Find Locations
For hours, walk-ins and appointments.HER-2 Immunohistochemistry (IHC), Breast With Reflex to FISH if 2+ by IHC
CPT:
88360. If reflex testing is performed, concomitant CPT codes/charges will apply.
Special Instructions
Please direct any questions regarding this test to oncology customer service at 800-345-4363.
Expected Turnaround Time
4 - 5 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Information
Specimen Requirements
Specimen
Formalin-fixed, paraffin-embedded (FFPE) tumor
Volume
One paraffin block or seven unstained, positively-charged tissue slides cut at 4 to 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 six 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 by immunohistochemistry. Specimens demonstrating 2+ (moderate) staining for the HER-2/neu protein are evaluated for gene amplification status by FISH. In such cases, FISH provides a better indication of potential response to therapy.
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
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 M, 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 KH, 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 |
|---|---|---|---|---|---|---|
| 483289 | HER-2 IHC With Reflex To FISH | 480529 | HER-2/neu (C-erbB-2) | 18474-7 | ||
| 483289 | HER-2 IHC With Reflex To FISH | 480458 | Scoring Guide | 19147-8 | ||
| 483289 | HER-2 IHC With Reflex To FISH | 480382 | Comment | 77202-0 | ||
| 483289 | HER-2 IHC With Reflex To FISH | 480383 | Fixation Time | N/A | ||
| 483289 | HER-2 IHC With Reflex To FISH | 480387 | Fixative | N/A | ||
| 483289 | HER-2 IHC With Reflex To FISH | 480241 | Director Review | 72486-4 |
| Reflex Table for HER-2/neu (C-erbB-2) | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 483297 | HER-2/neu Gene Amplification | 483298 | HER-2/neu Gene Amplification | 31150-6 | |
| Reflex Table for HER-2/neu (C-erbB-2) | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 483297 | HER-2/neu Gene Amplification | 483299 | HER-2/CEP17 Ratio | 49683-6 | |
| Reflex Table for HER-2/neu (C-erbB-2) | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 483297 | HER-2/neu Gene Amplification | 483328 | Avg Num Her-2 signals/nucleus: | 74860-8 | |
| Reflex Table for HER-2/neu (C-erbB-2) | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 483297 | HER-2/neu Gene Amplification | 483329 | Avg Num CEP17 probes/nucleus: | 74861-6 | |
| Reflex Table for HER-2/neu (C-erbB-2) | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 483297 | HER-2/neu Gene Amplification | 483332 | Number of Tumor Cells Counted: | 62361-1 | |
| Reflex Table for HER-2/neu (C-erbB-2) | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 483297 | HER-2/neu Gene Amplification | 483334 | Number of Observers: | N/A | |
| Reflex Table for HER-2/neu (C-erbB-2) | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 483297 | HER-2/neu Gene Amplification | 483336 | Scoring Criteria | 19147-8 | |
| Reflex Table for HER-2/neu (C-erbB-2) | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 483297 | HER-2/neu Gene Amplification | 483003 | Director Review | N/A | |
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