HER2 Testing in Breast Cancer
American Society of Clinical Oncology, College of American PathologistsPublished: June 7, 2023
- 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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