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HER-2, IHC, with Interpretation
Test Code30316
CPT Codes
88360
Preferred Specimen
Formalin-fixed, paraffin-embedded tumor tissue block submitted in an IHC Specimen Transport kit
Other Acceptable Specimens
5 unstained (4 micron) sections, positively charged tissue on Poly-L-Lysine or Silane coated slides
Instructions
Tumor paraffin block (formalin-fixed only) or five 4-micron unstained sections on Poly-L-Lysine or Silane coated slides. See Specimen Collection Section, Oncology. Please submit stained H & E slide and a copy of the pathology report. Do not place paper labels with adhesive backing on slides. Use pencil or xylene resistant pen to write on the frosted end of the slide only. Invasive or metastatic breast cancer formalin fixed paraffin embedded tissue or charged/+slides from formalin fixed paraffin embedded tissue.
Specimen MUST be fixed in 10% neutral buffered formalin. Fixation between 6 and 72 hours is recommended. Pathology report must accompany paraffin block or slides. Information required in this report include: Physician identification, specimen identifiers (case and block number), specimen site and type, tissue processing used (routine or microwave), type of fixative, time and duration of fixation, pathologic diagnosis, and IHC score, if performed elsewhere.
Ship at room temperature. Do not freeze.
Specimen MUST be fixed in 10% neutral buffered formalin. Fixation between 6 and 72 hours is recommended. Pathology report must accompany paraffin block or slides. Information required in this report include: Physician identification, specimen identifiers (case and block number), specimen site and type, tissue processing used (routine or microwave), type of fixative, time and duration of fixation, pathologic diagnosis, and IHC score, if performed elsewhere.
Ship at room temperature. Do not freeze.
Transport Container
IHC Specimen Transport Kit
Transport Temperature
Room temperature
Specimen Stability
Room temperature: Indefinitely
Refrigerated: Indefinitely
Frozen: Unacceptable
Refrigerated: Indefinitely
Frozen: Unacceptable
Methodology
Immunohistochemical Assay (IHC)
Setup Schedule
Set up: Monday-Friday Morning Report available: 2 days
Limitations
Lack of HER-2 protein overexpression or gene amplification suggests the patient will not respond to trastuzumab therapy; however, clinical trials are needed to confirm this presumption. Similarly, trastuzumab response, or lack thereof, in patients with confirmed equivocal HER-2 test results is uncertain. Trastuzumab is clinically indicated only for patients in whom HER-2 protein overexpression or gene amplification can be confirmed.
Reference Range
See Laboratory Report
Clinical Significance
HER-2 is associated with cellular proliferation activity. Overexpression is observed in 25-30% of women with breast cancer. These patients are potential candidates for monoclonal therapy.
