HER2 Testing in Breast Cancer (by LabCE)

2 P.A.C.E. contact hour(s)

(based on 148 customer ratings)

Author: Kathryn R. Perkinson, BS, HTL(ASCP)
Reviewers: Jim Burchette, HT(ASCP); Donna Hedger, BS, HT(ASCP)

Course provided by LabCE.

HER2/neu is a useful tumor marker for therapeutic decision making in patients with breast cancer. This course includes a review current breast cancer statistics, a comparison of methods used for HER2/neu testing, proper interpretation of HER2/neu fluorescence in situ hybridization (FISH), and the College of American Pathologists (CAP) guidelines for HER2/neu FISH testing.

See more courses in: Histology

Included In These Course Packages

Continuing Education Credits

P.A.C.E.® Contact Hours (acceptable for AMT, ASCP, and state recertification): 2 hour(s)
Course number 578-023-21, approved through 2/28/2023
Course number 20-815580, approved through 2/28/2023


  • Review current breast cancer statistics.
  • Compare methods for HER2 testing.
  • Understand the College of American Pathologists (CAP) guidelines for HER2 fluorescence in situ hybridization (FISH) testing.
  • Outline the method for HER2 FISH assay.
  • Demonstrate proper interpretation of HER2 FISH assay.

Customer Ratings

(based on 148 customer ratings)

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Course Outline

  • Introduction
      • Overview
  • Theoretical Background
      • HER2: The Protein and the Gene
      • HER2 Protein Overexpression and Gene Amplification
  • Clinical Utility of HER2/neu Testing
      • Clinical Utility of HER2 Testing
      • Herceptin® (Trastuzumab)
      • Herceptin® (Trastuzumab): Additional Information
      • Testing for HER2: Sensitivity Versus Specificity
      • Herceptin® (Trastuzumab) Response
  • Clinical Testing for HER2/neu
      • Testing Methodologies
      • History of Testing for HER2: Timeline
      • History of Testing for HER2: Early Trials used Immunohistochemistry (IHC) testing
      • Testing Algorithms
      • HER2 by Immunohistochemistry (IHC)
      • HER2 by In Situ Hybridization (ISH) Methods
      • Additional Testing Methods for HER2
  • Methods to Assess HER2/neu Status
      • Fluorescence in Situ Hybridization (FISH) Versus Immunohistochemistry (IHC)
  • Immunohistochemical (IHC) methods
      • Summary of HER2 Immunohistochemical (IHC) Method
      • Patients with Immunohistochemistry (IHC) 2+ Tumors
      • Interpretation of HER2 Immunohistochemistry (IHC)
      • Interpretation of HER2 Immunohistochemistry (IHC): Agilent Dako HercepTest™
      • Fluorescence In Situ Hybridization (FISH)
      • Fluorescence In Situ Hybridization (FISH): Definitions
      • Need for Hematoxylin and Eosin (H&E) Slide
      • Breast Cancer Sample - Normal for HER2 Gene Copy Number
      • Polysomy of Chromosome 17 in Breast Cancer
      • HER2 Fluorescence in Situ Hybridization (FISH) Slide - Positive for Gene Amplification
      • HER2 Fluorescence in Situ Hybridization (FISH) Interpretation
      • Fluorescence in Situ Hybridization (FISH): Equivocal Results
      • Test Systems Without a Chromosome 17 Centromere Signal to Enumerate
  • Testing Inaccuracies - Discordant Results between IHC and FISH
      • Discordant Results between Immunohistochemistry (IHC) and Fluorescence in Situ Hybridization (FISH)
      • Test Inaccuracies
      • Pre-Analytical Causes of Test Inaccuracies
      • Analytical Causes of Test Inaccuracies
      • Use of Image Analysis to Reduce Analytical Phase Testing Inaccuracies
      • Post-Analytical Causes of Test Inaccuracies
      • College of American Pathologists' (CAP) Guidelines for HER2
      • Pre-Analytic Guidelines
      • HER2 FISH Specimen Handling Requirements
      • Analytic Guidelines
      • Analytic Guidelines: Interpretation
      • Pathologist Competency
      • Guidelines: Quality Management
      • Validation Criteria
      • What is the Gold Standard?
  • References
      • References

Additional Information

Level of instruction: Beginning to intermediate
Intended audience:  Clinical laboratory histotechnologists, histotechnicians, and other medical laboratory personnel who have an interest in this subject matter. This course is also appropriate for histology and clinical laboratory science students, pathology residents, and practicing pathologists.  
Author information: Kathryn R. Perkinson, BS, HTL(ASCP) has been the manager of the Molecular Pathology Department of Duke University Health System in Durham, North Carolina since 1998.  She holds a Bachelor of Science degree in biochemistry from North Carolina State University. Kathryn has over 25 years of experience in molecular biology in both the research and clinical healthcare fields at Duke University. The Molecular Pathology Department, under her leadership, has tripled in size over the past 15 years. 
Reviewer information: Jim Burchette, HT(ASCP) is retired from Duke University Medical Center, Durham, North Carolina as an Immunopathology Analytical Specialist in Molecular Pathology. He has over 38 years of experience in surgical pathology histotechnology with 33 years of immunopathology specialty. Jim has authored numerous peer-reviewed publications, (www.pubmed.com; search burchette j), two book chapters, and many abstracts, posters, and technical acknowledgments in peer reviewed scientific articles. Jim served as a consultant for Triangle Biomedical Sciences (TBS), Dako North America, Leica Microsystems, and Polysciences.
Reviewer information: Donna M. Hedger, BS, HT(ASCP) is the Pathology Manager at Gwinnett Hospital System in Lawrenceville, Georgia. She graduated from Georgia Southern University with a Bachelor of Science in Biology. She is a certified histotechnician.
Course description: HER2 is a useful tumor marker for therapeutic decision making in patients with breast cancer. This course includes a review of current breast cancer statistics and compares various methods for HER2 testing. Information is based on the current ASCO/CAP HER2 Test Guideline Recommendations (2013). 

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Course provided by LabCE.
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HER2 testing timeline

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