2:D17Z1 signals.(Unpublished Mayo method)
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. 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 |