<\/p>\n
\u5f15\u7528\u672c\u6587\uff1a\u5f20\u745e, \u738b\u94ce, \u674e\u91d1\u660e. \u57fa\u4e8e\u68c0\u6d4b\u8303\u56f4\u52a8\u6001\u6269\u5c55\u6a21\u5f0f\u7684\u80bf\u7624\u9776\u5411\u548c\u514d\u75ab\u6cbb\u7597\u57fa\u56e0\u7a81\u53d8\u9ad8\u901a\u91cf\u6d4b\u5e8f\u89c4\u8303\u5316\u8def\u5f84 [J\/OL] . \u4e2d\u534e\u533b\u5b66\u6742\u5fd7, 2024,104\uff1a\u7f51\u7edc\u9884\u53d1\u8868. DOI: 10.3760\/cma.j.cn112137-20240105-00032.<\/p>\n
\u901a\u4fe1\u4f5c\u8005\uff1a\u674e\u91d1\u660e\uff0c\u5317\u4eac\u533b\u9662\u3000\u56fd\u5bb6\u8001\u5e74\u533b\u5b66\u4e2d\u5fc3\u3000\u56fd\u5bb6\u536b\u751f\u5065\u5eb7\u59d4\u4e34\u5e8a\u68c0\u9a8c\u4e2d\u5fc3\u3000\u4e2d\u56fd\u533b\u5b66\u79d1\u5b66\u9662\u8001\u5e74\u533b\u5b66\u7814\u7a76\u9662\uff0c\u5317\u4eac\u3000100730\uff0cEmail\uff1ajmli@nccl.org.cn.<\/p>\n
*\u672c\u6587\u5185\u5bb9\u5df2\u7ecf\u8fc7\u540c\u884c\u8bc4\u8bae\uff0c\u4f5c\u4e3a\u4f18\u5148\u51fa\u7248\u65b9\u5f0f\u5728\u7ebf\u53d1\u8868\uff0c\u53ef\u4f5c\u4e3a\u6709\u6548\u5f15\u7528\u6570\u636e\u3002\u7531\u4e8e\u4f18\u5148\u53d1\u8868\u7684\u5185\u5bb9\u5c1a\u672a\u5b8c\u6210\u89c4\u8303\u7684\u7f16\u6821\u6d41\u7a0b\uff0c\u300a\u4e2d\u534e\u533b\u5b66\u6742\u5fd7\u300b\u4e0d\u4fdd\u8bc1\u5176\u6570\u636e\u4e0e\u5370\u5237\u7248\u5185\u5bb9\u7684\u4e00\u81f4\u6027\u3002<\/p>\n
\u6458\u8981<\/p>\n
\u9ad8\u901a\u91cf\u6d4b\u5e8f\uff08NGS\uff09\u662f\u7cbe\u51c6\u80bf\u7624\u5b66\u7684\u5173\u952e\u6280\u672f\u652f\u6491\u3002\u80bf\u7624\u9776\u5411\u548c\u514d\u75ab\u6cbb\u7597\u57fa\u56e0\u7a81\u53d8NGS\u4e0d\u4ec5\u662f\u65b9\u6cd5\u539f\u7406\u7684\u521b\u65b0\uff0c\u540c\u65f6\u4e5f\u6709\u68c0\u6d4b\u7406\u5ff5\u7684\u53d8\u9769\uff1b\u80bf\u7624\u57fa\u56e0\u7a81\u53d8\u6807\u5fd7\u7269\u5e76\u975e\u56fa\u5b9a\u4e0d\u53d8\uff0c\u5176\u968f\u7740\u57fa\u7840\u7814\u7a76\u548c\u836f\u7269\u7814\u53d1\u8fdb\u5c55\u800c\u4e0d\u65ad\u66f4\u65b0\u3002\u80bf\u7624\u57fa\u56e0\u7a81\u53d8NGS\u68c0\u6d4b\u7684\u89c4\u8303\u5316\u5e94\u7ed3\u5408NGS\u65b9\u6cd5\u548c\u80bf\u7624\u6cbb\u7597\u57fa\u56e0\u7a81\u53d8\u6807\u5fd7\u7269\u7684\u7279\u70b9\u6765\u8fdb\u884c\u3002\u80bf\u7624\u6cbb\u7597\u57fa\u56e0\u7a81\u53d8NGS\u68c0\u6d4b\uff0c\u65e0\u8bba\u662f\u4f53\u5916\u8bca\u65ad\u4ea7\u54c1\uff0c\u8fd8\u662f\u81ea\u5efa\u65b9\u6cd5\uff0c\u5728\u65b9\u6cd5\u7814\u53d1\u548c\u4e34\u5e8a\u5e94\u7528\u8fc7\u7a0b\u4e2d\uff0c\u5728\u4e00\u4e2a\u786e\u5b9a\u7684\u68c0\u6d4b\u7cfb\u7edf\u4e0b\uff0c\u6839\u636e\u6807\u5fd7\u7269\u4e34\u5e8a\u8bc1\u636e\u7b49\u7ea7\u7684\u53d8\u5316\uff0c\u5728\u589e\u52a0\u8865\u5145\u65b0\u4f4d\u70b9\u5206\u6790\u6027\u80fd\u786e\u8ba4\u7ed3\u679c\u7684\u57fa\u7840\u4e0a\uff0c\u8fdb\u884c\u68c0\u6d4b\u8303\u56f4\u52a8\u6001\u6269\u5c55\uff0c\u662f\u5b9e\u73b0\u6700\u5927\u7a0b\u5ea6\u6ee1\u8db3\u80bf\u7624\u4e34\u5e8a\u8bca\u7597\u9700\u6c42\u4e14\u6709\u6548\u63a7\u5236\u98ce\u9669\u7684\u89c4\u8303\u5316\u8def\u5f84\u3002\u672c\u6587\u4e3b\u8981\u7ed3\u5408\u80bf\u7624\u9776\u5411\u548c\u514d\u75ab\u6cbb\u7597\u57fa\u56e0\u7a81\u53d8NGS\u68c0\u6d4b\u65b9\u6cd5\u7684\u7279\u70b9\u3001\u80bf\u7624\u57fa\u56e0\u7a81\u53d8\u6807\u5fd7\u7269\u7684\u7279\u70b9\u4ee5\u53ca\u76ee\u524d\u80bf\u7624\u57fa\u56e0\u7a81\u53d8NGS\u68c0\u6d4b\u89c4\u8303\u5316\u5e94\u7528\u7684\u73b0\u72b6\u8fdb\u884c\u8bba\u8ff0\uff0c\u63a2\u8ba8\u6211\u56fd\u80bf\u7624\u57fa\u56e0\u7a81\u53d8NGS\u68c0\u6d4b\u7684\u89c4\u8303\u5316\u8def\u5f84\u3002<\/p>\n
\u81ea2005\u5e74\u57fa\u4e8e\u7126\u78f7\u9178\u6d4b\u5e8f\u539f\u7406\u7684Genome Sequencer 20\u6d4b\u5e8f\u7cfb\u7edf\u51fa\u73b0\u4ee5\u6765\uff0c\u7ecf\u8fc7\u8fd120\u5e74\u7684\u53d1\u5c55\uff0c\u9ad8\u901a\u91cf\u6d4b\u5e8f\uff08high-throughput sequencing\uff09\u5373\u4e0b\u4e00\u4ee3\u6d4b\u5e8f\uff08next-generation sequencing\uff0cNGS\uff09\u6280\u672f\u65e5\u8d8b\u6210\u719f\uff0c\u5728\u65e0\u521b\u4ea7\u524d\u7b5b\u67e5\u3001\u80bf\u7624\u6cbb\u7597\u3001\u9057\u4f20\u75c5\u3001\u7f55\u89c1\u75c5\u4ee5\u53ca\u611f\u67d3\u6027\u75be\u75c5\u8bca\u65ad\u7b49\u9886\u57df\u5747\u5177\u6709\u91cd\u8981\u7684\u5e94\u7528\u4ef7\u503c\uff3b1\uff3d\u3002\u5176\u4e2d\uff0c\u7cbe\u51c6\u80bf\u7624\u5b66\u9886\u57df\u7814\u7a76\u8fdb\u5c55\u8fc5\u901f\uff0c\u5927\u91cf\u7684\u9776\u5411\u548c\u514d\u75ab\u6cbb\u7597\u836f\u7269\u6301\u7eed\u7814\u53d1\u548c\u4e0a\u5e02\uff0c\u540c\u65f6\u836f\u7269\u76f8\u5173\u7684\u57fa\u56e0\u7a81\u53d8\u4f4d\u70b9\u4e5f\u5728\u4e34\u5e8a\u7814\u7a76\u4e2d\u4e0d\u65ad\u88ab\u53d1\u73b0\uff3b2\uff3d\u3002\u4f46\u662f\uff0c\u7531\u4e8eNGS\u65b9\u6cd5\u5b66\u7684\u7279\u6b8a\u6027\u4ee5\u53ca\u80bf\u7624\u9776\u5411\u548c\u514d\u75ab\u6cbb\u7597\u57fa\u56e0\u7a81\u53d8\u4f4d\u70b9\u7684\u6301\u7eed\u66f4\u65b0\uff0c\u80bf\u7624\u57fa\u56e0\u7a81\u53d8NGS\u68c0\u6d4b\u4e34\u5e8a\u5e94\u7528\u5982\u4f55\u5e94\u5bf9\u8fd9\u79cd\u65e5\u65b0\u6708\u5f02\u7684\u66f4\u65b0\uff0c\u4fdd\u8bc1\u68c0\u6d4b\u7ed3\u679c\u7684\u4e34\u5e8a\u6709\u7528\u6027\uff0c\u662f\u4e00\u4e2a\u9700\u8981\u6df1\u5165\u8ba8\u8bba\u5e76\u660e\u786e\u7684\u91cd\u8981\u95ee\u9898\u3002\u672c\u6587\u5c06\u7ed3\u5408NGS\u6280\u672f\u3001\u80bf\u7624\u57fa\u56e0\u7a81\u53d8\u7684\u7279\u70b9\u4ee5\u53ca\u56fd\u5185\u5916\u76ee\u524d\u80bf\u7624\u57fa\u56e0\u7a81\u53d8NGS\u68c0\u6d4b\u89c4\u8303\u5316\u5e94\u7528\u7684\u73b0\u72b6\uff0c\u63a2\u8ba8\u6211\u56fd\u80bf\u7624\u57fa\u56e0\u7a81\u53d8NGS\u68c0\u6d4b\u7684\u89c4\u8303\u5316\u8def\u5f84\u3002<\/p>\n
\u4e00\u3001\u80bf\u7624\u9776\u5411\u548c\u514d\u75ab\u6cbb\u7597\u57fa\u56e0\u7a81\u53d8NGS\u68c0\u6d4b\u65b9\u6cd5\u7684\u7279\u70b9<\/p>\n
NGS\u6280\u672f\u53ef\u5b9e\u73b0\u4ece\u5355\u4e00\u6216\u5c11\u91cf\u6807\u5fd7\u7269\u7684\u68c0\u6d4b\uff0c\u8fdb\u5165\u5230\u540c\u65f6\u5bf9\u51e0\u767e\u3001\u4e0a\u5343\u751a\u81f3\u66f4\u591a\u57fa\u56e0\u68c0\u6d4b\u7684\u65b0\u6a21\u5f0f\uff0c\u5177\u6709\u5212\u65f6\u4ee3\u7684\u610f\u4e49\u3002\u4ee5\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08Food and Drug Administration\uff0cFDA\uff09\u6279\u51c6\u7684\u80bf\u7624\u57fa\u56e0\u7a81\u53d8NGS\u8bd5\u5242\uff3b\u901a\u5e38\u4e3a\u5b9e\u9a8c\u5ba4\u81ea\u5efa\u68c0\u6d4b\uff08laboratory-developed tests\uff0cLDTs\uff09\u6a21\u5f0f\uff3d\u4e3a\u4f8b\uff0cOncomineDx Target Test\u3001FoundationOneCDx\u3001MSK-IMPACT\u3001Omics Core\u3001PGDxelio tissue complete\u3001NYU Langone Genome PACT\u3001ACTOnco IVD\u548cxT CDx\u7b498\u79cdNGS\u8bd5\u5242\u6240\u68c0\u6d4b\u7684\u57fa\u56e0\u6570\u91cf\u5206\u522b\u4e3a23\u3001324\u3001468\u3001468\u3001505\u3001607\u3001440\u548c648\u4e2a\uff3b3\uff3d\u3002\u5982\u679c\u6d89\u53ca\u80bf\u7624\u514d\u75ab\u6cbb\u7597\u7597\u6548\u9884\u6d4b\u6807\u5fd7\u7269\uff0c\u5982\u80bf\u7624\u7a81\u53d8\u8d1f\u8377\uff08tumor mutation burden\uff0cTMB\uff09\u548c\u5fae\u536b\u661f\u4e0d\u7a33\u5b9a\u6027\uff08microsatellite instability\uff0cMSI\uff09\uff0c\u5219\u9700\u8981\u540c\u65f6\u5206\u6790\u591a\u8fbe\u6570\u767e\u4e2a\u80bf\u7624\u76f8\u5173\u57fa\u56e0\u6216\u4f4d\u70b9\uff3b4\uff3d\u3002<\/p>\n
\u4ece\u65b9\u6cd5\u539f\u7406\u6765\u8bf4\uff0c\u80bf\u7624\u57fa\u56e0\u7a81\u53d8NGS\u68c0\u6d4b\u901a\u5e38\u91c7\u7528\u9776\u5411\u63a2\u9488\u6355\u83b7\u6216\u5f15\u7269\u7279\u5f02\u6027\u6269\u589e\u7684\u65b9\u6cd5\u5b9e\u73b0\u5bf9\u7279\u5b9a\u57fa\u56e0\u7684\u9776\u5411\u6d4b\u5e8f\uff0c\u7136\u540e\u901a\u8fc7\u751f\u7269\u4fe1\u606f\u5b66\u5206\u6790\u8bc6\u522b\u7a81\u53d8\uff3b5\uff3d\u3002\u56e0\u6b64\uff0c\u5176\u68c0\u6d4b\u7b56\u7565\u4e3a\u5148\u5bf9\u9776\u5411\u533a\u57df\u5168\u90e8\u6d4b\u5e8f\uff0c\u7136\u540e\u5206\u6790\u8be5\u533a\u57df\u5185\u7684\u76ee\u6807\u4f4d\u70b9\uff0c\u5373\u201c\u6355\u9c7c\u201d\u6a21\u5f0f\u3002\u6362\u8a00\u4e4b\uff0cNGS\u65b9\u6cd5\u7684\u6d4b\u5e8f\u533a\u57df\u4e0e\u68c0\u6d4b\u8303\u56f4\u662f\u4e0d\u540c\u7684\uff0c\u68c0\u6d4b\u8303\u56f4\u662f\u6d4b\u5e8f\u533a\u57df\u4e2d\u4e34\u5e8a\u610f\u4e49\u660e\u786e\u4e14\u7ecf\u8fc7\u5206\u6790\u6027\u80fd\u786e\u8ba4\u7684\u7a81\u53d8\u6216\u4f4d\u70b9\uff0c\u662f\u6d4b\u5e8f\u533a\u57df\u7684\u4e00\u90e8\u5206\u3002\u800c\u5927\u90e8\u5206\u4f20\u7edf\u7684\u5206\u5b50\u68c0\u6d4b\u65b9\u6cd5\uff0c\u5982\u5b9e\u65f6\u8367\u5149PCR\uff0c\u901a\u8fc7\u5bf9\u7279\u5b9a\u7684\u57fa\u56e0\u7a81\u53d8\u6216\u4f4d\u70b9\u8bbe\u8ba1\u7279\u5f02\u6027\u7684\u5f15\u7269\u63a2\u9488\u5b9e\u73b0\u68c0\u6d4b\uff0c\u5373\u201c\u9493\u9c7c\u201d\u6a21\u5f0f\uff3b6\uff3d\u3002\u4f8b\u5982\uff0c\u67d0\u8bd5\u5242\u68c0\u6d4bEGFR L858R\u548cT790M\u7a81\u53d8\uff0c\u5219\u9700\u8981\u5206\u522b\u5efa\u7acb\u9776\u5411\u4e24\u79cd\u4f4d\u70b9\u7684\u4f53\u7cfb\uff0c\u9776\u5411\u4f4d\u70b9\u540c\u65f6\u4e5f\u662f\u68c0\u6d4b\u8303\u56f4\u3002\u56e0\u6b64\uff0c\u80bf\u7624\u57fa\u56e0\u7a81\u53d8NGS\u65b9\u6cd5\u5bf9\u4e8e\u4e34\u5e8a\u68c0\u6d4b\u6765\u8bf4\uff0c\u4e0d\u4ec5\u662f\u65b9\u6cd5\u539f\u7406\u7684\u521b\u65b0\uff0c\u540c\u65f6\u4e5f\u662f\u68c0\u6d4b\u7406\u5ff5\u7684\u53d8\u9769\u3002<\/p>\n
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\u56db\u3001\u7ed3\u8bed\u548c\u5c55\u671b<\/p>\n
NGS\u662f\u7cbe\u51c6\u80bf\u7624\u5b66\u53d1\u5c55\u7684\u91cd\u8981\u6280\u672f\u57fa\u7840\uff0c\u80bf\u7624\u57fa\u56e0\u7a81\u53d8NGS\u68c0\u6d4b\u7684\u89c4\u8303\u5316\u5e94\u7ed3\u5408NGS\u65b9\u6cd5\u548c\u80bf\u7624\u9776\u5411\u548c\u514d\u75ab\u6cbb\u7597\u57fa\u56e0\u7a81\u53d8\u6807\u5fd7\u7269\u7684\u7279\u70b9\u6765\u8fdb\u884c\u3002\u65e0\u8bba\u662f\u4f53\u5916\u8bca\u65ad\u4ea7\u54c1\uff0c\u8fd8\u662fLDTs\uff0c\u5728\u65b9\u6cd5\u7814\u53d1\u548c\u4e34\u5e8a\u5e94\u7528\u8fc7\u7a0b\u4e2d\uff0c\u5728\u4e00\u4e2a\u786e\u5b9a\u7684\u68c0\u6d4b\u7cfb\u7edf\u4e0b\uff0c\u6839\u636e\u6807\u5fd7\u7269\u4e34\u5e8a\u610f\u4e49\u7684\u53d8\u5316\uff0c\u5728\u589e\u52a0\u8865\u5145\u65b0\u4f4d\u70b9\u5206\u6790\u6027\u80fd\u786e\u8ba4\u7ed3\u679c\u7684\u57fa\u7840\u4e0a\uff0c\u8fdb\u884c\u68c0\u6d4b\u8303\u56f4\u52a8\u6001\u6269\u5c55\uff0c\u7ed3\u5408\u4e34\u5e8a\u5b9e\u9a8c\u5ba4\u7684\u8d28\u91cf\u7ba1\u7406\u548c\u63a7\u5236\uff0c\u662f\u6709\u6548\u6ee1\u8db3\u533b\u7597\u521b\u65b0\u4e14\u63a7\u5236\u98ce\u9669\u3001\u5b9e\u73b0\u201c\u610f\u4e49\u660e\u786e\u3001\u65b9\u6cd5\u53ef\u9760\u3001\u8fc7\u7a0b\u53ef\u63a7\u201d\u7684\u89c4\u8303\u5316\u8def\u5f84\u3002<\/p>\n
\u5229\u76ca\u51b2\u7a81<\/p>\n
\u6240\u6709\u4f5c\u8005\u58f0\u660e\u4e0d\u5b58\u5728\u5229\u76ca\u51b2\u7a81<\/p>\n
\u53c2\u8003\u6587\u732e\uff08\u4e0b\u6ed1\u67e5\u770b\uff09\uff1a<\/p>\n
[1]\u674e\u91d1\u660e.\u9ad8\u901a\u91cf\u6d4b\u5e8f\u6280\u672f[M].\u5317\u4eac:\u79d1\u5b66\u51fa\u7248\u793e,2018.<\/p>\n
[2]\u6768\u83b9,\u674e\u5b50\u660e,\u6731\u53ef\u55bb,\u00a0\u7b49.\u00a0\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u6cbb\u7597\u5e74\u5ea6\u8fdb\u5c552022[J].\u00a0\u4e2d\u534e\u533b\u5b66\u6742\u5fd7,\u00a02023,\u00a0103(14):1074-1081.\u00a0DOI:\u00a010.3760\/cma.j.cn112137-20221212-02628.<\/p>\n
[3]The U.S. Food and Drug Administration.\u00a0Nucleic acid based tests[EB\/OL].(2023-05-26)[2023-12-21].\u00a0https:\/\/www.fda.gov\/medical-devices\/in-vitro-diagnostics\/nucleic-acid-based-tests#human.<\/p>\n
[4]\u848b\u5706\u73b2,\u00a0\u6b27\u9633\u80fd\u592a.\u00a0\u9ad8\u901a\u91cf\u6d4b\u5e8f\u6280\u672f\u5728\u80bf\u7624\u7cbe\u51c6\u8bca\u7597\u4e2d\u7684\u4e34\u5e8a\u5e94\u7528[J].\u00a0\u4e2d\u534e\u68c0\u9a8c\u533b\u5b66\u6742\u5fd7,\u00a02023,\u00a046(9):893-898.\u00a0DOI:\u00a010.3760\/cma.j.cn114452-20230301-00029.<\/p>\n
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[7]CollinsFS,\u00a0VarmusH.\u00a0A new initiative on precision medicine[J].\u00a0N Engl J Med,\u00a02015,\u00a0372(9):793-795.\u00a0DOI:\u00a010.1056\/NEJMp1500523.<\/p>\n
[8]The U.S. Food and Drug Administration.\u00a0Oncology (cancer)\/hematologic malignancies approval notifications[EB\/OL]. (2024-02-16) [2024-02-22].\u00a0https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/oncology-cancer-hematologic-malignancies-approval-notifications.<\/p>\n
[9]The U.S. Food and Drug Administration.FDA grants accelerated approval to pembrolizumab for first tissue\/site agnostic indication\u00a0[EB\/OL]. (2017-05-30) [2023-12-21].https:\/\/wayback.archive-it.org\/7993\/20201220221801\/https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-grants-accelerated-approval-pembrolizumab-first-tissuesite-agnostic-indication.<\/p>\n
[10]The U.S. Food and Drug Administration.\u00a0FDA approves pembrolizumab for adults and children with TMB-H solid tumors\u00a0[EB\/OL]. (2020-06-17) [2023-12-21].\u00a0https:\/\/www.fda.gov\/drugs\/drug-approvals-and-databases\/fda- approves-pembrolizumab-adults-and-children-tmb-h-solid-tumors.<\/p>\n
[11]\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u529e\u516c\u5385,\u56fd\u5bb6\u536b\u751f\u548c\u8ba1\u5212\u8ba1\u751f\u80b2\u59d4\u5458\u4f1a\u529e\u516c\u5385.\u5173\u4e8e\u52a0\u5f3a\u4e34\u5e8a\u4f7f\u7528\u57fa\u56e0\u6d4b\u5e8f\u76f8\u5173\u4ea7\u54c1\u548c\u6280\u672f\u7ba1\u7406\u7684\u901a\u77e5[EB\/OL]. (2014-02-09) [2023-12-21].\u00a0https:\/\/www.nmpa.gov.cn\/xxgk\/fgwj\/gzwj\/gzwjylqx\/20140209120001776.html.<\/p>\n
[12]\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u56fd\u5bb6\u536b\u751f\u5065\u5eb7\u59d4\u5458\u4f1a\u5987\u5e7c\u5065\u5eb7\u53f8.\u300a\u89c4\u8303\u6709\u5e8f\u5f00\u5c55\u5b55\u5987\u5916\u5468\u8840\u80ce\u513f\u6e38\u79bbDNA\u4ea7\u524d\u7b5b\u67e5\u4e0e\u8bca\u65ad\u5de5\u4f5c\u7684\u901a\u77e5\u300b\u53ca\u6709\u5173\u6280\u672f\u89c4\u8303\u89e3\u8bfb[EB\/OL].(2016-11-09)[2023-12-21].\u00a0http:\/\/www.nhc.gov.cn\/fys\/s3582\/201611\/bcc3075de60441b8b6699dd12cb6338e.shtml.<\/p>\n
[13]\u5f20\u745e,\u00a0\u674e\u91d1\u660e.\u00a0\u80bf\u7624\u9776\u5411\u6cbb\u7597\u57fa\u56e0\u7a81\u53d8\u9ad8\u901a\u91cf\u6d4b\u5e8f\u68c0\u6d4b\u7684\u95ee\u9898\u4e0e\u601d\u8003[J].\u00a0\u4e2d\u534e\u533b\u5b66\u6742\u5fd7,\u00a02015,\u00a095(38):3081-3084.\u00a0DOI:\u00a010.3760\/cma.j.issn.0376-2491.2015.38.001.<\/p>\n
[14]\u5f20\u680b,\u00a0\u6768\u542f\u6587.\u00a0\u75c5\u539f\u5b8f\u57fa\u56e0\u7ec4\u68c0\u6d4b\u5e73\u53f0\u7684\u5efa\u8bbe\u4ee5\u53ca\u8d28\u91cf\u4fdd\u8bc1[J].\u00a0\u4e2d\u534e\u533b\u5b66\u6742\u5fd7,\u00a02023,\u00a0103(15):1092-1097.\u00a0DOI:\u00a010.3760\/cma.j.cn112137-20220825-01801.<\/p>\n
[15]\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u56fd\u52a1\u9662.\u533b\u7597\u5668\u68b0\u76d1\u7763\u7ba1\u7406\u6761\u4f8b[EB\/OL]. (2021-02-09) [2023-12-21].https:\/\/www.gov.cn\/zhengce\/2014-03\/31\/content_2651127.htm.<\/p>\n
[16]The U.S. Food and drug administration.\u00a0CDRH\u2032s Approach To Tumor Profiling Next Generation Sequencing Tests\u00a0[EB\/OL]. (2023-02-23) [2023-12-08]\u00a0https:\/\/www.fda.gov\/media\/109050\/download.<\/p>\n
[17]The U.S. Food and Drug Administration.\u00a0Summary of safety and effectiveness data (SSED)\u00a0[EB\/OL].(2024-01-12) [2024-03-12].https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf17\/P170019S048B.pdf.<\/p>\n
[18]The U.S. Food and Drug Administration.\u00a0Summary of safety and effectiveness data (SSED)\u00a0[EB\/OL]. (2023-10-06) [2023-12-08].\u00a0https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf17\/P170019S043B.pdf.<\/p>\n
[19]\u5317\u4eac\u5e02\u4e34\u5e8a\u68c0\u9a8c\u4e2d\u5fc3,\u00a0\u5317\u4eac\u533b\u5b66\u4f1a\u68c0\u9a8c\u533b\u5b66\u5206\u4f1a,\u00a0\u9996\u90fd\u533b\u79d1\u5927\u5b66\u4e34\u5e8a\u68c0\u9a8c\u8bca\u65ad\u5b66\u7cfb,\u00a0\u7b49.\u00a0\u9ad8\u901a\u91cf\u6d4b\u5e8f\u6280\u672f\u4e34\u5e8a\u89c4\u8303\u5316\u5e94\u7528\u5317\u4eac\u4e13\u5bb6\u5171\u8bc6(\u7b2c\u4e00\u7248\u80bf\u7624\u90e8\u5206)[J].\u00a0\u4e2d\u534e\u533b\u5b66\u6742\u5fd7,\u00a02020,\u00a0100(9):648-659.\u00a0DOI:\u00a010.3760\/cma.j.issn.0376-2491.2020.09.003.<\/p>\n
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