Special Instructions
Please direct any questions regarding this test to oncology customer service at 800-345-4363.
Expected Turnaround Time
3 - 5 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Information
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
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)
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 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
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 | ||
| 483248 | HER-2/CEP17 FISH | 483002 | Director Review | N/A |
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