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

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

Test Details

Synonyms

  • c-erb-2

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.

Limitations

Use of fixatives other than 10% formalin may not yield equivalent or satisfactory results.

Methodology

Immunohistochemistry (IHC)

Specimen Requirements

Specimen

Tumor (formalin-fixed, paraffin-embedded)

Volume

One paraffin block or 7 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

Fixation time and fixative used must be indicated on the test request form.

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

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

For Providers

Please login to order a test.

 

© 2018  Laboratory Corporation of America® Holdings and Lexi-Comp Inc. All Rights Reserved.

CPT Statement/Profile Statement

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