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Test Name:
HER-2/neu, Paraffin Block, by FISH
- SBMF No:
38553 - Performance Lab Name:
Flow Cytometry/Molecular Pathology - Test Mnemonic:
PRFN CERB - ABN:
Not required - CPT Code:
88368x2 - Test Includes:
Ratio of HER-2 neu signals/Chromosome 17 - Also Known As:
Human Epidermal Growth Factor-2 (HER-2) - Spec Type:
Tissue section - Spec Container:
Formalin-fixed paraffin-embedded (FFPE) invasive breast tumor tissue
Note: Use 10% neutral buffered formalin - Spec Store Transport:
Room temperature - Spec Reject:
Paraffin-embedded tissue does not contain tumor, or only contains ductal carcinoma in situ
Tissue fixed in solution other than 10% neutral buffered formalin, such as, Bouin’s or Zenker’s - Methodology:
Fluorescence in Situ Hybridization (FISH) - Use:
The results of this test are used as an adjunct to existing clinical and pathologic prognostic factors currently used in stage II, node-positive, breast cancer patients (e.g., tumor size, number of involved lymph nodes, and steroid receptor status)
This test can also be used as an aid to predict disease-free and overall survival in patients with stage II, node-positive, breast cancer treated with adjuvant cyclosplamide, doxorubicin, and 5-fluorouracil chemotherapy - Clinical Significance:
The evaluation of HER-2/neu currently has two clinical functions: the first is that of a predictive marker for response to Herceptin® therapy and the second is that of a prognostic marker. - Reference Range:
Negative: ratio of less than 1.8 HER-2/neu signals per chromosome 17
Equivocal: ratio of 1.8 to 2.2 HER-2/neu signals per chromosome 17
Positive: ratio of greater than 2.2 HER-2/neu signals per chromosome 17 - Day Run:
Mon-Thu - Time Run:
9:00 am - Time Reported:
48 hours - Test Type:
AP
