HER2 IHC Lauch_Landing Page Mockup_V1_HER2-IHCtesting-Landing-Hero

We added HER2 IHC to our portfolio following the FDA’s approval of trastuzumab deruxtecan as the first antibody-drug conjugate (ADC) with a tumor-agnostic indication for previously treated adults with unresectable or metastatic HER2-positive solid tumors.

This new indication expands treatment options for patients, and we want to make sure you have the information you need to guide appropriate therapy selection – so that you don’t miss even one treatment option for your patients.

You may also order HER2 IHC as an add-on to our other comprehensive genomic profiling (CGP) tests; please contact Client Services at 888.988.3639 for details.


If you would like someone from Foundation Medicine to contact you about HER2 IHC testing, please share your information below. 

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FoundationOne®CDx is a qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors and is for prescription use only. The test analyzes 324 genes as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment.  A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For the complete label, including companion diagnostic indications and important risk information, please visit

Ventana Medical Systems, Inc.'s (Ventana) PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PATHWAY HER2 (4B5)) is a rabbit monoclonal antibody intended for in vitro diagnostic (IVD) use for the semi-quantitative detection of HER2 antigen in sections of formalin-fixed, paraffin-embedded normal and neoplastic tissue. This assay is FDA-approved and it is indicated as an aid in the assessment of breast cancer patients for whom Herceptin® (trastuzumab), Enhertu® (trastuzumab deruxtecan), or KADCYLA® (ado-trastuzumab emtansine) treatment is being considered. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.