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- Theoretical Background
- HER2: The Protein and the Gene
- HER2 Protein Overexpression and Gene Amplification
- HER2 is overexpressed in over 50% of breast cancers.
- HER2 is a member of the epidermal growth factor receptor (EGFR) family of oncogenes.
- HER2 is located on chromosome 20.
- Clinical Utility of HER2/neu Testing
- Clinical Testing for HER2/neu
- Methods to Assess HER2/neu Status
- Fluorescence in Situ Hybridization (FISH) Versus Immunohistochemistry (IHC)
- Which of the following are the two primary methods used to assess HER2 status is clinical laboratories?
- What are the benefits of using immunohistochemistry (IHC) as a marker for HER2 gene amplification? (Choose all that apply.)
- Immunohistochemical (IHC) methods
- FISH TESTING
- 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
- HER2 immunohistochemistry (IHC) scores of 1+, 2+, and 3+ are ALL considered positive for HER2.
- HER2/NEU TESTING GUIDELINES
- 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?
- Fluorescence in situ hybridization (FISH) is the gold standard for HER2 testing.
- Which of the following is the range for optimal fixation times for HER2 FISH testing?
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.
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).