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.
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Test Details


  • c-erb-2


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.


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


Immunohistochemistry (IHC)

Specimen Requirements


Tumor (formalin-fixed, paraffin-embedded)


One paraffin block or 7 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 attach pathology report. Direct any questions regarding this test to oncology customer service at 800-345-4363.


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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