Quantitative image analysis of human epidermal growth factor receptor 2 immunohistochemistry for breast cancer: Guideline from the college of American pathologists

Marilyn M. Bui, Michael W. Riben, Kimberly H. Allison, Elizabeth Chlipala, Carol Colasacco, Andrea G. Kahn, Christina Lacchetti, Anant Madabhushi, Liron Pantanowitz, Mohamed E. Salama, Rachel L. Stewart, Nicole E. Thomas, John E. Tomaszewski, M. Elizabeth Hammond

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

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

Original languageEnglish (US)
Pages (from-to)1180-1195
Number of pages16
JournalArchives of Pathology and Laboratory Medicine
Volume143
Issue number10
DOIs
StatePublished - Jan 1 2019

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Immunohistochemistry
Guidelines
Breast Neoplasms
Accreditation
Expert Testimony
Quality Control
Breast
Maintenance
Pathology
Technology
Pathologists
human ERBB2 protein

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Medical Laboratory Technology

Cite this

Quantitative image analysis of human epidermal growth factor receptor 2 immunohistochemistry for breast cancer : Guideline from the college of American pathologists. / Bui, Marilyn M.; Riben, Michael W.; Allison, Kimberly H.; Chlipala, Elizabeth; Colasacco, Carol; Kahn, Andrea G.; Lacchetti, Christina; Madabhushi, Anant; Pantanowitz, Liron; Salama, Mohamed E.; Stewart, Rachel L.; Thomas, Nicole E.; Tomaszewski, John E.; Hammond, M. Elizabeth.

In: Archives of Pathology and Laboratory Medicine, Vol. 143, No. 10, 01.01.2019, p. 1180-1195.

Research output: Contribution to journalArticle

Bui, MM, Riben, MW, Allison, KH, Chlipala, E, Colasacco, C, Kahn, AG, Lacchetti, C, Madabhushi, A, Pantanowitz, L, Salama, ME, Stewart, RL, Thomas, NE, Tomaszewski, JE & Hammond, ME 2019, 'Quantitative image analysis of human epidermal growth factor receptor 2 immunohistochemistry for breast cancer: Guideline from the college of American pathologists', Archives of Pathology and Laboratory Medicine, vol. 143, no. 10, pp. 1180-1195. https://doi.org/10.5858/arpa.2018-0378-CP
Bui, Marilyn M. ; Riben, Michael W. ; Allison, Kimberly H. ; Chlipala, Elizabeth ; Colasacco, Carol ; Kahn, Andrea G. ; Lacchetti, Christina ; Madabhushi, Anant ; Pantanowitz, Liron ; Salama, Mohamed E. ; Stewart, Rachel L. ; Thomas, Nicole E. ; Tomaszewski, John E. ; Hammond, M. Elizabeth. / Quantitative image analysis of human epidermal growth factor receptor 2 immunohistochemistry for breast cancer : Guideline from the college of American pathologists. In: Archives of Pathology and Laboratory Medicine. 2019 ; Vol. 143, No. 10. pp. 1180-1195.
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