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Navigating Human Epidermal Growth Factor Receptor 2 (HER2) Assessment by Organ Systems: A Guidebook to HER2 Testing
Context.—:
Human epidermal growth factor receptor 2 (HER2) may show protein overexpression and/or gene amplification in a subset of carcinomas at various sites. Recent developments in HER2-directed therapies have increased the need to optimize HER2 testing, assessment, and reporting of HER2 status. Seven of 11 active biomarker reporting templates developed by the College of American Pathologists include elements for capturing HER2 status, which has presented challenges to accommodate different scoring systems and allow clear, concise reporting.
Objective.—:
To evaluate the current evidence for HER2 testing, interpretation, and reporting in different tumor types, and to create a guidebook for navigating HER2 assessment by organ systems to improve the accuracy of HER2 testing and its utility as a predictive marker in carcinomas of various primary sites.
Design.—:
The Biomarker Project Team, composed of members of the College of American Pathologists serving on different committees (Cancer, Pathology Electronic Reporting, Immunohistochemistry, Center Guideline, Molecular Oncology), set out to create a guideline for HER2 testing, assessment, and reporting.
Results.—:
The Biomarker Project Team identified indications for HER2 testing, scoring criteria, and optimal reporting in carcinomas of different organ systems to improve the accuracy of HER2 (ERBB2) testing by immunohistochemistry and in situ hybridization.
Conclusions.—:
This guidebook reviews the current guidelines for HER2 testing and reporting in carcinomas of different organ systems. In addition, it discusses the challenges of designing a unified biomarker reporting format to cover alternative scoring systems.
Insights
Optimizing human epidermal growth factor receptor 2 (HER2) testing is crucial for targeted therapies. This guidebook provides a standardized approach to HER2 assessment and reporting across various carcinomas, improving diagnostic accuracy.
Area of Science:
- Oncology
- Pathology
- Biomarker Analysis
Background:
- Human epidermal growth factor receptor 2 (HER2) overexpression/amplification occurs in various carcinomas.
- Advancements in HER2-targeted therapies necessitate optimized HER2 testing, assessment, and reporting.
- Existing biomarker reporting templates present challenges in accommodating diverse HER2 scoring systems.
Purpose of the Study:
- To evaluate current evidence for HER2 testing, interpretation, and reporting across tumor types.
- To develop a guidebook for navigating HER2 assessment by organ system.
- To enhance the accuracy and utility of HER2 testing as a predictive marker.
Main Methods:
- A multidisciplinary Biomarker Project Team developed a guideline for HER2 testing.
- Indications for HER2 testing, scoring criteria, and reporting were identified.
- Guideline development involved input from College of American Pathologists committees.
Main Results:
- The guidebook reviews current HER2 testing and reporting guidelines for different organ systems.
- It addresses challenges in creating a unified biomarker reporting format for varied scoring systems.
- Key elements for accurate HER2 (ERBB2) testing via immunohistochemistry and in situ hybridization are identified.
Conclusions:
- A standardized guidebook is essential for consistent HER2 testing and reporting.
- Addressing diverse scoring systems is critical for clear and concise HER2 status reporting.
- Improved HER2 assessment enhances its role as a predictive marker in cancer therapy.
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