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

Synonyms

  • HERmark® Reflex

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 immunotherapies

Limitations

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.

Methodology

Fluorescence in situ hybridization (FISH)

Specimen Requirements

Specimen

Tumor (formalin-fixed, paraffin-embedded)

Volume

One paraffin block or eight 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

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.

References

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

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
483410 HER-2/CEP17 Reflex HERmark(R) 483249 HER-2/neu FISH 31150-6
483410 HER-2/CEP17 Reflex HERmark(R) 483299 HER-2/CEP17 Ratio 49683-6
483410 HER-2/CEP17 Reflex HERmark(R) 483328 Avg Num Her-2 signals/nucleus: 74860-8
483410 HER-2/CEP17 Reflex HERmark(R) 483329 Avg Num CEP17 probes/nucleus: 74861-6
483410 HER-2/CEP17 Reflex HERmark(R) 483332 Number of Tumor Cells Counted: 62361-1
483410 HER-2/CEP17 Reflex HERmark(R) 483334 Number of Observers: N/A
483410 HER-2/CEP17 Reflex HERmark(R) 483259 Fixation Time N/A
483410 HER-2/CEP17 Reflex HERmark(R) 483260 Fixative N/A
483410 HER-2/CEP17 Reflex HERmark(R) 483336 Scoring Criteria 19147-8
483410 HER-2/CEP17 Reflex HERmark(R) 483006 Director Review N/A
483410 HER-2/CEP17 Reflex HERmark(R) 483317 Reflex to HERmark(R) N/A
Reflex Table for Reflex to HERmark(R)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 482009 HERmark(R) 482011 HERmark(R) PDF 11526-1
Reflex Table for Reflex to HERmark(R)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 482009 HERmark(R) 482010 HERmark(R) HER2 Status 72383-3
Reflex Table for Reflex to HERmark(R)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 482009 HERmark(R) 482013 HERmark(R) Quantitative Result 72382-5
Reflex Table for Reflex to HERmark(R)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 482009 HERmark(R) 482017 HERmark(R) Ranges 19147-8
Reflex Table for Reflex to HERmark(R)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 482009 HERmark(R) 482015 HERmark(R) Interpretation 77202-0
Reflex Table for Reflex to HERmark(R)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 482009 HERmark(R) 482016 HERmark(R) Methodology 49549-9

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