Course Outline
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- Introduction
- Theoretical Background
- Clinical Utility of HER2/neu Testing
- Clinical Utility of HER2 Testing
- Herceptin® (Trastuzumab)
- Herceptin® (Trastuzumab): Additional Information
- Testing for HER2: Sensitivity Versus Specificity
- Herceptin® is a drug that is used to treat patients with HER2-positive breast tumors.
- Herceptin® is associated with LOW cost and cardiac toxicity.
- Herceptin® (Trastuzumab) Response
- 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
- HER2/NEU TESTING GUIDELINES
- College of American Pathologists' (CAP) Guidelines for HER2
- Pre-Analytic Guidelines: Specimen Handling Requirements
- Analytic Guidelines: Assays
- Analytic Guidelines: Interpretation
- Post Analytic Guideline: Pathologist Competency
- 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?
- 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: Carla J. Shoffeitt, MSM, HT(ASCP) is the Manager of the Pathology Department of Emory St. Joseph’s Hospital of Emory Healthcare in Atlanta, Georgia. She holds a Master of Science Degree in Healthcare Management as well as a Bachelor of Science degree in Biology from Troy University, Troy, Alabama. She is certified as a Histotechnician and has 25 years of experience in the field of Histology.
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 Guid
