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

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

Use

Tissues are evaluated by immunohistochemistry. Specimens demonstrating 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 0, 1+, or 2+ [483320].)

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

Formalin-fixed, paraffin-embedded (FFPE) tumor

Volume

One paraffin block or seven 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 direct any questions regarding this test to oncology customer service at 800-345-4363.

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

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The LOINC® codes are copyright © 1994-2018, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf