FISH for HER-2
Test Mnemonic
HER2F
CPT Codes
- 88377 - QTY (1)
Aliases
- Breast Cancer (HER2/ERBB2) Gene Amplification
- FISH for HER2 (ERBB2)
Includes
- LSI 17p11
Performing Laboratory
Cleveland Clinic Laboratories
Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 2 slides | Slide (s), unstained | Clean container | N/A | Ambient | One formalin-fixed, paraffin embedded block containing representative tissue OR unstained 4 μm tissue sections on electrostatically charged slides containing representative tumor. Tissue must be fixed in formalin NOT B5 or PREFER fixative IHC data must be included when ordering HER2 FISH testing. |
Stability
| Environmental Condition | Description |
|---|---|
| Ambient | Sample is formalin fixed and must not be fixed in Prefer or B5 |
Days Performed
5 days per week
Turnaround Time
5 - 7 days
Methodology
| Name | Description |
|---|---|
| Fluorescent In-Situ Hybridization (FISH) |
Reference Range
Special Info
Breast cancer tissue: primary or metastatic. IHC data must be included when ordering HER2 FISH testing. Please note: based on the 2018 Focused Update to the ASCO/CAP guidelines for human epidermal growth factor receptor 2 testing in breast cancer (PMID:29846104), reflex testing using immunohistochemistry will be performed when the HER2 (ERBB2) FISH result is Group 2, 3, or 4. For these cases, the TAT will be extended by 3-4 days.
Clinical Info
Interphase FISH analysis utilizing an enumeration probe for the ERBB2 (HER2) gene at 17q12, as well as a probe specific to the centromere of chromosome 17. Used to detect amplification of the ERBB2 (HER2) gene in human breast tissue specimens, and other tumors, both primary and metastatic. If no cells are available for analysis, no analysis charges will be incurred.
Clinical Limitation
This assay has not been validated n decalcified tissues. Results should be interpreted with caution given the likelihood of false negativity on decalcified specimens. This assay is not validated for primary gastric tumors.