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Arch Pathol Lab Med. 2019 Jan 15. doi: 10.5858/arpa.2018-0378-CP. [Epub ahead of print]

Quantitative Image Analysis of Human Epidermal Growth Factor Receptor 2 Immunohistochemistry for Breast Cancer: Guideline From the College of American Pathologists.

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From the Department of Anatomic Pathology, H. Lee Moffitt Cancer Center, Tampa, Florida (Dr Bui); the Department of Pathology, University of Texas MD Anderson Cancer Center, Houston (Dr Riben); the Department of Pathology, Stanford University Medical Center, Stanford, California (Dr Allison); Premier Laboratory, Longmont, Colorado (Ms Chlipala); Surveys (Mses Colasacco and Thomas), College of American Pathologists, Northfield, Illinois; the Department of Pathology, University of South Alabama, Mobile (Dr Kahn); Policy and Advocacy, American Society of Clinical Oncology, Alexandria, Virginia (Ms Lacchetti); the Department of Biomedical Engineering, Case Western Reserve University, Cleveland, Ohio (Dr Madabhushi); the Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (Dr Pantanowitz); the Department of Pathology, University of Utah/ARUP Laboratories Inc, Salt Lake City (Dr Salama); the Department of Pathology, University of Kentucky, Lexington (Dr Stewart); the Department of Pathology and Anatomical Sciences, University at Buffalo, State University of New York, Buffalo (Dr Tomaszewski); and the Department of Pathology, University of Utah School of Medicine and Intermountain Healthcare, Salt Lake City (Dr Hammond).



Advancements in genomic, computing, and imaging technology have spurred new opportunities to use quantitative image analysis (QIA) for diagnostic testing.


To develop evidence-based recommendations to improve accuracy, precision, and reproducibility in the interpretation of human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) for breast cancer where QIA is used.


The College of American Pathologists (CAP) convened a panel of pathologists, histotechnologists, and computer scientists with expertise in image analysis, immunohistochemistry, quality management, and breast pathology to develop recommendations for QIA of HER2 IHC in breast cancer. A systematic review of the literature was conducted to address 5 key questions. Final recommendations were derived from strength of evidence, open comment feedback, expert panel consensus, and advisory panel review.


Eleven recommendations were drafted: 7 based on CAP laboratory accreditation requirements and 4 based on expert consensus opinions. A 3-week open comment period received 180 comments from more than 150 participants.


To improve accurate, precise, and reproducible interpretation of HER2 IHC results for breast cancer, QIA and procedures must be validated before implementation, followed by regular maintenance and ongoing evaluation of quality control and quality assurance. HER2 QIA performance, interpretation, and reporting should be supervised by pathologists with expertise in QIA.


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