Find Locations
For hours, walk-ins and appointments.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
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 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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