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Validated Immunochemical Assay for Comprehensive Determination of the Human Epidermal Growth Factor Receptor 2 Released from and Bound to Cells
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2013 ASCO/CAP updated guidelines for human epidermal growth factor receptor 2 testing: Impact on routine practice
Ilaria Pennacchia1, Arnaldo Carbone1, Arcangelo Di Cerbo1
1Institute of Pathology, Catholic University of Sacred Heart, Rome, Italy.
Breast (Edinburgh, Scotland)
|February 24, 2015
Summary
New ASCO/CAP guidelines for human epidermal growth factor receptor 2 testing improved clarity, leading to increased use of ISH tests in routine practice. Lab data shows a rise in ISH testing post-guideline implementation.
Area of Science:
- Oncology
- Pathology
- Molecular Diagnostics
Background:
- The American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) updated guidelines for human epidermal growth factor receptor 2 (HER2) testing.
- These updates provided clearer definitions for immunohistochemistry (IHC) categories used in HER2 assessment.
Purpose of the Study:
- To evaluate the impact of the new ASCO/CAP guidelines on laboratory testing practices.
- To quantify changes in the utilization of in situ hybridization (ISH) tests for HER2 analysis following guideline implementation.
Main Methods:
- Comparative analysis of laboratory data from two six-month periods.
- The periods compared were the semester following the guideline release and the same semester in the preceding year.
Main Results:
- An increase in the number of ISH tests performed was observed after the implementation of the new guidelines.
- The study highlights the practical impact of guideline changes on daily laboratory workflow.
Conclusions:
- The revised ASCO/CAP guidelines have influenced diagnostic testing patterns for HER2.
- Clearer definitions likely contributed to increased reliance on ISH testing, impacting routine pathology practice.
