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CAP Home > CAP Reference Resources and Publications > HER2 Testing Guidelines and Resources

HER2 Testing Guidelines and Resources

Updated April 18, 2011

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Changes to the HER2 Testing Guideline

Recommendations in the 2007 ASCO/CAP Guideline for HER2 Testing have been reconciled with the April 2010 ASCO/CAP ER PgR Guideline so that cancer specimens will be handled in a uniform manner for ER, PgR and HER2 in breast cancer specimens.

Read the Clinical Notice (PDF, 115 K)

See Easy Reference Reconciliation Table (PDF, 115 K)

A Clarification and Reminder about ASCO/CAP Guidelines on HER2 and ER/PgR Testing in Breast Cancer

A joint letter to the editor in the Journal of Clinical Oncology provides an important reminder of the intent of the ASCO and College of American Pathologists (CAP) guideline panel on Human Epidermal Growth Factor Receptor 2 (HER2) Testing, and also reconciles some pathology technical aspects with the recent guideline on Immunohistochemical Testing of Estrogen and Progesterone Receptor (ER and PgR) Testing in breast cancer. Read the letter by Elizabeth Hammond, MD, Daniel F. Hayes, MD and Antonio Wolff, MD, co-chairs of the ASCO/CAP guideline panels.

Summary of HER2 Recommendations – Revised
(PDF, 226 K)

See Frequently Asked Questions for information on specimen handling for HER2 and ER/PgR testing. In addition, see the FAQs for guidance on application of HER2 testing in gastric carcinoma.

HER2 Testing Guidelines HER2 Testing Guidelines

The College of American Pathologists (CAP) and the American Society of Clinical Oncology (ASCO) joint guideline on testing for HER2 status in invasive breast cancer

CAP and ASCO Press Release
(PDF, 50 KB)

Comment on the guidelines

Resources Resources

Frequently asked questions about the HER2 testing guidelines

PowerPoint Presentation

February 6, 2007: The CAP/ ASCO Guidelines Presentation has been updated by the author on 1/11/07

View presentation (PDF, 1.5 MB)

Information for patients

HER2 Tissue Donations HER2 Tissue Donations

Donation Form (Word, 32 KB)

HIPAA Form (PDF, 82 KB)

Accreditation Requirements Accreditation Requirements for
     HER2 Testing

The most recent CAP Laboratory Accreditation Program requirements for HER2 testing were published in the June, 2010 edition of the LAP Checklists. These new requirements continue to assure the quality of HER2 testing provided by accredited laboratories and to incorporate the CAP/ASCO HER2 testing guidelines into the CAP accreditation program.

Proficiency Testing Requirements

CAP accredited laboratories performing HER2 testing by immunohistochemistry or fluorescence in situ hybridization are required to enroll and participate in CAP-accepted proficiency testing. Performance will be monitored where laboratories must receive a passing score of 90% or better on each mailing to be considered successful. Laboratories that send HER2 slides to another facility for processing/staining and have them returned for interpretation will be required to participate in PT.

CAP HER2 Proficiency Testing CAP HER2 Proficiency
     Testing

You can meet the PT requirements as outlined in the newly adopted CAP/ASCO HER2 testing guidelines and the updated CAP accreditation checklists with CAP Surveys.

To order the appropriate program(s) for your laboratory, please call the CAP Customer Contact Center at 1-800-323-4040 option 1 #.

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