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NMPA approved BRAF mutation detection kits


Oncology biomarker testing, as an important tool to guide the treatment of targeted therapy, has been one of the hottest areas for IVD manufactures world-wide. BRAF gene mutations are one of the mostly studied biomarkers and the assays for BRAF gene mutation detection have been developed and marketed for relevant therapeutics. In China, there are 17 NMPA approved test kits can be used for BRAF mutation detection (table 1). Eight of them are PCR-based tests and six of them is based on NGS platform.  Only one of the approved tests is produced by overseas manufacturers.

Table 1. Summary of NMPA approved tests kits for BRAF gene mutation detection

NO.ProductTechnologyCompany Certificate NO.Approved DateSample typeCancerCDx
Domestic products
1Human EGFR/KRAS/BRAF/HER2/ALK/ROS1 Gene Mutation Detection Kit Semiconductor sequencing (NGS)Xiamen SPACEGEN Co.,Ltd202034000942020-01-22Tumor tissueNSCLCGefitinib, Crizotinib, Icotinib hydrochloride,
2Human 10 gene mutation joint detection kitReversible End Termination Sequencing Method (NGS)Xiamen Amoy Diagnostics Co., Ltd. 201834005072018-11-16Tumor tissueNSCLC, CRCGefitinib, Crizotinib, Osimertinib mesylate
3Human KRAS/NARS/BRAF Gene Mutation Joint Detection Kit Fluorometric PCRXiamen Amoy Diagnostics Co., Ltd. 201534018862015-10-14Tumor tissueCRCNot specified
4Human BRAFV600E Gene Mutation Detection Kit Fluorometric PCRXiamen Amoy Diagnostics Co., Ltd. 201434018242019-04-18Tumor tissueCRC, Melanoma, thyroid cancer, lung cancerNot specified
55 Gene Mutation detection kitFluorometric PCRXiamen Amoy Diagnostics Co., Ltd. 201834010432018-08-12Tumor tissueNSCLCNot specified
6Human 8 gene mutation joint detection kitSemiconductor sequencing (NGS)Genetron Health Ltd.202034000722020-01-22Tumor tissueNSCLCGefitinib, Icotinib hydrochloride, Crizotinib, Osimertinib mesylate
7B-raf gene mutation detection kitGenechipZhuhai Sinochips Biotech Ltd.201734001642017-01-23Tumor tissueNot specifiedNot specified
8B-raf gene mutation detection kitfluorometric PCR-capillary electrophoresisBeijing SinoMD Gene Detection Co.201534014532015-08-18Tumor tissueCRCNot specified
9Human K-ras and B-raf gene mutation detection kitPCR-Fluorescent Probe MethodShanghai YUANQI Biotech Ltd.201634021352016-09-28Tumor tissueMelanoma, CRC, lung cancerNot specified
10Human BRAF Gene Mutation Detection Kit Fluorometric PCRGuangZhou Biotron Biotechnology Co., Ltd.20183401029
Tumor tissueCRC, Melanoma, thyroid cancerNot specified
11Human BRAF Gene Mutation Detection Kit Fluorometric PCRHELIXGEN (Guangzhou) Co., Ltd.201534001572019-03-11Tumor tissueNot specifiedNot specified
12Human BRAF Gene Mutation Detection Kit Fluorometric PCRBeijing ACCB Biotech Ltd.201834018262018-09-20Tumor tissueNSCLC, CRC, Thyroid cancerNot specified
13Human BRAFV600E Gene Mutation Detection Kit PCR-Fluorescent Probe MethodWuhan YZY Biopharma Co., Ltd20153400257
Tumor tissueCRCNot specified
14Human EGFR, KRAS, BRAF, PIK3CA, ALK, ROS1 Gene Mutation Detection Kit Semiconductor sequencing (NGS)Tianjin Novogene Bioinformatics Technology Company LTD201834002942018-08-11Tumor tissueNSCLCNot specified
15Human EGFR/ALK/ BRAF/ KRAS Gene Mutation Joint Detection Kit Reversible End Termination Sequencing Method (NGS)Guanzhou Burning Rock Biotech Co., Ltd.201834002862018-07-18Tumor tissueNSCLCNot specified
16EGFR/ALK/ROS1/BRAF/KRAS/HER2 gene mutation detection kitReversible End Termination Sequencing Method (NGS)Nanjing Geneseeq medical devices Ltd.201834004082018-09-28Tumor tissueNSCLCNot specified
Imported products
17Anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody ReagentsImmunohistochemistryVentana Medical Systems,Inc.201534020622015-07-02Tumor tissueNot specifiedNot specified

China Med Device provides turnkey solutions for China RA/QA/CRO and commercialization in IVD/CDX Products. If you would like to get more information about China IVD/CDx market approval, please do not hesitate to contact us.

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