HER2 Testing in Breast Cancer

Published: May 2018
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  • Key Points
  • ISH Testing
  • Acceptable (IHC and ISH) Tests
  • Reporting Requirements For All Assay Types
  • Optimal Tissue Handling Requirements
  • Optimal Tissue Sectioning Requirements
  • Optimal Internal Validation Procedure
  • Optimal Initial Test Validation
  • Optimal Monitoring of Test Concordance Between Methods
  • Optimal Internal QA Procedures
  • Optimal External Proficiency Assessment
  • Optimal Laboratory Accreditation
  • Algorithms
    • Evaluation of HER2 Protein Expression by IHC Assay of the Invasive Component of a Breast Cancer Specimen
    • Evaluation of HER2 Gene Amplification by ISH Assay of the Invasive Component of a Breast Cancer Specimen Using a Single-signal (HER2 Gene) Assay (Single-probe ISH)
    • Evaluation of HER2 Gene Amplification by ISH Assay of the Invasive Component of a Breast Cancer Specimen Using a Dual-signal (HER2 gene) Assay (Dual-probe ISH)
    • Clinical Question 3 "Group 2"
    • Clinical Question 4 "Group 3"
    • Clinical Question 5 "Group 4"
  • Table
  • Histopathologic Features Suggestive of Possible HER2 Test Discordance
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Founded in 1964, the American Society of Clinical Oncology is the world's leading professional organization for physicians and oncology professionals caring for people with cancer.

The College of American Pathologists is the world's leading organization of board-certified pathologists.

Description

This pocket guide is derived from recommendations in the American Society of Clinical Oncology Guideline. This resource is a practice tool based on ASCO® practice guidelines and is not intended to substitute for the independent professional judgment of the treating physician. Practice guidelines do not account for individual variation among patients. This pocket guide does not purport to suggest any particular course of medical treatment. Use of the practice guidelines and this resource are voluntary. The practice guidelines and additional information are available at www.asco.org/supportive-care-guidelines. Copyright © 2021 by American Society of Clinical Oncology. All rights reserved.

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