Fish Analysis, HER-2/NEU for Breast Cancer

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Pseudonyms: HER-2, HER-2/neu Amplification, erb-b2, erb-b2 Amplification, Breast Cancer, Breast Carcinoma, FISH

TESTING METHODOLOGY: Fluorescence in situ hybridization
  • Collect: Tumor tissue
  • Specimens: Paraffin-embedded, formalin-fixed (FFPE) tissue block or five 4 µm sections on positively-charged glass slides including one consecutive hematoxylin and eosin-stained (H and E) section with the tumor areas marked. Optimal fixation should be between 6 and 48 hours in 10% neutral buffered formalin. Do not oven dry the slides
  • Stability: Paraffin block: ambient temperature, indefinite
  • Unacceptable Conditions: Tissue not verified for the presence of invasive carcinoma; carcinoma in situ is not acceptable; specimens fixed in fixatives other than formalin

A FISH HER-2 Specimen Working Submission form must accompany the specimen. Contact the Cytogenetics Laboratory at 918-502-1722 to obtain further information

Test Summary: Test is designed to determine the presence of amplification of the HER-2/neu oncogene in invasive breast carcinoma cells
Method: A dual-color FISH analysis performed on interphase nuclei using the dual-color PathVysion HER-2 probe set with the HER-2/neu gene probe and a probe for chromosome 17 (D17Z1); analysis of 20 to 40 interphase nuclei from invasive carcinoma cells
Interpretation: A HER2:CEP17 ratio >2.2 indicates HER2 amplification, a HER2:CEP17 ratio of 1.8 to 2.2 is considered equivocal, and HER2:CEP17 ratio of <1.8 is considered not amplified.
Reference Values: An interpretive report will be provided. The results are interpreted using the American Society of Clinical Oncology/College of American Pathologists guidelines (2007, 2009).
FDA Approval: This test is approved for in vitro diagnostic testing for invasive breast cancer
Indications for Use:
  • Identify the presence of HER-2 amplification in patients with invasive breast cancer
  • Determine the HER-2 gene status in breast cancer specimens with HER-2 over-expression or equivocal expression by immunohistochemistry
  • Prognostic indicator for patients with invasive breast cancer
  • Guide therapy decisions for patients with invasive breast cancer for whom Herceptin (Trastuzumab) treatment is being considered