HER2 IQFISH and FISH pharmDx™ Kits
In a fraction of patients (15-20%) with breast cancer, the HER2 gene is amplified as a part of the process of malignant transformation and tumor progression. HER2 gene amplification leads to overexpression of the HER2 protein on the surface of breast cancer cells.
HER2 gene amplification and receptor prevalence correlates with poor breast cancer prognosis, including relapse-free and overall survival.
The recombinant, humanized monoclonal antibody Herceptin™ was rationally developed to specifically target HER2-positive breast cancers. Demonstration of high HER2 overexpression or gene amplification is essential for treatment with Herceptin™. Clinical studies have shown that patients whose tumors have high HER2 receptor overexpression and/or amplification benefit most from Herceptin™ (1).
HercepTest™ was the first FDA-approved diagnostic kit designed to quickly and accurately identify patients eligible for Herceptin™ therapy.
HER2 FISH pharmDx™ Kit is the second FDA-approved Dako HER2 diagnostic kit indicated as an aid in the assessment of patients for whom Herceptin™ treatment is considered.
- Bilous M, Dowsett M, Hanna W, Isola J, Lebeau A, Moreno A, et al. Current perspectives on HER2 testing: a review of national testing guidelines. Mol Pathol 2003:16;173-82.