HER-2/neu IHC, Breast Paraffin

CPT: 88360
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Test Details


  • c-erb-2


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


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.


Immunohistochemistry (IHC)

Specimen Requirements


Formalin-fixed, paraffin-embedded (FFPE) tumor


One paraffin block or five unstained, positively-charged tissue slides cut at 4 to 5 microns and dried for one hour at 60°C


Paraffin block transport pouch or slide mailer


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

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.


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


Wolff AC, Hammond ME, Hicks DG, et al. Recommendations for HER2 testing in breast cancer: ASCP/CAP clinical practice guideline update. J Clin Oncol. 2013 Nov 1; 31(31):3997-4013.17159189


Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
480376 HER-2/neu Oncoprot, Paraffin 480233 Director Review 69426-5
480376 HER-2/neu Oncoprot, Paraffin 480381 Comment 77202-0
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 483256 Fixation Time N/A
480376 HER-2/neu Oncoprot, Paraffin 483257 Fixative N/A

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