HER-2/neu IHC, Breast Paraffin

CPT: 88360
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Synonyms

  • c-erb-2

Special Instructions

Fixation time and fixative used must be indicated on the test request form. Please direct any questions regarding this test to oncology customer service at 800-345-4363.


Expected Turnaround Time

5 - 9 days



Specimen Requirements


Specimen

Formalin-fixed, paraffin-embedded (FFPE) tumor


Volume

One paraffin block or five 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

The HER-2/neu protein is a product of the HER-2/neu oncogene, and the detection of overexpression of the HER-2/neu protein has been associated in clinical evaluations with a decreased survival time and a decreased time to relapse in patients with breast cancer.1-3 HER-2/neu overexpression is also a predictor of response to certain breast cancer therapies, including targeted immunotherapies.4-6


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 reliable results.


Methodology

Immunohistochemistry (IHC)


Footnotes

1. Press MF, Pike MC, Chazin VR, et al. HER-2/neu expression in node-negative breast cancer: Direct tissue quantitation by computerized image analysis and association of overexpression with increased risk of recurrent disease. Cancer Res. 1993 Oct 15; 53(20):4960-4970. 8104689
2. Paik S, Hazan R, Fisher ER, et al. Pathologic findings from the National Surgical Adjuvant Breast and Bowel Project: Prognostic significance of erbB-2 protein overexpression in primary breast cancer. J Clin Oncol. 1990 Jan; 8(1):103-112. 1967301
3. Tandon AK, Clark GM, Chamness GC, Ullrich A, McGuire WL. HER-2/neu oncogene protein and prognosis in breast cancer. J Clin Oncol. 1989 Aug; 7(8):1120-1128. 2569032
4. Muss HB, Thor AD, Berry DA, et al. c-erbB-2 expression and response to adjuvant therapy in women with node-positive early breast cancer. N Engl J Med. 1994 May 5; 330(18):1260-1266. 7908410
5. Khoo US, Leong ASY. Biologic markers in breast cancer: An update. J Histotechnology. 1998; 21(4):317-325.
6. Fitzgibbons PL, Page DL, Weaver D, et al. Prognostic factors in breast cancer. College of American Pathologists Consensus Statement 1999. Arch Pathol Lab Med. 2000 Jul; 124(7):966-978. 10888772

References

Modi S, Jacot W, Yamashita T, et al. Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer. N Engl J Med. 2022 Jul 7;387(1):9-20.3566578
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody [package insert]. Roche Diagnostics; Sep. 29, 2022.
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
480376 HER-2/neu Oncoprot, Paraffin 480449 HER-2/neu (C-erbB-2) 18474-7
480376 HER-2/neu Oncoprot, Paraffin 480458 Scoring Guide 19147-8
480376 HER-2/neu Oncoprot, Paraffin 480381 Comment 77202-0
480376 HER-2/neu Oncoprot, Paraffin 483256 Fixation Time N/A
480376 HER-2/neu Oncoprot, Paraffin 483257 Fixative N/A
480376 HER-2/neu Oncoprot, Paraffin 480233 Director Review 69426-5

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