New Zealand
HER2 IQFISH and FISH pharmDx™ Kits
The human HER2 gene with the generic name ERBB2 (also known as NEU) encodes the HER2 protein or p185HER2. The HER2 protein is a membrane receptor tyrosine kinase with homology to the epidermal growth factor receptor (EGFR). The HER2 gene is a normal component present in two copies in all normal diploid cells.
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 IQFISH pharmDx™ is the latest FDA-approved Dako HER2 diagnostic kit indicated as an aid in the assessment of patients for whom Herceptin™ treatment is considered.
Reference:
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 IQFISH pharmDx™ is the latest FDA-approved Dako HER2 diagnostic kit indicated as an aid in the assessment of patients for whom Herceptin™ treatment is considered.
Reference:
- 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.