Course Outline
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- Introduction
- Theoretical Background
- Clinical Utility of HER2/neu Testing
- Clinical Utility of HER2 Testing
- Trastuzumab
- Trastuzumab: Additional Information
- Testing for HER2: Sensitivity versus Specificity
- True or False: Herceptin® is a drug that is used to treat patients with HER2-positive breast tumors.
- True or False: 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 versus Immunohistochemistry
- Which of the following are the two primary methods used to assess HER2 status in clinical laboratories?
- What are the benefits of using immunohistochemistry (IHC) as a marker for HER2 gene amplification?
- Immunohistochemical Methods
- Fluorescence in Situ Hybridization Testing
- Testing Inaccuracies: Discordant Results Between IHC and FISH
- HER2/neu Testing Guidelines
- College of American Pathologists' Guidelines for HER2
- Pre-Examination Guidelines: Specimen Handling Requirements
- Examination Guidelines: Assays
- Examination Guidelines: Interpretation
- Post-Examination Guideline: Pathologist Competency
- Quality Management
- Validation Criteria
- What is the Gold Standard?
- True or False: 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: Basic to intermediate
Intended Audience: Histotechnologists, histotechnicians, pathology assistants, and other medical laboratory personnel interested in this subject matter. This course is also appropriate for histology and medical 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 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.
The author has no conflict of interest to disclose.
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 and a Bachelor of Science in Biology from Troy University, Troy, Alabama. She is certified as a Histotechnician and has 25 years of experience in the field of Histology.
Erika Caceres, BS, HTL(ASCP), has nearly eight years of experience as a histotechnologist, progressing from bench technician to pathology supervisor. She has expertise in tissue preparation, staining, and advanced histological techniques, including immunohistochemistry. Her leadership roles at Atrium Health involved directing workflow, optimizing antibodies, and ensuring compliance with CAP and CLIA regulations. She earned a Bachelor of Science in Biology from Queens University of Charlotte, where she focused on microbiology and cell biology, followed by completing her Histotechnology training at Carolinas College of Health Sciences.
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 ASCO/CAP HER2 Test Guide.
