AmoyDx® Essential NGS panel approval from Chinese authority
Date:2018-11-21Source: AmoyDx

AmoyDx® Essential NGS panel was approved by Chinese National Medical Products Administration (NMPA) on November 20, 2018, for qualitative detection of gene mutations in patients with Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer (CRC). It is the first Companion Diagnostic (CDx) NGS kit approved in China covering different cancer types.

AmoyDx® Essential NGS panel is a library preparation kit based on Illumina platform, involved EGFR, ALK, ROS1, RET, KRAS, NRAS, PIK3CA, BRAF, HER2, and MET genes which are mostly recommended for mutation detection by the guidelines for NSCLC and CRC. Among the 10 genes, EGFR mutation testing was approved as CDx solution with Gefitinib & Osimertinib, ALK and ROS1 fusion testing were approved as CDx with Crizotinib on NSCLC, and KRAS mutation testing was approved as CDx with Cetuximab on CRC. 
With the innovative patented ddCapture® technology, AmoyDx® Essential NGS panel has Limit of Detection (LOD) of 1%. While according to the validation data on Horizon® standard DNA, the mutations can be well detected on 0.5% allele frequency.
AmoyDx is the market leader in China providing cancer gene mutations testing kits to over 300 top-tier hospitals. Essential NGS panel is the first AmoyDx® NGS product approved by Chinese NMPA. AmoyDx product lines cover different technical platforms including qPCR, FISH and NGS, providing the most comprehensive solutions on cancer mutation testing for precision oncology in China and overseas.

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