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Test ID: HER2I    
HER2 Immunostain, Technical Component Only

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Useful For Suggests clinical disorders or settings where the test may be helpful

Identification of HER2 protein overexpression in formalin-fixed, paraffin-embedded tissue sections

Testing Algorithm Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

For the initial technical component only immunohistochemical (IHC) stain performed, the appropriate bill-only test ID will be reflexed and charged (IHTOI). For each additional technical component only IHC stain performed, an additional bill-only test ID will be reflexed and charged (IHTOA).

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

The human HER2 gene (also known as ERBB2 or NEU) encodes a protein often referred to as HER2 protein or P185(HER2). The HER2 protein is a membrane receptor tyrosine kinase with homology to the epidermal growth factor receptor (EGFR or HER1). The HER2 protein is a normal component expressed by a variety of epithelial cell types.

Interpretation Provides information to assist in interpretation of the test results

This test does not include pathologist interpretation, only technical performance of the stain. If interpretation is required order PATHC / Pathology Consultation for a full diagnostic evaluation or second opinion of the case.

 

The positive and negative controls are verified as showing appropriate immunoreactivity and documentation is retained at Mayo Clinic Rochester. If a control tissue is not included on the slide, a scanned image of the relevant quality control tissue is available upon request; call 855-516-8404.

 

Interpretation of this test should be performed in the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Age of a cut paraffin section can affect immunoreactivity. Stability thresholds vary widely among published literature and are antigen dependent. Best practice is for paraffin sections to be cut within 6 weeks.

Clinical Reference Recommendations for in-depth reading of a clinical nature

1. Calhoun BC, Collins LC: Predictive markers in breast cancer: An update on ER and HER2 testing and reporting. Semin Diagn Pathol. 2015;32(5):362-369

2. Bahreini F, Soltanian AR, Mehdipour P: A meta-analysis on concordance between immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) to detect HER2 gene overexpression in breast cancer. Breast Cancer. 2015;22(6):615-625

3. Wolff AC, Hammond EH, 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;31(31):3997-4014