What are the FDA-approved HER2 tests of breast tumors?

Updated: Mar 20, 2019
  • Author: Oudai Hassan, MD; Chief Editor: Chandandeep Nagi, MD  more...
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There is no criterion standard assay for HER2 in breast cancer. Immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) are both used. Available data do not clearly demonstrate the superiority of either IHC or in situ hybridization as a predictor of benefit from anti-HER2 therapy. In 2007, the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) published a joint guideline regarding HER2 testing in breast cancer. [13] A list of the US Food and Drug Administration (FDA) approved tests is provided in Table 4.

Table 4. FDA-Approved Tests for HER2* (Open Table in a new window)



Link to Package Insert of  Manufacturer

Immunohistochemistry (IHC)

HercepTest (DAKO Denmark A/S, Glostrup, Denmark)

A085 polyclonal antibody


(Revision 2019.01)

Pathway HER2 (4B5) rabbit monoclonal primary antibody (Ventana Medical Systems, Inc, Tucson, AZ)

CB11 monoclonal antibody


Fluorescence  in situ hybridization (FISH)

PathVysion HER2 DNA probe kit (Abbott Molecular, Inc, Des Plaines, IL, USA)

Hybridization of fluorescent DNA probes to the HER2 gene (orange) and chromosome 17 centromere (CEP17, green). CEP17 is a centromeric probe for chromosome 17 on which the HER2 gene resides used as an internal control probe.


Dual ISH DNA Probe

INFORM HER2/neu Dual ISH DNA Probe Cocktail Assay (Ventana Medical Systems, Inc, Tucson, AZ)

Enumeration of the ratio of the HER2 gene to chromosome 17 with the use of standard light microscopy on one slide, via co-hybridization of HER2 probe (labeled with the hapten dinitrophenyl [DNP]) and a chromosome 17 probe (labeled with the hapten digoxigenin [DIG]). 



http://productlibrary.ventana.com/ventana_portal/OpenOverlayServlet?launchIndex=1&objectId=780-44221003271US (6/2/2017; 1003271US Rev E)

*In addition to these commercially available tests, "home brew" IHC and FISH assays are accepted, if properly validated.


A previously available chromogenic in situ hybridization (CISH) assay (SPoT-Light HER2 CISH Kit, Invitrogen Corporation, Carlsbad, CA) was recalled in 2012, and subsequently discontinued by the manufacturer, owing to potential contamination of the diagnostic reagent with a fungal contaminant. [14]

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