HER-2/CEP17, FISH With Reflex to HERmark® if FISH Equivocal

CPT: 88377. If reflex testing is performed, concomitant CPT codes/charges will apply.
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Test Details


  • HERmark® Reflex


Qualitative determination of HER-2/neu gene amplification; prognostic information regarding risk of recurrence and disease-related death; predict response to therapies, including targeted immunotherapies


Use of fixatives other than 10% formalin, fixation times less than 6 hours or greater than 48 hours may not yield reliable results.

Results of the HER-2/neu FISH assay should always be used in conjunction with other information available from the clinical evaluation of the patient and other prognostic factors, such as tumor size, histologic grade, nodal status, patient's age, hormone receptor status, and other known risk factors.


Fluorescence in situ hybridization (FISH)

Specimen Requirements


Tumor (formalin-fixed, paraffin-embedded)


One paraffin block or eight unstained, positively charged tissue slides cut at 4 to 5 microns and dried overnight at 56°C.


Paraffin block transport pouch or slide mailer.


Specimen should be fixed in 10% neutral-buffered formalin. Fixation time should be between 6 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

Fixative other than neutral-buffered formalin; quantity not sufficient for analysis; 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.


Mass RD, Press M, Anderson S, et al. Improved survival benefit from Herceptin in patients selected by fluorescence in situ hybridization (FISH). American Society of Clinical Oncology, Annual Meeting, 2001.
Press MF, Bernstein L, Thomas PA, et al. HER-2/neu gene amplification characterized by fluorescence in situ hybridization: Poor prognosis in node-negative breast carcinomas. J Clin Oncol. 1997 Aug; 15(8):2894-2904. 9256133
Seshadri R, Firgaira FA, Horsfall DJ, McCaul K, Setlur V, Kitchen P. Clinical significance of HER-2/neu oncogene amplification in primary breast cancer. The South Australia Breast Cancer Study Group. J Clin Oncol. 1993 Oct; 11(10):1936-1942. 8105035
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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