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.
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Special Instructions

Please direct any questions regarding this test to oncology customer service at 800-345-4363.


Expected Turnaround Time

4 - 5 days


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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