Product Description

HER2 Mutation Detection Kit Qualitative detection of Detection of five mutations in HER2 gene
 
HER2mutations, consisting of in-frame insertions in exon *0, have been identified in approximately 2~4%of nonsmall-cell lung cancers (NSCLC). HER2 mutations appear to be found more commonly in never smokerswith adenocarcinoma histology. These insertions causeactivation of downstream HER*-pathway components such as AKT and MEK. Drugstargeting HER2 include traztuzumab, lapatinib, pertuzumab, afatinib, neratinib andT-DMI. A recent study by Mazieres[1] highlighted the importance of screeningfor HER2 mutations in NSCLC and suggests that HER*-positive patients may beresponsive to HER*-targeted therapy.
 
Reference:
Buttitta F, et al., Mutational analysis of the HER2 gene in lung tumors from Caucasian patients: mutations are mainly present in adenocarcinomas with bronchioloalveolar features.Int J Cancer ***6 JulienMazie, et al., Lung Cancer That Harbors a HER2 Mutation: Epidemiologic Characteristics andTherapeutic Perspectives. Journal of clinical oncology ***3  
Intended Use
The AmoyDx®HER2 Mutation Detection Kit is an in vitro nucleic acid amplification test intended for qualitative detection offive HER2 insertion mutationsin human NSCLCtissue, formalin-fixed paraffin-embedded (FFPE) tissue or pleural effusion samples.
This kit is intended for research use only.
 
Technological Principles
 
The kit uses novel, proprietary primers and probes in a real-time PCR assay to detect five HER2 mutations in human genomic DNA. The mutantHER2 gene is amplified by the specific primers, and detected by the novel probes.
 
5 HER2 insertion mutations in exon *0 detected by the kit: