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. | Product | Technology | Company | Certificate NO. | Approved Date | Sample type | Cancer | CDx |
| Domestic products | ||||||||
| 1 | Human EGFR/KRAS/BRAF/HER2/ALK/ROS1 Gene Mutation Detection Kit | Semiconductor sequencing (NGS) | Xiamen SPACEGEN Co.,Ltd | 20203400094 | 2020-01-22 | Tumor tissue | NSCLC | Gefitinib, Crizotinib, Icotinib hydrochloride, |
| 2 | Human 10 gene mutation joint detection kit | Reversible End Termination Sequencing Method (NGS) | Xiamen Amoy Diagnostics Co., Ltd. | 20183400507 | 2018-11-16 | Tumor tissue | NSCLC, CRC | Gefitinib, Crizotinib, Osimertinib mesylate |
| 3 | Human KRAS/NARS/BRAF Gene Mutation Joint Detection Kit | Fluorometric PCR | Xiamen Amoy Diagnostics Co., Ltd. | 20153401886 | 2015-10-14 | Tumor tissue | CRC | Not specified |
| 4 | Human BRAFV600E Gene Mutation Detection Kit | Fluorometric PCR | Xiamen Amoy Diagnostics Co., Ltd. | 20143401824 | 2019-04-18 | Tumor tissue | CRC, Melanoma, thyroid cancer, lung cancer | Not specified |
| 5 | 5 Gene Mutation detection kit | Fluorometric PCR | Xiamen Amoy Diagnostics Co., Ltd. | 20183401043 | 2018-08-12 | Tumor tissue | NSCLC | Not specified |
| 6 | Human 8 gene mutation joint detection kit | Semiconductor sequencing (NGS) | Genetron Health Ltd. | 20203400072 | 2020-01-22 | Tumor tissue | NSCLC | Gefitinib, Icotinib hydrochloride, Crizotinib, Osimertinib mesylate |
| 7 | B-raf gene mutation detection kit | Genechip | Zhuhai Sinochips Biotech Ltd. | 20173400164 | 2017-01-23 | Tumor tissue | Not specified | Not specified |
| 8 | B-raf gene mutation detection kit | fluorometric PCR-capillary electrophoresis | Beijing SinoMD Gene Detection Co. | 20153401453 | 2015-08-18 | Tumor tissue | CRC | Not specified |
| 9 | Human K-ras and B-raf gene mutation detection kit | PCR-Fluorescent Probe Method | Shanghai YUANQI Biotech Ltd. | 20163402135 | 2016-09-28 | Tumor tissue | Melanoma, CRC, lung cancer | Not specified |
| 10 | Human BRAF Gene Mutation Detection Kit | Fluorometric PCR | GuangZhou Biotron Biotechnology Co., Ltd. | 20183401029 | 2018-03-12 | Tumor tissue | CRC, Melanoma, thyroid cancer | Not specified |
| 11 | Human BRAF Gene Mutation Detection Kit | Fluorometric PCR | HELIXGEN (Guangzhou) Co., Ltd. | 20153400157 | 2019-03-11 | Tumor tissue | Not specified | Not specified |
| 12 | Human BRAF Gene Mutation Detection Kit | Fluorometric PCR | Beijing ACCB Biotech Ltd. | 20183401826 | 2018-09-20 | Tumor tissue | NSCLC, CRC, Thyroid cancer | Not specified |
| 13 | Human BRAFV600E Gene Mutation Detection Kit | PCR-Fluorescent Probe Method | Wuhan YZY Biopharma Co., Ltd | 20153400257 | 2019-12-04 | Tumor tissue | CRC | Not specified |
| 14 | Human EGFR， KRAS, BRAF, PIK3CA, ALK, ROS1 Gene Mutation Detection Kit | Semiconductor sequencing (NGS) | Tianjin Novogene Bioinformatics Technology Company LTD | 20183400294 | 2018-08-11 | Tumor tissue | NSCLC | Not specified |
| 15 | Human EGFR/ALK/ BRAF/ KRAS Gene Mutation Joint Detection Kit | Reversible End Termination Sequencing Method (NGS) | Guanzhou Burning Rock Biotech Co., Ltd. | 20183400286 | 2018-07-18 | Tumor tissue | NSCLC | Not specified |
| 16 | EGFR/ALK/ROS1/BRAF/KRAS/HER2 gene mutation detection kit | Reversible End Termination Sequencing Method (NGS) | Nanjing Geneseeq medical devices Ltd. | 20183400408 | 2018-09-28 | Tumor tissue | NSCLC | Not specified |
| Imported products | ||||||||
| 17 | Anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody Reagents | Immunohistochemistry | Ventana Medical Systems,Inc. | 20153402062 | 2015-07-02 | Tumor tissue | Not specified | Not specified |
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