Find Locations
For hours, walk-ins and appointments.HER-2/CEP17 FISH, Breast With Reflex to Immunohistochemistry (IHC) if Group 2, 3, 4 by FISH
CPT:
88377
Special Instructions
Direct any questions regarding this test to Oncology Customer Service at 800-345-4363.
Specimen Requirements
Specimen
Formalin-fixed, paraffin-embedded (FFPE) tumor
Volume
One paraffin block or seven unstained, positively-charged tissue slides cut at 4-5 microns and dried for one hour at 60°C.
Container
Paraffin block transport pouch or slide mailer
Collection
Specimen should be fixed in 10% neutral-buffered formalin. Fixation time should be between 6 and 72 hours according to ASCO/CAP guidelines; however, the package insert indicates optimum fixation time between 18 and 24 hours.
Storage Instructions
Maintain specimen at room temperature.
Causes for Rejection
Tumor other than breast tumor
Test Details
Use
Tissues are evaluated for gene amplification status by FISH. Specimens demonstrating a classification of Group 2, 3, 4 by FISH are evaluated by immunohistochemistry.
Limitations
Use of fixatives other than 10% neutral-buffered formalin or fixation times less than six hours or more than 48 hours may not yield equivalent or satisfactory results.
Methodology
Fluorescence in situ hybridization (FISH), Immunohistochemistry (IHC)
References
Dybdal N, Lieberman G, Anderson S, et al. Determination of HER2 gene amplification by fluorescence in situ hybridization and concordance with the clinical trials immunohistochemical assay in women with metastatic breast cancer evaluated for treatment With trastuzumab. Breast Cancer Res Treat. 2005 Sep;93(1):3-11.16184453
Mass RD, Press MF, Anderson S, et al. Evaluation of clinical outcomes according to HER2 detection by fluorescence in situ hybridization in women with metastatic breast cancer treated with trastuzumab. Clin Breast Cancer. 2005 Aug;6(3):240- 246.16137435
Wolff AC, Hammond MEH, Allison K, et al. Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. J Clin Oncol. 2018 Jul 10;36(20):2105-2122.29846122
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 483333 | HER-2/CEP17 REFLEX IHC | 483249 | HER-2/neu FISH | 31150-6 | ||
| 483333 | HER-2/CEP17 REFLEX IHC | 483299 | HER-2/CEP17 Ratio | 49683-6 | ||
| 483333 | HER-2/CEP17 REFLEX IHC | 483328 | Avg Num Her-2 signals/nucleus: | 74860-8 | ||
| 483333 | HER-2/CEP17 REFLEX IHC | 483329 | Avg Num CEP17 probes/nucleus: | 74861-6 | ||
| 483333 | HER-2/CEP17 REFLEX IHC | 483332 | Number of Tumor Cells Counted: | 62361-1 | ||
| 483333 | HER-2/CEP17 REFLEX IHC | 483334 | Number of Observers: | N/A | ||
| 483333 | HER-2/CEP17 REFLEX IHC | 483259 | Fixation Time | N/A | ||
| 483333 | HER-2/CEP17 REFLEX IHC | 483260 | Fixative | N/A | ||
| 483333 | HER-2/CEP17 REFLEX IHC | 483336 | Scoring Criteria | 19147-8 | ||
| 483333 | HER-2/CEP17 REFLEX IHC | 483363 | Director Review | 59465-5 | ||
| 483333 | HER-2/CEP17 REFLEX IHC | 483304 | Reflex | N/A |
| Reflex Table for Reflex | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 483303 | HER-2/neu Oncoprot, Paraffin | 480441 | HER-2/neu (C-erbB-2) | 18474-7 | |
| Reflex Table for Reflex | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 483303 | HER-2/neu Oncoprot, Paraffin | 480458 | Scoring Guide | 19147-8 | |
| Reflex Table for Reflex | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 483303 | HER-2/neu Oncoprot, Paraffin | 480381 | Comment | 77202-0 | |
| Reflex Table for Reflex | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 483303 | HER-2/neu Oncoprot, Paraffin | 483256 | Fixation Time | N/A | |
| Reflex Table for Reflex | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 483303 | HER-2/neu Oncoprot, Paraffin | 483257 | Fixative | N/A | |
| Reflex Table for Reflex | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 483303 | HER-2/neu Oncoprot, Paraffin | 480233 | Director Review | 69426-5 | |
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