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26080 HER2 Amp, Misc Tumor, FISH, Tissue (H2MT)

HER2 Amp, Misc Tumor, FISH, Tissue (H2MT)
Test Code: H2MTFSO
Synonyms/Keywords

​c-erb-b2 Amplification Test

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
Specimen Requirements
Fasting Required Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
​No ​Tissue ​Tissue Block
​No ​Slides ​4un, 1 H&E ​2un, 1 H&E
Collection Processing Instructions

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

OR

Four consecutive, unstained, 5 micron-thick sections placed on positively charged slides, and 1 hematoxylin and eosin-stained slide.
 
Necessary Information:
1. A pathology report is required in order for testing to be performed.
2. A reason for testing must be provided.
3. The pathology report must include type of fixation used as well as the time of fixation.
Specimen Stability Information
Specimen Type Temperature
​Tissue ​Ambient/Refrigerate
Interference

​This test is not approved by the FDA and should be 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.

Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Mayo Clinic Laboratories ​Monday through Friday ​6-8 days ​Fluorescence In Situ Hybridization (FISH)
Reference Lab
Test Information

​Amplification of the HER2 oncogene 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 and poorer overall survival in some cancers. Patients whose breast or gastroesophageal cancers 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, lapatinib).

Reference Range Information
See Report
Interpretation

​An interpretive report will be provided. Results are interpreted utilizing the 2013 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines for breast tumors.

Specimens with equivocal (Group 4) results as defined by 2013 ASCO/CAP guidelines will not have reflex testing performed using an alternative FISH probe set. The report will include a complete interpretation including the HER2:D17Z1 results.

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.

Reports also interpret the HER2 copy number changes relative to chromosome 17 copy number (aneusomy) or potential structural genomic abnormalities that increase HER2 copy number.

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.

Outreach CPTs
CPT Modifier
(if needed)
Quantity Description Comments
88377 1 Each multiplex probe stain procedure

 

Synonyms/Keywords

​c-erb-b2 Amplification Test

Ordering Applications
Ordering Application Description
​Centricity ​HER2 Amp, Misc Tumor, FISH, Tissue (H2MTF)
​Cerner ​HER2 Amp, Misc Tumor, FISH, Tissue (H2MTF)
​COM ​HER2 Amp, Misc Tumor, FISH, Tissue (H2MTF)
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Fasting Required Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
​No ​Tissue ​Tissue Block
​No ​Slides ​4un, 1 H&E ​2un, 1 H&E
Collection Processing

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

OR

Four consecutive, unstained, 5 micron-thick sections placed on positively charged slides, and 1 hematoxylin and eosin-stained slide.
 
Necessary Information:
1. A pathology report is required in order for testing to be performed.
2. A reason for testing must be provided.
3. The pathology report must include type of fixation used as well as the time of fixation.
Specimen Stability Information
Specimen Type Temperature
​Tissue ​Ambient/Refrigerate
Interference

​This test is not approved by the FDA and should be 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.

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
Reference Range Information
See Report
Interpretation

​An interpretive report will be provided. Results are interpreted utilizing the 2013 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines for breast tumors.

Specimens with equivocal (Group 4) results as defined by 2013 ASCO/CAP guidelines will not have reflex testing performed using an alternative FISH probe set. The report will include a complete interpretation including the HER2:D17Z1 results.

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.

Reports also interpret the HER2 copy number changes relative to chromosome 17 copy number (aneusomy) or potential structural genomic abnormalities that increase HER2 copy number.

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.

For more information visit:
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Mayo Clinic Laboratories ​Monday through Friday ​6-8 days ​Fluorescence In Situ Hybridization (FISH)
Reference Lab
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)
Quantity Description Comments
88377 1 Each multiplex probe stain procedure

 

For most current information refer to the Marshfield Laboratory online reference manual.