Which HER2 tests are FDA approved to select patients for treatment with Herceptin?
• A: Several FDA-approved commercial assays are available to determine HER2 status and aid in the selection of patients for Herceptin. Approved immunohistochemistry (IHC) assays, which measure the level of expression of the HER2 protein, include HercepTest® and Pathway™.1 Approved FISH (fluorescence in situ hybridization) assays,which detect the underlying gene alteration in the patient’s tumor cells, include PathVysion® and HER2 FISH pharmDx™.1 Users should refer to the package inserts of specific assay kits for information on the validation and performance of each assay.
