To address new information made available since the 2013 “Human Epidermal Growth Factor Receptor 2 (HER2) Testing in Breast Cancer” guideline update, a joint, focused update of the clinical practice guideline has been developed by an expert panel of pathologists and oncologists.
Notably, the 2018 Focused Update addresses uncommon clinical scenarios and improves clarity, particularly for infrequent HER2 test results that are of uncertain biologic or clinical significance. Updated findings of note include:
- Revision of the definition of IHC 2+ (equivocal) to the original FDA-approved criteria.
- Repeat HER2 testing on a surgical specimen if the initially tested core biopsy is negative is no longer stated as mandatory. A new HER2 test may (no longer should) be ordered on the excision specimen on the basis of some criteria (such as tumor grade 3).
- A more rigorous interpretation criteria of the less common patterns that can be seen in about 5% of all cases when HER2 status in breast cancer is evaluated using a dual-probe ISH testing. These cases, described as ISH groups 2 to 4, should now be assessed using a diagnostic approach that includes a concomitant review of the IHC test, which will help the pathologist make a final determination of the tumor specimen as HER2 positive or negative.
- The Expert Panel also preferentially recommends the use of dual-probe instead of single-probe ISH assays, but it recognizes that several single-probe ISH assays have regulatory approval in many parts of the world.
The complete focused update is published in the Archives of Pathology & Laboratory Medicine.
- Guideline status: Active
- Originally published: January 2007
- Update published: February 2014
- Focused Update published online ahead of print: May30, 2018
- Focused Update published in print:November 2018
Guideline Tools & Resources
Stakeholders are encourage to review and download the following resources to help implement the Focused Update:
- American Society of Clinical Oncology
Find CME offerings for pathologists.
HER2 Tissue Donations
Donate laboratory tissue samples for the CAP proficiency testing programs. Contact the Purchasing team at email@example.com.
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.
CAP accredited laboratories may access these checklists 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#.
Information for Patients
Review more CAP evidence-based guidelines by the Center.