HER-2/CEP17, FISH

CPT: 88377
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Test Details

Use

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

Limitations

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.

Methodology

Fluorescence in situ hybridization (FISH)

Specimen Requirements

Specimen

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

Volume

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

Container

Paraffin block transport pouch or slide mailer

Collection

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

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

References

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 ME, Hicks DG, et al. Recommendations for HER2 testing in breast cancer: ASCP/CAP clinical practice guideline update. J Clin Oncol. 2013 Nov 1; 31(31): 3997-4013.

LOINC® Map

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

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