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Quantitative Image Analysis of HER2 Immunohistochemistry for Breast Cancer


An expert panel comprised of pathologists and histotechnologists with expertise in digital pathology, immunohistochemistry (IHC), quality management, and breast pathology developed recommendations for improving reproducibility, precision, and accuracy in the interpretation of HER2 IHC for breast cancer performed by quantitative image analysis (QIA).

Our evidence-based guideline "Quantitative Image Analysis Of HER2 Immunohistochemistry For Breast Cancer," is published in the Archives of Pathology & Laboratory Medicine. This guideline aims to ensure accurate QIA diagnoses by answering these key questions:

  1. What equipment validation and daily performance monitoring is needed?
  2. What training of staff and pathologists is required? What are the competency assessments needs over time?
  3. How does one select or develop an appropriate algorithm for interpretation?
  4. How does one determine the performance of the image analysis?
  5. How should image analysis be reported?

Guideline Tools and Resources

The following tools and resources are available to help implement the guideline:

External Endorsement

The American Society for Clinical Pathology (ASCP) enthusiastically endorses the guideline through informed consideration by the ASCP Commission on Science, Technology & Policy.

The Association for Pathology Informatics (API) formally endorses the guideline through the API Council.


Find CME offerings for pathologists.

HER2 Tissue Donations

Donate laboratory tissue samples for the CAP proficiency testing programs. Contact the Purchasing team at mpspurc@cap.org.

Accreditation Requirements and Proficiency Testing (PT)

Accreditation checklist requirements regarding HER2 assay validation, specimen fixation, proficiency testing, and use of the ASCO/CAP scoring criteria for reporting results are included in the anatomic pathology (ANP), cytogenetics (CYG), and molecular pathology (MOL) checklists.

These checklists are available to CAP accredited laboratories through e-LAB Solutions Suite.

Non-CAP accredited laboratories may purchase these checklists through our order form by non-CAP accredited laboratories.

Meet PT requirements by ordering the appropriate HER2 PT program. Call the CAP customer contact center at 1-800-323-4040 option 1#.

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