HER-2 Immunohistochemistry (IHC), Breast With Reflex to FISH if 0, 1+, or 2+ by IHC

CPT: 88360. If reflex testing is performed, concomitant CPT codes/charges will apply.
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Test Details

Synonyms

  • c-erb-2
  • IHC

Use

Tissues are evaluated by immunohistochemistry. Specimens demonstrating 0, 1+ (mild) or 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. (See also reflex testing for IHC results of 2+ [483289].)

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)

Specimen Requirements

Specimen

Tumor (formalin-fixed, paraffin-embedded)

Volume

One paraffin block

Container

Paraffin block transport pouch

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

Clinical Information

Special Instructions

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

Note: Per client request, the IHC will reflex to FISH if the result is 0, 1+ or 2+.

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 ME, Hicks DG, et al. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update.J Clin Oncol. 2013 Nov 1; 31(31): 3997-4013. 24101045

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
483320 HER-2 IHC With Reflex To FISH 480527 HER-2/neu (C-ERBB-2) 18474-7
483320 HER-2 IHC With Reflex To FISH 480458 Scoring Guide 19147-8
483320 HER-2 IHC With Reflex To FISH 480404 Comment 77202-0
483320 HER-2 IHC With Reflex To FISH 480405 Fixation Time N/A
483320 HER-2 IHC With Reflex To FISH 480407 Fixative N/A
483320 HER-2 IHC With Reflex To FISH 480234 Director Review 69426-5
483320 HER-2 IHC With Reflex To FISH 483322 Reflex N/A
Reflex Table for Reflex
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 Reflex
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 Reflex
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 Reflex
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 Reflex
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 Reflex
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 Reflex
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 Reflex
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 483297 HER-2/neu Gene Amplification 483003 Directior Review N/A

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