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Beaumont Laboratory

HER2 by Immunohistochemistry (IHC)

HER2, HER2/neu, Gastic Cancer HER2

Specimen Collection Criteria

Collect (preferred specimen): Formalin-fixed, paraffin-embedded block with corresponding H&E slide. Tissue shold be well fixed and well processed. Please provide a pathology report with each specimen, including type of fixative and hours duration of fixation (if known). Tissue must be fixed for a minimum of 6 hours and a maximum of 48 hours in 10% neutral buffered formalin. Indicate fixation time on test requistion form.
Also acceptable: One H&E slide plus 3 unstained tissue sections cut at 4.0 um thick and placed on charged slides. Air dry, do not oven dry. Tissue adherence cannot be guaranteed for sections placed on plain glass slides. Send all slides within 6 weeks of cutting.

Specimen must be accompanied by a completed requisition and must contain the patient name, date of birth, collection date, ordering physician, source of specimen, and fixation time, if known. Please provide a pathology report with each specimen.

Physician Office/Drawsite Specimen Preparation

Maintain paraffin-embedded tissue or slides at room temperature (20-25°C or 68-77°F) until transport.

Preparation for Courier Transport

Transport: Paraffin-embedded tissue or slides, at room temperature (20-26°C or 68-78.8°F).

Rejection Criteria

  • Tissue in fixatives other than 10% formalin.
  • Improper labeling, inadequate information.


Specimen Stability for Testing:

Paraffin-Embedded Tissue
Room Temperature (20-26°C or 68-78.8°F): Indefinitely
Refrigerated (2-8°C or 36-46°F): Unacceptable
Frozen (-20°C/-4°F or below): Unacceptable

Tissue Section on Glass Slides
Room Temperature (20-26°C or 68-78.8°F): 6 weeks
Refrigerated (2-8°C or 36-46°F): Unacceptable
Frozen (-20°C/-4°F or below): Unacceptable

Specimen Storage in Department Prior to Disposal:

Room Temperature (20-26°C or 68-78.8°F): 7 days


Royal Oak Anatomic Pathology - Advanced Diagnostics Laboratory.


Twice weekly.
Results available in 7 business days.

Reference Range

HER2 over-expression: This assay is intended to be performed on formalin-fixed tissue. The effects of other types of fixatives on the assay results have not been established.

IHC Intensity Result:

0: Negative
1+: Negative
2+: Equivocal
3+: Positive

This assay is performed in concordance with CAP/ASCO (2013) criteria on invasive tumor only. The kit used in the staining has been FDA approved for breast cancer only. Its use in other types of cancer should be considered only for investigational or research use. The results of the test can be altered/affected by variables beyond our laboratory's control, e.g. fixatives other than formalin and fixation times other than that recommended in CAP/ASCO guidelines.

Test Methodology

Immunoperoxidase staining and detection of HER2 is performed in formalin-fixed, paraffin-embedded tissue sections using polymer-based detection system. 4-micron tissue sections are deparaffinized, subjected to heat-induced antigen retrieval and then sequentially incubated with anti-receptor polyclonal antibody (HercepTest, Dake Inc) and followed by a polymer detection reagent. Sections are subsequently treated with the chromogen diaminobenzidine and the substrate hydrogen peroxide to produce a brown nuclear precipitate in cells expressing receptors. Sections are lightly counterstained with hematoxylin.


Immunoperoxidase-stained slides are examined by a pathologist who will provide an interpretive report. Results are reported as negative (0, 1+), equivocal (2+), and positive (3+) according to the interpretation guidelines in the FDA-approved HercepTest.

Clinical Utility

HER2 amplification or overexpression in breast, endometrial, ovarian, and other epithelial carcinomas has been associated with shorter disease-free interval and shorter overall survival. Women who have tumors that overexpress HER2 are most likely to be responsive to monoclonal antibody therapy directed against this target.

Approximately 20-25% of patients with gastric cancer have tumors which are HER2 positive. In this group, molecularly targeted therapy with trastuzumab added to cytotoxic chemotherapy improves overall survival and progression-free survival.


  1. Wolff, AC, Hammond, MEH, Hicks, DG et al. American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer. J Clin Oncol 2013 Nov 1; 31(31) 3997-4013.

CPT Code


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This directory currently reflects information only for specimens collected and/or processed at the Farmington Hills, Grosse Pointe, Royal Oak, and Troy campuses.