AmoyDx® HER2 Mutation Detection Kit | 8.01.26801X024H

AmoyDx® HER2 Mutation Detection Kit | 8.01.26801X024H | Gentaur UK, US & Europe Distribution  

Human epidermal growth factor receptor 2 (HER2), also known as Neu, ErbB-2, CD340 (cluster of differentiation 340) or pl85, is encoded by a proto-oncogene ERBB2 which located at the long arm of human chromosome 17 (17ql2). Activating mutations in the tyrosine kinase domain of HER2 have been described in a subset of lung adenocarcinomas (ADCs) and are mutually exclusive with EGFR/KRAS/ALK driver mutations. HER2 mutations, consisting of in-frame insertions in exon 20, have been identified in approximately 2-4% of non-small cell lung cancer (NSCLC) patients. These insertions cause activation of downstream ZZER2-pathway components such as AKT and MEK.

Studies have shown that NSCLC patients harboring a HER2 exon 20 insertion are sensitive to trastuzumab (marketed as Herceptin) and the irreversible dual EGFR and HER2 TKIs, lapatinib, neratinib, and afatinib. However, the presence of this mutation is associated with primary resistance to the first generation EGFR TKIs, erlotinib and gefitinib. These studies highlighted the importance of screening for HER2 mutations in NSCLC and suggest that ZZER2-positive patients may be responsive to fZEZ?2-targeted therapy.

Intended Use

The AmoyDx® HER2 Mutation Detection Kit is a real-time PCR assay for qualitative detection of 13 mutations in HER2 gene in human genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) tumor tissue.

The kit is for research use only, and intended to be used by trained professionals in a laboratory environment.

Testing Procedure