HER2 Testing in Breast Cancer
Publication Date: June 7, 2023
Key Points
Key Points
Recommendations by the American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) human epidermal growth factor receptor 2 (HER2) Testing Expert Panel are aimed at improving the analytic validity of HER2 testing and the clinical utility of HER2 as a predictive biomarker for potential responsiveness to therapies targeting the HER2 protein.
HER2 gene amplification assessed by in situ hybridization (ISH) or protein overexpression assessed by immunohistochemistry (IHC) remains the primary predictors of responsiveness to HER2-targeted therapies in breast cancer.
Greater communication among health-care providers (especially pathologists and oncologists) and appropriate infrastructure support for specimen handling and laboratory facilities have led to observed improvements in the analytic performance and accuracy of HER2 testing.
HER2 gene amplification assessed by in situ hybridization (ISH) or protein overexpression assessed by immunohistochemistry (IHC) remains the primary predictors of responsiveness to HER2-targeted therapies in breast cancer.
Greater communication among health-care providers (especially pathologists and oncologists) and appropriate infrastructure support for specimen handling and laboratory facilities have led to observed improvements in the analytic performance and accuracy of HER2 testing.
Highlights
...Highlights...
All newly diagnosed patients with...
...as a HER2/CEP17 ratio is ≥2.0 but the avera...
...ase has an average of ≥6.0 HER2 signals/c...
...case has an average HER2 signals/tumor cell...
ISH Testing
...ISH TestingISH test is r...
Acceptable (IHC and ISH) Tests
...Acceptab...
Reporting Requirements For All Assay Types
Optimal Tissue Handling Requirements
...Optimal Tissue Handling Req...
Optimal Tissue Sectioning Requirements
...Optimal Tissue Section...
Optimal Internal Validation Procedure
...Optimal Internal...