Test Catalog

Test ID: H2BR    
HER2 Amplification Associated with Breast Cancer, FISH, Tissue

Useful For Suggests clinical disorders or settings where the test may be helpful

A predictive marker for patients with both node-positive or node-negative primary and metastatic breast cancer


Patients with HER2 amplification that may be candidates for therapies targeting the human epidermal growth factor receptor 2 (HER2) protein (eg, trastuzumab [Herceptin], pertuzumab, lapatinib)


Confirming the presence of HER2 amplification in cases with 2+ (low level) or 3+ (high level) HER2 overexpression by immunohistochemistry, and for certain histologic subtypes with aberrant patterns of HER2 expression seen by immunohistochemistry (eg, micropapillary carcinoma)

Reflex Tests Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test IDReporting NameAvailable SeparatelyAlways Performed
HERBNHER Breast IHC Automated NO ReflexYesNo

Testing Algorithm Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Reflex testing will be performed using immunohistochemistry (IHC) when the FISH result falls within certain ranges as defined by the 2018 focused update to the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.(1) For FISH results in ASCO/CAP categories Group 2, 3, and 4 (formerly called "equivocal"), the IHC testing will be added, charged, and reported separately. An integrated interpretation of the IHC and FISH results will be provided (see Interpretation).


A charge and CPT code is applied for each probe set hybridized, analyzed, and reported.

Method Name A short description of the method used to perform the test

Fluorescence In Situ Hybridization (FISH)

NY State Available Indicates the status of NY State approval and if the test is orderable for NY State clients.


Reporting Name Lists a shorter or abbreviated version of the Published Name for a test

HER2, Breast Tumor, FISH, Tissue

Aliases Lists additional common names for a test, as an aid in searching

Breast Carcinoma
c-erb-b2 Amplification Test (FISH)