HER-2 Immunohistochemistry (IHC) With Reflex to HERmark® if 2+ by IHC

CPT: 88360. If reflex testing is performed, additional charges/CPT code(s) may apply.
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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% formalin, fixation times less than six hours or greater than 48 hours may not yield reliable results.

Methodology

Immunohistochemistry (IHC)

Specimen Requirements

Specimen

Tumor (formalin-fixed, paraffin-embedded)

Volume

One paraffin block or six 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

Clinical Information

Special Instructions

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

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

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
480845 HER-2 IHC Reflex to HERmark(R) 480527 HER-2/neu (C-ERBB-2) 18474-7
480845 HER-2 IHC Reflex to HERmark(R) 480458 Scoring Guide 19147-8
480845 HER-2 IHC Reflex to HERmark(R) 480404 Comment 77202-0
480845 HER-2 IHC Reflex to HERmark(R) 480405 Fixation Time N/A
480845 HER-2 IHC Reflex to HERmark(R) 480407 Fixative N/A
480845 HER-2 IHC Reflex to HERmark(R) 480234 Director Review 69426-5
480845 HER-2 IHC Reflex to HERmark(R) 482018 Reflex to HERmark(R) N/A
Reflex Table for Reflex to HERmark(R)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 482009 HERmark(R) 482011 HERmark(R) PDF 11526-1
Reflex Table for Reflex to HERmark(R)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 482009 HERmark(R) 482010 HERmark(R) HER2 Status 72383-3
Reflex Table for Reflex to HERmark(R)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 482009 HERmark(R) 482013 HERmark(R) Quantitative Result 72382-5
Reflex Table for Reflex to HERmark(R)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 482009 HERmark(R) 482017 HERmark(R) Ranges 19147-8
Reflex Table for Reflex to HERmark(R)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 482009 HERmark(R) 482015 HERmark(R) Interpretation 77202-0
Reflex Table for Reflex to HERmark(R)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 482009 HERmark(R) 482016 HERmark(R) Methodology 49549-9

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