NMPA (CFDA) approved the ‘human 10 gene mutation combined detection kit’, manufactured by Amoy Diagnostics, the first of its kind in the CDx (companion diagnostic) category in China on November 20, 2018. The kit is intended for the detection of ten gene mutations for patients with non-small cell lung cancer (NSCLC) and colorectal cancer (CRC): EGFR, ALK, ROS1, RET, KRAS, NRAS, PIK3CA, BRAF, HER2, and MET. It can assist in the diagnosis to determine the benefits from anti-cancer drugs including Gefitinib, Oxitinib, Kezotinib, Cetuximab, etc. It is the first approval for multiple biomarker-based Next-Generation Sequencing (NGS) companion diagnostic (CDx) granted by NMPA.
FDA often grants Fast Track and Priority Review designations to CDx to shorten the time for market acceptance. Starting last year, NMPA began to follow suit and use the Innovation Approval for CDx. In January 2018, NMPA approved the first CDx, Super-ARMS® EGFR, a blood test product by Amoy Diagnostics. Following this approval, three additional approvals were granted for cancer-related CDx. Among the approvals are PD-L1 IHC 22C3 PharmDx, manufactured by Dako North America, Inc.
For slides of presentation regarding China IVD Registration & CDx, please email info@ChinaMedDevice.com.
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About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. As a certified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent overseas manufacturers for the complete product life cycle without their need to set up local entity in China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification.