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CPT: 88377
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Special Instructions

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

Expected Turnaround Time

3 - 5 days

Specimen Requirements


Formalin-fixed, paraffin-embedded (FFPE) tumor (tissue block)


One paraffin block or four 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

Test Details


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


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

Results of the HER-2/CEP17 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)


Mass RD, Press M, Anderson S, et al. Improved survival benefit from Herceptin in patients selected by fluorescent 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 MEH, Allison KH, et al. Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. J Clin Oncol. 2018 Jul 10;36(20):2105-2122.29846122


Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
483248 HER-2/CEP17 FISH 483249 HER-2/neu FISH 31150-6
483248 HER-2/CEP17 FISH 483299 HER-2/CEP17 Ratio 49683-6
483248 HER-2/CEP17 FISH 483328 Avg Num Her-2 signals/nucleus: 74860-8
483248 HER-2/CEP17 FISH 483329 Avg Num CEP17 probes/nucleus: 74861-6
483248 HER-2/CEP17 FISH 483332 Number of Tumor Cells Counted: 62361-1
483248 HER-2/CEP17 FISH 483334 Number of Observers: n/a
483248 HER-2/CEP17 FISH 483259 Fixation Time n/a
483248 HER-2/CEP17 FISH 483260 Fixative n/a
483248 HER-2/CEP17 FISH 483336 Scoring Criteria 19147-8
483248 HER-2/CEP17 FISH 483002 Director Review n/a

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