HER2 Mutation Detection Kit
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Amoy Diagnostics Co.,Ltd.
Amoy Diagnostics Co., Ltd. (AmoyDx) focuses on molecular diagnostics for oncology precision medicine. With completely independent intellectual property rights of ADx-ARMS and Super-ARMS technologies, AmoyDx has a market-leading portfolio of molecular diagnostic kits including but not limited to EGFR, RAS, ALK, BRAF, PIK3CA and ROS1 testing kits, which were firstly approved by CFDA and CE certified.
In European EMQN and Chinese PQCC quality control programs, AmoyDx is the NO.1 testing kit supplier for some years and always achieves the highest accuracy rate. Nowadays AmoyDx serves an extensive domestic and international oncology network reaching over 300 hospitals in China and 50 countries all over the world. Every year hundreds of thousands of cancer patients benefit from AmoyDx products.
AmoyDx is strategic diagnostics partner of AstraZeneca, Boehringer-Ingelheim, Pfizer, Merck and Illumina, providing diagnostic products and services for medicine development and clinical oncology practice. AmoyDx ROS1 kit was recently approved by Japanese authority PMDA as the sole companion diagnostic kit for Pfizer’s crizotinib, which became the 1st approved CDx kit in the world for lung cancer patients’ ROS1 testing.
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Qualitative detection of Detection of five mutations in HER2 gene
HER2 mutations in exons 19~20, have been identified in approximately 2~4%of non–small-cell lung cancers (NSCLC). HER2 mutations appear to be found more commonly in never smokers with adenocarcinoma histology. The most common mutation is an in-frame insertion in exon 20. These insertions cause activation of downstream HER2-pathway components such as AKT and MEK. Drugs targeting HER2 include afatinib, traztuzumab, lapatinib, pertuzumab, neratinib and T-DMI. A recent study by Mazieres highlighted the importance of screening for HER2 mutations in NSCLC and suggests that HER2-positive patients may be responsive to HER2-targeted therapy.
1. 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 2006
2. JulienMazie, et al., Lung Cancer That Harbors a HER2 Mutation: Epidemiologic Characteristics andTherapeutic Perspectives. Journal of clinical oncology 2013
The AmoyDx®HER2 Mutation Detection Kit is an in vitro nucleic acid amplification test intended for qualitative detection of 13 HER2 somatic mutations in human NSCLC formalin-fixed paraffin-embedded (FFPE) tissue, fresh tissue or pleural effusion samples.
This kit is intended for research use only.
The kit uses novel, proprietary primers and probes in a real-time PCR assay to detect 13 HER2 mutations in human genomic DNA. The mutantHER2 gene is amplified by the specific primers, and detected by the fluorescent probes.
13 HER2 mutations detected by the kit:
2325_2326 ins12 (TACGTGATGGCT)
2324_2325 ins12 (ATACGTGATGGC)
2326_2327 ins3 (TGT)
2339_2340 ins9 (GGGCTCCCC)
2322_2323 ins12 (GCATACGTGATG)
2339_2340 ins9 (GGGCTCCCC)
2340_2341 ins9 (GGCTCCCCA)
2326_2327 ins3 (TTT)
2339_2340 ins9 (CGGCTCCCC)