\n![\"RmFicvQBAkgDEsUia5jbfibMgeRrNibH1ns0NaxVdCMqRl9Bcn0geKXKbn4CByInShB9u6lDPnKmK1nhKxqqiaRaUzQ\"\/](\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgDEsUia5jbfibMgeRrNibH1ns0NaxVdCMqRl9Bcn0geKXKbn4CByInShB9u6lDPnKmK1nhKxqqiaRaUzQ.gif\")
<\/figure><\/div>\n\n<\/div>\n
<\/figure><\/div>\n\n<\/div>\n\u5173\u952e\u5b57\uff1a\u57fa\u56e0\u7f16\u8f91\u52a8\u7269 \u80bf\u7624\u57fa\u56e0\u68c0\u6d4b\u8bd5\u5242\u76d2<\/div>\n
\u514d\u75ab\u6cbb\u7597\u00a0\u00a0\u65b0\u533b\u6539\u00a0 \u5927Panel\u00a0 \u9776\u5411\u836f\u00a0\u00a0<\/div>\n
\u57fa\u56e0\u7597\u6cd5\u00a0 \u5206\u5b50\u68c0\u6d4b\u6307\u5357<\/div>\n
\u9605\u8bfb\u7528\u65f6\uff1a\u7ea66\u5206\u949f<\/div>\n
\u5bfc\u8bed<\/div>\n
\u7ee7\u57fa\u56e0\u6167\u53d1\u5e03\u57fa\u56e0\u884c\u4e1a2017\u5e74\u5ea6\u76d8\u70b9\u6295\u878d\u8d44\u7bc7\uff08\u8be6\u60c5<\/a>\uff09\u3001\u6280\u672f\u7bc7\uff08\u8be6\u60c5<\/a>\uff09\u548c\u4ea7\u4e1a\u7bc7\uff08\u8be6\u60c5<\/a>\uff09\u540e\uff0c\u8fd9\u91cc\u4e3a\u5e74\u5ea6\u653f\u7b56\u76d8\u70b9\u7bc7\uff0c\u540c\u65f6\u9080\u8bf7\u4e86\u4e2d\u65e5\u53cb\u597d\u533b\u9662\u987e\u5927\u592b\uff0c\u4e91\u5065\u5eb7\u603b\u88c1\u91d1\u521a\u535a\u58eb\u548c\u541b\u8054\u8d44\u672c\u6295\u8d44\u603b\u76d1\u5468\u73fa\u8fdb\u884c\u7cbe\u5f69\u70b9\u8bc4\u30022017\u5e74\u7a33\u5b9a\u5f00\u653e\u7684\u653f\u7b56\u548c\u8d44\u672c\u56de\u6696\u52a0\u901f\u4e86\u4ea7\u4e1a\u751f\u6001\u5f62\u6210\uff0c\u4ee5\u57fa\u56e0\u79d1\u6280\u4e3a\u6838\u5fc3\u7684\u6570\u5b57\u5065\u5eb7\u8fc8\u5165\u9ec4\u91d1\u5341\u5e74\uff08\u672c\u6587\u8be6\u7ec6\u7248\u672c\u5c06\u6574\u5408\u5230\u57fa\u56e0\u6167\u76842017\u5e74\u57fa\u56e0\u884c\u4e1a\u62a5\u544a\u4e2d\uff09\u3002<\/div>\n
<\/div>\n
\n\n
\n![\"RmFicvQBAkgCAbF9eGxibicPNgfddTxg7hYZfZ6GXXA2FibJUScSicbWRpcj7nBGvPQ0DKUPcWo6Ec2VDjrR6yMBTGQ\"\/](\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgCAbF9eGxibicPNgfddTxg7hYZfZ6GXXA2FibJUScSicbWRpcj7nBGvPQ0DKUPcWo6Ec2VDjrR6yMBTGQ.png\")
<\/figure><\/div>\n\n
<\/figure><\/div>\n\n\u5212\u91cd\u70b9<\/div>\n
FDA\uff1a\u9881\u5e03\u5173\u4e8e\u57fa\u56e0\u7ec4\u7f16\u8f91\u52a8\u7269\u7684\u6307\u5357<\/div>\n
FDA\uff1a\u6279\u51c6\u8bfa\u534eCAR-T\u7ec6\u80de\u7597\u6cd5\u6b63\u5f0f\u4e0a\u5e02<\/div>\n
\u56fd\u52a1\u9662\uff1a\u5173\u4e8e\u6df1\u5316\u5ba1\u8bc4\u5ba1\u6279\u5236\u5ea6\u6539\u9769\u9f13\u52b1\u836f\u54c1\u533b\u7597\u5668\u68b0\u521b\u65b0\u7684\u610f\u89c1<\/div>\n
FDA\uff1a\u6279\u51c6\u591a\u764c\u79cd\u591a\u57fa\u56e0\u68c0\u6d4bPanel<\/div>\n
FDA\uff1a\u52a0\u901f\u9776\u5411\u836f\u7814\u53d1\u6307\u5357\u8349\u6848<\/div>\n
FDA\uff1a\u6279\u51c6\u7f8e\u56fd\u7684\u9996\u6b3e\u201c\u76f4\u63a5\u7ed9\u836f\u578b\u201d\u57fa\u56e0\u7597\u6cd5<\/div>\n
\u536b\u8ba1\u59d4\uff1a\u611f\u67d3\u6027\u75be\u75c5\u76f8\u5173\u7684\u5206\u5b50\u68c0\u6d4b\u6280\u672f\u6307\u5357\u548c\u5fae\u9635\u5217\u57fa\u56e0\u82af\u7247\u6280\u672f\u89c4\u8303<\/div>\n
\uff08\u6309\u7167\u53d1\u5e03\u65f6\u95f4\u6392\u5e8f\uff09<\/div>\n
\u00a0<\/div>\n
1\u3001FDA\u9881\u5e03\u5173\u4e8e\u57fa\u56e0\u7ec4\u7f16\u8f91\u52a8\u7269\u7684\u6307\u5357<\/div>\n\n
\n![\"RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv4XvreOLibn0wb7icerqufiaDFQTb4VjVaEicScggXTlLXWQXIUslXQ7kgTQ\"\/](\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv4XvreOLibn0wb7icerqufiaDFQTb4VjVaEicScggXTlLXWQXIUslXQ7kgTQ.jpeg\")
<\/figure><\/div>\n\n
<\/figure><\/div>\n\n\u81eaCRISPR \/ Cas9\u57fa\u56e0\u7ec4\u7f16\u8f91\u7cfb\u7edf\u51fa\u73b0\u4ee5\u6765\uff0cFDA\u5bf9\u5982\u4f55\u76d1\u7ba1\u57fa\u56e0\u7ec4\u7f16\u8f91\u7684\u4ea7\u7269\uff0c\u7279\u522b\u662f\u6cbb\u7597\u4ea7\u54c1\uff0c\u4e00\u76f4\u8868\u793a\u6c89\u9ed8\uff0c\u5e76\u6d3e\u4ee3\u8868\u53c2\u52a02015\u5e7412\u6708\u7684\u4eba\u7c7b\u57fa\u56e0\u7f16\u8f91\u56fd\u9645\u5cf0\u4f1a\uff0c\u8d5e\u52a9\u4e86\u201c\u5171\u8bc6\u7814\u7a76\u201d\u30022017\u5e741\u6708\uff0cFDA\u9881\u5e03\u4e00\u4efd\u6307\u5bfc\u610f\u89c1\u8349\u6848\uff08\u8be6\u60c5<\/a>\uff09\uff0c\u52a0\u5f3a\u4e86\u57fa\u56e0\u7ec4\u7f16\u8f91\u52a8\u7269\u7684\u76d1\u7ba1\uff0c\u628a\u57fa\u56e0\u7f16\u8f91\u52a8\u7269\u4f5c\u4e3a\u65b0\u52a8\u7269\u836f\u7269\u8fdb\u884c\u7ba1\u5236[1]\u3002<\/div>\n
\u00a0<\/div>\n
2\u3001\u591a\u4e2a\u56fd\u4ea7\u80bf\u7624\u57fa\u56e0\u68c0\u6d4b\u8bd5\u5242\u76d2\u7533\u8bf7\u83b7\u5f97CFDA\u53d7\u7406<\/div>\n\n
\n![\"RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv4jhhp4k4l8SH3kffc28FXfrbH7l8OpKTRbvFof7FupLWFy3a4qXWLNw\"\/](\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv4jhhp4k4l8SH3kffc28FXfrbH7l8OpKTRbvFof7FupLWFy3a4qXWLNw.jpeg\")
<\/figure><\/div>\n\n
<\/figure><\/div>\n\n\u7ee72016\u5e749\u6708\u4efd\u71c3\u77f3\u533b\u5b66\u7684EGFR\/ALK\/BRAF\/KRAS\u57fa\u56e0\u7a81\u53d8\u68c0\u6d4b\u8bd5\u5242\u76d2\u8fdb\u5165CFDA\u521b\u65b0\u533b\u7597\u5668\u68b0\u7279\u522b\u5ba1\u6279\u7a0b\u5e8f\u540e\uff0c\u81ea2017\u5e743\u6708\u8d77\uff0c\u827e\u5fb7\u751f\u7269\u3001\u8bfa\u79be\u81f4\u6e90\u3001\u4e16\u548c\u57fa\u56e0\u3001\u535a\u5c14\u8bda\uff08\u5317\u4eac\uff09\u3001\u98de\u6714\u751f\u7269\u4e94\u5bb6\u4f01\u4e1a\u7684\u80bf\u7624\u57fa\u56e0\u68c0\u6d4b\u8bd5\u5242\u76d2\u4ea7\u54c1\u9646\u7eed\u83b7\u5f97CFDA\u53d7\u7406\u3002\u8fd9\u91cc\u53ef\u4ee5\u770b\u5230CFDA\u91ca\u653e\u52a0\u901f\u80bf\u7624\u57fa\u56e0\u68c0\u6d4b\u5e02\u573a\u89c4\u8303\u5316\u7ba1\u7406\u7684\u4fe1\u53f7[2]\u3002<\/div>\n
\u00a0<\/div>\n
3\u3001\u591a\u90e8\u59d4\u8054\u5408\u53d1\u5e0332\u5bb6\u56fd\u5bb6\u4e34\u5e8a\u533b\u5b66\u7814\u7a76\u4e2d\u5fc3\u540d\u5355<\/div>\n\n
\n![\"RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv48soweFe0qkcX8j96ZfFZI0GTWsnL7bABv9FSyLtpeu3gScHWnR1G7A\"\/](\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv48soweFe0qkcX8j96ZfFZI0GTWsnL7bABv9FSyLtpeu3gScHWnR1G7A.jpeg\")
<\/figure><\/div>\n\n
<\/figure><\/div>\n\n7\u670822\u65e5\uff0c\u79d1\u6280\u90e8\u3001\u56fd\u5bb6\u536b\u751f\u8ba1\u751f\u59d4\u3001\u4e2d\u592e\u519b\u59d4\u540e\u52e4\u4fdd\u969c\u90e8\u548c\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u8054\u5408\u53d1\u5e03\u300a\u56fd\u5bb6\u4e34\u5e8a\u533b\u5b66\u7814\u7a76\u4e2d\u5fc3\u4e94\u5e74\uff082017-2021\u5e74\uff09\u53d1\u5c55\u89c4\u5212\u300b\u300a\u56fd\u5bb6\u4e34\u5e8a\u533b\u5b66\u7814\u7a76\u4e2d\u5fc3\u7ba1\u7406\u529e\u6cd5\uff082017\u5e74\u4fee\u8ba2\uff09\u300b\u548c\u300a\u56fd\u5bb6\u4e34\u5e8a\u533b\u5b66\u7814\u7a76\u4e2d\u5fc3\u8fd0\u884c\u7ee9\u6548\u8bc4\u4f30\u65b9\u6848\u300b\u3002\u636e\u6089\uff0c\u81ea2012\u5e74\u5f00\u59cb\uff0c\u76f8\u5173\u90e8\u95e8\u7740\u624b\u56fd\u5bb6\u4e34\u5e8a\u533b\u5b66\u7814\u7a76\u4e2d\u5fc3\u7684\u5efa\u8bbe\uff0c\u622a\u81f3\u76ee\u524d\uff0c\u5df2\u5728\u5fc3\u8840\u7ba1\u75be\u75c5\u3001\u795e\u7ecf\u7cfb\u7edf\u75be\u75c5\u3001\u6162\u6027\u80be\u75c5\u7b4911\u4e2a\u75be\u75c5\u9886\u57df\u5efa\u8bbe\u4e8632\u4e2a\u56fd\u5bb6\u4e34\u5e8a\u533b\u5b66\u7814\u7a76\u4e2d\u5fc3\uff0c\u5747\u4f9d\u6258\u5728\u76f8\u5e94\u75be\u75c5\u9632\u63a7\u9886\u57df\u5b9e\u529b\u6700\u5f3a\u3001\u6c34\u5e73\u6700\u9ad8\u7684\u56fd\u5185\u4e09\u7532\u533b\u9662\u3002\u56fd\u5bb6\u7ea7\u4e34\u5e8a\u533b\u5b66\u7814\u7a76\u4e2d\u5fc3\uff0c\u4f5c\u4e3a\u5b9e\u4f53\u96c6\u4e2d\u4e86\u751f\u7269\u6837\u672c\u8d44\u6e90\u7ba1\u7406\uff0c\u52a0\u5f3a\u4e34\u5e8a\u7814\u7a76\u548c\u4e34\u5e8a\u5e94\u7528\u7684\u76f8\u4e92\u8f6c\u5316\uff0c\u7279\u522b\u662f\u5bf9\u4e8e\u5927\u89c4\u6a21\u4eba\u7fa4\u961f\u5217\u7814\u7a76\u7684\u57fa\u56e0\u7ec4\u4fe1\u606f\u548c\u4e34\u5e8a\u8868\u578b\u4fe1\u606f\u7684\u6570\u636e\u5e73\u53f0\u5efa\u8bbe\u3001\u5206\u6790\u5e73\u53f0\u5efa\u8bbe\u548c\u591a\u4e2d\u5fc3\u7ba1\u7406\u5e73\u53f0\u6709\u7740\u91cd\u8981\u7684\u610f\u4e49[3]\u3002<\/div>\n
\u00a0<\/div>\n
4\u3001FDA\u6279\u51c6\u8bfa\u534eCAR-T\u7ec6\u80de\u7597\u6cd5\u4e0a\u5e02\u00a0<\/div>\n\n
\n![\"RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv44D8h0LAvMGewm8z8lFGgI8znLHHUMOWxe2gbibwXlNuPt4RWI68Ehiaw\"\/](\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv44D8h0LAvMGewm8z8lFGgI8znLHHUMOWxe2gbibwXlNuPt4RWI68Ehiaw.jpeg\")
<\/figure><\/div>\n\n
<\/figure><\/div>\n\n8\u670830\u65e5\uff0cFDA\u5ba3\u5e03\u6279\u51c6\u8bfa\u534eCAR-T\u7ec6\u80de\u7597\u6cd5\u6b63\u5f0f\u4e0a\u5e02\uff0c\u7528\u4e8e\u6cbb\u7597\u590d\u53d1\u6027\u6216\u96be\u6cbb\u6027\u513f\u7ae5\u3001\u9752\u5c11\u5e74B-\u7ec6\u80de\u6025\u6027\u6dcb\u5df4\u7ec6\u80de\u767d\u8840\u75c5\uff0c\u5176\u5546\u54c1\u540d\u4e3aKymriah(tisagenlecleucel)\u3002FDA\u79f0\u5176\u4e3a\u201c\u8fd9\u662f\u4e00\u9879\u5386\u53f2\u6027\u7684\u51b3\u8bae\uff0c\u4f7f\u5f97\u7f8e\u56fd\u7684\u7b2c\u4e00\u79cd\u57fa\u56e0\u6cbb\u7597\u65b9\u6cd5\u5e94\u7528\u5728\u6cbb\u7597\u764c\u75c7\u4ee5\u53ca\u5176\u4ed6\u4e25\u91cd\u548c\u5371\u53ca\u751f\u547d\u7684\u75be\u75c5\u4e0a\u201d[4]\u3002\u4ee5CAR-T\u548cPD-1\/PD-L1\u4e3a\u4ee3\u8868\u7684\u514d\u75ab\u6cbb\u7597\u5728\u7597\u6548\u8bc4\u4f30\u4e0a\uff0c\u57fa\u56e0\u7a81\u53d8\u8d1f\u8377\uff08TMB\uff09\u548c\u5fae\u536b\u661f\u4e0d\u7a33\u5b9a\u6027\uff08MSI\uff09\u662f\u6700\u4f73\u7684\u751f\u7269\u6807\u8bb0\u4e4b\u4e00\uff0c\u56fd\u5185\u9646\u7eed\u6709\u836f\u4f01\u5f00\u529e\u57fa\u56e0\u68c0\u6d4b\u5b50\u516c\u53f8\uff0c\u5c06\u514d\u75ab\u6cbb\u7597\u836f\u7269\u7814\u53d1\u548c\u57fa\u56e0\u5927\u6570\u636e\u7ed3\u5408\u5c06\u662f\u4e0b\u6e38\u4e3b\u8981\u5e94\u7528\u548c\u63a5\u76d8\u4e4b\u4e00\u3002<\/div>\n
\u00a0<\/div>\n
5\u3001\u56fd\u52a1\u9662\u53d1\u5e03\u5173\u4e8e\u836f\u54c1\u533b\u7597\u5668\u68b0\u521b\u65b0\u7684\u653f\u7b56<\/div>\n\n
\n![\"RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv4DGln1IibdTuXZRzof99t3hntkic0OCkZP9XoknZWtqByIU2NDq3cmdbw\"\/](\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv4DGln1IibdTuXZRzof99t3hntkic0OCkZP9XoknZWtqByIU2NDq3cmdbw.jpeg\")
<\/figure><\/div>\n\n
<\/figure><\/div>\n\n2017\u5e7410\u67088\u65e5\uff0c\u4e2d\u5171\u4e2d\u592e\u529e\u516c\u5385\u3001\u56fd\u52a1\u9662\u529e\u516c\u5385\u5370\u53d1\u4e86\u300a\u5173\u4e8e\u6df1\u5316\u5ba1\u8bc4\u5ba1\u6279\u5236\u5ea6\u6539\u9769\u9f13\u52b1\u836f\u54c1\u533b\u7597\u5668\u68b0\u521b\u65b0\u7684\u610f\u89c1\u300b\uff08\u4fd7\u79f0\u201c\u65b0\u533b\u653936\u6761\u201d\uff09\u3002\u201c\u65b0\u533b\u653936\u6761\u201d\u4ece\u6539\u9769\u4e34\u5e8a\u8bd5\u9a8c\u7ba1\u7406\u3001\u52a0\u5feb\u4e0a\u5e02\u5ba1\u8bc4\u5ba1\u6279\uff0c\u4fc3\u8fdb\u836f\u54c1\u521b\u65b0\u548c\u4eff\u5236\u836f\u53d1\u5c55\u3001\u52a0\u5f3a\u836f\u54c1\u533b\u7597\u5668\u68b0\u5168\u751f\u547d\u5468\u671f\u7684\u7ba1\u7406\u3001\u63d0\u5347\u6280\u672f\u652f\u6491\u80fd\u529b\u548c\u52a0\u5f3a\u7ec4\u7ec7\u7ba1\u7406\u7b49\u65b9\u9762\u63a8\u51fa\u4e86\u76f8\u5f53\u5927\u7a0b\u5ea6\u7684\u521b\u65b0\u6027\u4e3e\u63aa\u3002\u57fa\u56e0\u6167\u4e5f\u9080\u8bf7\u4e86\u5341\u4f4d\u884c\u4e1a\u4e13\u5bb6\u5bf9\u6b64\u8fdb\u884c\u4e86\u70b9\u8bc4\uff08\u8be6\u60c5<\/a>\uff09\u3002\u4e13\u5bb6\u8c08\u5230\uff0c\u5728\u7cbe\u51c6\u533b\u7597\u65f6\u4ee3\uff0c\u836f\u7269\u4e0e\u4f5c\u4e3a\u4f34\u968f\u8bca\u65ad\u624b\u6bb5\u7684\u5206\u5b50\u68c0\u6d4b\u4f1a\u6709\u5927\u91cf\u7684\u5173\u8054\u6570\u636e\u4ea7\u751f\u4e8e\u4f9d\u636e\u68c0\u6d4b\u7ed3\u679c\u524d\u77bb\u6027\u7b5b\u9009\u4eba\u7fa4\u7684\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\uff0c\u5c06\u6709\u8d8a\u6765\u8d8a\u591a\u7684basket trials, umbrella trials\u7b49\u8de8\u8d8a\u68c0\u6d4b\u5e73\u53f0\u3001\u8de8\u8d8a\u836f\u7269\u3001\u8de8\u8d8a\u764c\u79cd\u7684\u521b\u65b0\u6027\u4e34\u5e8a\u8bd5\u9a8c\u5a92\u4f53\u79f0\u662f\u201c\u533b\u6539\u7684\u6625\u5929\u201d\uff0c\u4e13\u5bb6\u79f0\u201c\u4e00\u76f4\u4ee5\u6765\u7684\u547c\u5401\u5f97\u5230\u4f53\u73b0\u201d\u3002<\/div>\n
\u00a0<\/div>\n
6\u3001\u591a\u764c\u79cd\u591a\u57fa\u56e0\u68c0\u6d4b\u83b7FDA\u6279\u51c6<\/div>\n\n
\n![\"RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv4iaP5S34g6DmJbtnhgCxjCIwqICC5fId9mk4jZGtPj9Msic5pOYNBu4gg\"\/](\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv4iaP5S34g6DmJbtnhgCxjCIwqICC5fId9mk4jZGtPj9Msic5pOYNBu4gg.jpeg\")
<\/figure><\/div>\n\n
<\/figure><\/div>\n\n2017\u5e7411\u6708\uff0c\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u54c1\u7ba1\u7406\u5c40\uff08FDA\uff09\u3001\u533b\u7597\u4fdd\u9669\u548c\u533b\u7597\u8865\u52a9\u670d\u52a1\u4e2d\u5fc3\uff08CMS\uff09\u540c\u65f6\u6279\u51c6\u4e86\u9996\u4e2a\u7a81\u7834\u6027\u7684\u591a\u764c\u79cd\u4f34\u968f\u8bca\u65ad\u57fa\u56e0\u68c0\u6d4b\u5e73\u53f0\uff0c\u7531\u7f8e\u56fd\u77e5\u540d\u80bf\u7624\u57fa\u56e0\u68c0\u6d4b\u4f01\u4e1aFoundation Medicine\u5f00\u53d1\uff0c\u8986\u76d6324\u4e2a\u57fa\u56e0\u548c\u4e24\u4e2a\u57fa\u56e0\u7ec4\u6807\u8bb0\u76f8\u5173\u7684\u5b9e\u4f53\u7624[5]\u3002\u76f8\u5bf9\u4e8e11\u6708\u4e2d\u65ecFDA\u5bf9MSK\u764c\u75c7\u4e2d\u5fc3\u7684468\u4e2a\u57fa\u56e0\u7684510k\u7684\u68c0\u6d4b\uff0c\u8fd9\u6b21\u662f\u7b2c\u4e00\u4e2a\u7a81\u7834\u6027\u7684\u591a\u57fa\u56e0\u591a\u764c\u75c7\u7684\u4f34\u968f\u8bca\u65adLDT\u68c0\u6d4b\u65b9\u6cd5\u83b7\u6279[6]\u3002<\/div>\n
\u00a0<\/div>\n
7\u3001AMP\u548cCAP\u53d1\u5e03NGS\u751f\u7269\u4fe1\u606f\u6d41\u7a0b\u9a8c\u8bc1\u6807\u51c6\u548c\u6307\u5357\u00a0<\/div>\n\n
\n![\"RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv4CeEGvhgh5iaWFBRPtZiadC6a25JzujO0XTZodpRcFrXDWJAqXib608ibGw\"\/](\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv4CeEGvhgh5iaWFBRPtZiadC6a25JzujO0XTZodpRcFrXDWJAqXib608ibGw.jpeg\")
<\/figure><\/div>\n\n
<\/figure><\/div>\n\n2017\u5e7411\u6708\uff0c\u7f8e\u56fd\u5206\u5b50\u75c5\u7406\u5b66\u4f1a\uff08AMP\uff09\u4e0e\u7f8e\u56fd\u75c5\u7406\u5b66\u4f1a\uff08CAP\uff09\u7ec4\u7ec7\u76f8\u5173\u65b9\u5236\u5b9a\u5e76\u53d1\u5e03\u4e86\u300aNGS\u751f\u7269\u4fe1\u606f\u6d41\u7a0b\u9a8c\u8bc1\u6807\u51c6\u548c\u6307\u5357\u300b\uff0c\u786e\u5b9a\u4e86\u57fa\u56e0\u6d4b\u5e8f\u7684\u751f\u7269\u4fe1\u606f\u6d41\u7a0b\u5728\u4e34\u5e8a\u7684\u89c4\u8303\uff0c\u660e\u786e\u751f\u7269\u4fe1\u606f\u7684\u57fa\u672c\u5b9a\u4e49\u3001\u6d41\u7a0b\u548c\u6b65\u9aa4[7]\u3002<\/div>\n
\u00a0<\/div>\n
8\u3001FDA\u516c\u5e03\u52a0\u901f\u9776\u5411\u836f\u7814\u53d1\u6307\u5357\u8349\u6848\u00a0<\/div>\n\n
\n![\"RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv4fk9icTEuOxu8G2C7oquZAcviaPj94ZzRhIsZcT40y8ibUY4DVOustWLrA\"\/](\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv4fk9icTEuOxu8G2C7oquZAcviaPj94ZzRhIsZcT40y8ibUY4DVOustWLrA.jpeg\")
<\/figure><\/div>\n\n
<\/figure><\/div>\n\n2017\u5e7412\u6708\uff0cFDA\u516c\u5e03\u4e24\u9879\u6307\u5357\u8349\u6848\uff0c\u6982\u8ff0\u4e86\u52a0\u901f\u5f00\u53d1\u9776\u5411\u836f\u7269\u53ca\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u4f53\u5916\u8bca\u65ad\u5668\u68b0\u7684\u76d1\u7ba1\u8981\u6c42\u3002\u5176\u4e2d\uff0c\u63a2\u8ba8\u4e86\u5728\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u4ee5\u5206\u5b50\u6807\u8bb0\u7269\u5bf9\u60a3\u8005\u5206\u7ec4\uff0c\u5e76\u8bc4\u4f30\u836f\u7269\u7684\u7597\u6548\u53ca\u98ce\u9669[8]\uff0c\u540c\u65f6\u5bf9\u6cbb\u7597\u6027\u7684\u4f53\u5916\u8bca\u65ad\u533b\u7597\u5668\u68b0\u63d0\u51fa\u4e86\u76d1\u7ba1\u7684\u539f\u5219\u548c\u8981\u6c42[9]\u3002<\/div>\n
\u00a0<\/div>\n
9\u3001FDA\u6279\u51c6\u7f8e\u56fd\u9996\u6b3e\u201c\u76f4\u63a5\u7ed9\u836f\u578b\u201d\u57fa\u56e0\u7597\u6cd5\u00a0<\/div>\n\n
\n![\"RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv4Tat2Gb1zpVmWKoiaZicHAGeVDLGdlLhOibzbQylR6QqRdGRobWIHdzhzw\"\/](\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv4Tat2Gb1zpVmWKoiaZicHAGeVDLGdlLhOibzbQylR6QqRdGRobWIHdzhzw.jpeg\")
<\/figure><\/div>\n\n
<\/figure><\/div>\n\n2017\u5e7412\u670820\u65e5\uff0cFDA\u5ba3\u5e03\u6279\u51c6Spark Therapeutics\u7684\u57fa\u56e0\u7597\u6cd5Luxturna\u4e0a\u5e02\u3002Luxturna\u7528\u4e8e\u6cbb\u7597\u60a3\u6709\u9057\u4f20\u6027\u89c6\u7f51\u819c\u8425\u517b\u4e0d\u826f\u7684\u513f\u7ae5\u548c\u6210\u4eba\u60a3\u8005\uff0c\u8fd9\u7c7b\u75be\u75c5\u90e8\u5206\u662f\u7531\u4e8eRPE65\u57fa\u56e0\u7a81\u53d8\u5f15\u8d77RPE65\u9176\u6c34\u5e73\u4e0b\u964d\u6216\u7f3a\u5931\u4ece\u800c\u4f7f\u60a3\u8005\u7684\u89c6\u529b\u53d7\u635f\u751a\u81f3\u5931\u660e\u3002Luxturna\u7597\u6cd5\u5229\u7528\u817a\u76f8\u5173\u75c5\u6bd2\u6280\u672f\uff0c\u80fd\u5c06\u5065\u5eb7\u7684RPE65\u57fa\u56e0\u76f4\u63a5\u5f15\u5165\u5230\u89c6\u7f51\u819c\u7ec6\u80de\u4e2d\uff0c\u8ba9\u5b83\u4eec\u4ea7\u751f\u6b63\u5e38\u7684RPE65\u9176\uff0c\u6062\u590d\u60a3\u8005\u7684\u89c6\u529b\u3002\u5728\u670941\u540d\u60a3\u8005\u53c2\u4e0e\u7684\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\uff0c\u8fd9\u4e00\u7597\u6cd5\u7684\u6548\u679c\u4e0e\u5b89\u5168\u6027\u5f97\u5230\u4e86\u6709\u6548\u7684\u9a8c\u8bc1[10]\u3002<\/div>\n
\u00a0<\/div>\n
10\u3001\u536b\u8ba1\u59d4\u53d1\u5e03\u611f\u67d3\u6027\u75be\u75c5\u5206\u5b50\u68c0\u6d4b\u6307\u5357\u548c\u57fa\u56e0\u82af\u7247\u89c4\u8303<\/div>\n\n
\n![\"?wx_fmt=jpeg\"\/](\"https:\/\/mmbiz.qpic.cn\/mmbiz_jpg\/RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv4LJBKPGjtLbgFzCbqSib68WqJ1H4hX8qqicoqG7TW7f1np3vTnFSAvc4A\/?wx_fmt=jpeg\")
<\/figure><\/div>\n\n<\/div>\n
2017\u5e7412\u67085\u65e5\uff0c\u56fd\u5bb6\u536b\u751f\u8ba1\u751f\u59d4\u529e\u516c\u5385\u4e8e\u53d1\u5e03\u4e86\u300a\u611f\u67d3\u6027\u75be\u75c5\u76f8\u5173\u4e2a\u4f53\u5316\u533b\u5b66\u5206\u5b50\u68c0\u6d4b\u6280\u672f\u6307\u5357\u300b\u548c\u300a\u4e2a\u4f53\u5316\u533b\u5b66\u68c0\u6d4b\u5fae\u9635\u5217\u57fa\u56e0\u82af\u7247\u6280\u672f\u89c4\u8303\u300b\u7684\u901a\u77e5\u3002\u300a\u611f\u67d3\u6027\u75be\u75c5\u76f8\u5173\u4e2a\u4f53\u5316\u533b\u5b66\u5206\u5b50\u68c0\u6d4b\u6280\u672f\u6307\u5357\u300b\u4e3b\u8981\u9002\u7528\u4e8e\u5f00\u5c55\u4e2a\u4f53\u5316\u533b\u5b66\u5206\u5b50\u68c0\u6d4b\u7684\u533b\u7597\u673a\u6784\u4e34\u5e8a\u68c0\u9a8c\u5b9e\u9a8c\u5ba4\uff0c\u540c\u65f6\u4f9b\u4ece\u4e8b\u611f\u67d3\u6027\u75be\u75c5\u8bca\u6cbb\u7684\u4e34\u5e8a\u533b\u5e08\u53c2\u8003\u3002\u300a\u4e2a\u4f53\u5316\u533b\u5b66\u68c0\u6d4b\u5fae\u9635\u5217\u57fa\u56e0\u82af\u7247\u6280\u672f\u89c4\u8303\u300b\u9002\u7528\u4e8e\u533b\u7597\u673a\u6784\u5f00\u5c55\u5fae\u9635\u5217\u57fa\u56e0\u82af\u7247\u4e2a\u4f53\u5316\u533b\u5b66\u68c0\u6d4b\u670d\u52a1\u3002\u7531\u5168\u56fd\u751f\u7269\u82af\u7247\u6807\u51c6\u5316\u6280\u672f\u59d4\u5458\u4f1a\uff08SAC\/TC 421\uff09\u63d0\u51fa[11]\u3002<\/div>\n
<\/div>\n
<\/div>\n
\u5927\u5496\u5bc4\u8bed<\/div>\n
<\/div>\n
<\/div>\n
\n\n
\n![\"RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv4SUqjhjvNt2b6RjfqUgMw0nuvzzbQ7w1Cic9JiaTibnU99ILoz1IibOicrpA\"\/](\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv4SUqjhjvNt2b6RjfqUgMw0nuvzzbQ7w1Cic9JiaTibnU99ILoz1IibOicrpA.jpeg\")
<\/figure><\/div>\n\n
<\/figure><\/div>\n\n\u987e\u536b\u7ea2 \u535a\u58eb\uff08\u987e\u5927\u592b\uff09<\/div>\n
\u4e2d\u65e5\u53cb\u597d\u533b\u9662\u8fd0\u52a8\u969c\u788d\u4e0e\u795e\u7ecf\u9057\u4f20\u7814\u7a76\u4e2d\u5fc3\u8d1f\u8d23\u4eba<\/div>\n
CHPO\u603b\u534f\u8c03\u4eba<\/div>\n
\u57fa\u56e0\u884c\u4e1a\u7684\u53d1\u5c55\u5bf9\u4e8e\u7cbe\u51c6\u533b\u7597\u81f3\u5173\u91cd\u8981\uff0c\u4f5c\u4e3a\u4e00\u4e2a\u4e34\u5e8a\u9057\u4f20\u533b\u751f\uff0c\u8fd9\u4e9b\u5e74\u770b\u8fc7\u5f88\u591a\u9057\u4f20\u75c5\u60a3\u8005\uff0c\u4f53\u4f1a\u6df1\u523b\u3002\u57fa\u56e0\u4f5c\u4e3a\u5185\u56e0\uff0c\u4e0e\u5185\u5916\u73af\u5883\u56e0\u7d20\u7684\u5916\u56e0\u76f8\u4e92\u4f5c\u7528\uff0c\u5171\u540c\u51b3\u5b9a\u4e2a\u4f53\u7684\u751f\u547d\u72b6\u6001\u3002\u57fa\u56e0\u79d1\u6280\u7684\u8fc5\u731b\u53d1\u5c55\uff0c\u4f7f\u5f97\u4eba\u7c7b\u5bf9\u4e8e\u81ea\u8eab\u7684\u8ba4\u8bc6\u98de\u901f\u63d0\u9ad8\u3002\u5728\u9057\u4f20\u75c5\u7684\u8bca\u65ad\u548c\u51fa\u751f\u7f3a\u9677\u5e72\u9884\u3001\u80bf\u7624\u7684\u8bca\u65ad\u548c\u6cbb\u7597\u3001\u6162\u6027\u75c5\u7684\u805a\u7c7b\u5206\u5c42\u548c\u6cbb\u7597\u3001\u5408\u7406\u7528\u836f\u3001\u75be\u75c5\u98ce\u9669\u8bc4\u4f30\u548c\u5065\u5eb7\u54a8\u8be2\u7ba1\u7406\u7b49\u65b9\u9762\uff0c\u57fa\u56e0\u7814\u7a76\u548c\u68c0\u6d4b\u90fd\u662f\u51b3\u5b9a\u6027\u7684\u73af\u8282\u3002\u5728\u8ba4\u8bc6\u57fa\u56e0\u7684\u57fa\u7840\u4e0a\uff0c\u6539\u53d8\u57fa\u56e0\uff0c\u6cbb\u7597\u75be\u75c5\uff0c\u662f\u5e7f\u5927\u9057\u4f20\u75c5\u60a3\u8005\u957f\u4e45\u7684\u671f\u671b\u3002<\/div>\n
\u00a0<\/div>\n
\u79d1\u6280\u7684\u53d1\u5c55\u597d\u50cf\u5343\u91cc\u9a6c\u4e00\u6837\uff0c\u9700\u8981\u66f4\u597d\u5730\u628a\u63e1\u65b9\u5411\u3002\u9057\u4f20\u54a8\u8be2\u548c\u533b\u5b66\u5e72\u9884\u7684\u57fa\u672c\u539f\u5219\u662f\uff1a\u6709\u5229\u65e0\u5bb3\uff0c\u5065\u5eb7\u54a8\u8be2\u4e5f\u5e94\u5982\u6b64\u3002\u5982\u4f55\u8ba9\u57fa\u56e0\u79d1\u6280\u7684\u53d1\u5c55\u66f4\u597d\u5730\u63a8\u52a8\u533b\u7597\u5065\u5eb7\u4e8b\u4e1a\u548c\u793e\u4f1a\u7684\u8fdb\u6b65\uff0c\u9700\u8981\u5404\u65b9\u5171\u540c\u5173\u6ce8\u548c\u52aa\u529b\u3002\u5b9e\u4e8b\u6c42\u662f\u3001\u5207\u5b9e\u53ef\u884c\u7684\u653f\u7b56\u7684\u5236\u5b9a\u548c\u53ca\u65f6\u53d1\u5e03\u5bf9\u4e8e\u884c\u4e1a\u7684\u89c4\u8303\u5341\u5206\u91cd\u8981\uff0c\u5c06\u4fc3\u8fdb\u826f\u597d\u751f\u6001\u7684\u5efa\u7acb\uff0c\u63a8\u52a8\u57fa\u56e0\u79d1\u6280\u8fdb\u6b65\u65e9\u65e5\u60e0\u53ca\u60a3\u8005\u548c\u793e\u4f1a\u516c\u4f17\u3002<\/div>\n\n
\n![\"RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv4LnZLgEgcT6oCRpC5LrcGrJJR8Lia8AzJJpEozibzyYValqMYHSsiaU9Eg\"\/](\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv4LnZLgEgcT6oCRpC5LrcGrJJR8Lia8AzJJpEozibzyYValqMYHSsiaU9Eg.jpeg\")
<\/figure><\/div>\n\n
<\/figure><\/div>\n\n\u91d1\u521a \u535a\u58eb<\/div>\n
\u56fd\u5bb6\u201c\u5343\u4eba\u8ba1\u5212\u201d\u4e13\u5bb6<\/div>\n
\u4e91\u5065\u5eb7\u57fa\u56e0\u79d1\u6280\uff08\u4e0a\u6d77\uff09\u6709\u9650\u516c\u53f8\u603b\u88c1\/\u521b\u59cb\u4eba<\/div>\n
2017\u5e74\uff0c\u57fa\u56e0\u7f16\u8f91\u3001CAR-T\u3001Luxturna\u57fa\u56e0\u7597\u6cd5\u7b49\u6280\u672f\u90fd\u7528\u5b9e\u9645\u6848\u4f8b\u8bc1\u660e\u4e86\u5b83\u4eec\u5353\u8d8a\u7684\u4e34\u5e8a\u6548\u679c\uff0c\u8d8a\u53d1\u5c55\u793a\u4e86\u57fa\u56e0\u884c\u4e1a\u5176\u5149\u660e\u7684\u524d\u666f\u3002\u7279\u522b\u662f\u5e74\u5e95\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u5ba3\u5e03\u6279\u51c6MSK\u7684\u80bf\u7624\u591a\u764c\u79cdMSK-IMPACT\u548c\u6cdb\u80bf\u7624\u68c0\u6d4b\u4ea7\u54c1FoundationOne CDx\u4e24\u6b3e\u4ea7\u54c1\uff0c\u7ed92017\u5e74\u7684NGS\u884c\u4e1a\u753b\u4e0a\u4e86\u4e00\u4e2a\u5b8c\u7f8e\u7684\u53e5\u53f7\uff0c\u5c55\u793a\u4e86\u57fa\u56e0\u68c0\u6d4b\u5168\u9762\u5411\u591a\u764c\u79cd\u591a\u9776\u70b9\u68c0\u6d4b\u7684\u53d1\u5c55\u8d8b\u52bf\uff0c\u5168\u9762\u9769\u65b0\u75c5\u7406\u68c0\u6d4b\u6280\u672f\u3002\u6b64\u5916\u4e2d\u56fd\u533b\u7597\u5668\u68b0\u6280\u672f\u8bc4\u5ba1\u5b98\u65b9\u4e5f\u53ca\u65f6\u7ed9\u51fa\u4e86\u5168\u9762\u89e3\u8bfb\uff0c\u8868\u660e\u4e2d\u56fd\u4f1a\u968f\u65f6\u8ddf\u968fFDA\u7684\u811a\u6b65\u3002\u4e91\u5065\u5eb7\u5728\u4eca\u5e74\u4e09\u6708\u5c31\u5f00\u59cb\u7814\u53d1\u591a\u764c\u79cdpanel\u3002\u4e5d\u6708\u63a8\u51fa565\u57fa\u56e0\u5305\u6db5\u6240\u6709FoundationOne CDx\u7684\u57fa\u56e0\uff0c\u52a9\u529b\u4e2d\u56fd\u4e34\u5e8a\u5206\u5b50\u8bca\u65ad\uff0c\u4fc3\u8fdb\u5206\u5b50\u75c5\u7406\u5168\u9762\u843d\u5730\u5230\u5404\u7ea7\u533b\u9662\u3002\u5f53\u7136\u884c\u4e1a\u5185\u4e5f\u5b58\u5728\u826f\u83a0\u4e0d\u9f50\u7684\u4e71\u8c61\uff0c\u4f46\u76f8\u4fe1\u968f\u7740\u884c\u4e1a\u7684\u53d1\u5c55\uff0c\u76d1\u7ba1\u7684\u52a0\u5f3a\uff0c\u672a\u6765\u4e00\u5e74\u57fa\u56e0\u884c\u4e1a\u4f9d\u65e7\u593a\u76ee\uff01<\/div>\n
\u00a0<\/div>\n
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\n![\"RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv4azyysWKUnXCf5NPL9WQIXXnRibatoGibvg8S28VPPv7hLrQHG6EibLFQA\"\/](\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgDKYx5cpicwXHDTKQJAXxPv4azyysWKUnXCf5NPL9WQIXXnRibatoGibvg8S28VPPv7hLrQHG6EibLFQA.jpeg\")
<\/figure><\/div>\n\n
<\/figure><\/div>\n\n\u5468\u73fa<\/div>\n
\u541b\u8054\u8d44\u672c\u6295\u8d44\u603b\u76d1<\/div>\n
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\u00a0<\/div>\n
\u7f16\u540e\u8bb0<\/div>\n
\u7eb5\u89c22017\u5e74\u7684\u91cd\u5927\u653f\u7b56\uff0c\u7f8e\u56fdFDA\u5728\u764c\u75c7\u7684\u5206\u5b50\u8bca\u65ad\u3001\u514d\u75ab\u6cbb\u7597\u3001\u9776\u5411\u836f\u65b9\u9762\u52a0\u901f\u4e86\u5ba1\u6279\u6216\u89c4\u8303\u5316\uff1b\u751f\u7269\u4fe1\u606f\u3001\u57fa\u56e0\u6cbb\u7597\u4e5f\u7eb3\u5165\u4e34\u5e8a\u5e94\u7528\u8def\u5f84\u4e2d\uff0c\u5bf9\u4e8e\u57fa\u56e0\u7f16\u8f91\u7b49\u4f26\u7406\u76f8\u5173\u7684\u6280\u672f\u76f8\u5bf9\u614e\u91cd\uff1b\u6574\u4f53\u770b\u4ece\u5e94\u7528\u8303\u56f4\u548c\u4ef7\u503c\u4e0a\u53cd\u5411\u63a8\u52a8\u6280\u672f\u8f6c\u5316\uff0c\u4e0d\u76f2\u76ee\u8ddf\u98ce\u3002\u56fd\u5185\u5728\u7cbe\u51c6\u533b\u7597\u76f8\u5173\u653f\u7b56\uff0c\u4e00\u65b9\u9762\u4ecd\u5728\u76f8\u5bf9\u521d\u6b65\u7684\u57fa\u7840\u653f\u7b56\u73af\u5883\u5efa\u8bbe\u4e2d\uff0c\u533b\u6539\u7684\u8fdb\u4e00\u6b65\u5f00\u653e\u9f13\u821e\u4e86\u884c\u4e1a\uff0c\u800c\u56fd\u5bb6\u7684\u4e34\u5e8a\u533b\u5b66\u7814\u7a76\u4e2d\u5fc3\u548c\u5206\u5b50\u68c0\u6d4b\u6307\u5357\u7b49\u7a0d\u663e\u5f97\u59d7\u59d7\u6765\u8fdf\uff0c\u5927\u56fd\u91cd\u5668\uff0c\u4eba\u53e3\u7ea2\u5229\u60c5\u51b5\u4e0b\uff0c\u6211\u56fd\u7684\u751f\u7269\u6837\u672c\u8d44\u6e90\u9700\u8981\u52a0\u901f\u5efa\u8bbe\u5e73\u53f0\uff0c\u5305\u62ec\u6837\u672c\u7ba1\u7406\u3001\u591a\u7ef4\u6570\u636e\u7ba1\u7406\u3001\u5927\u6570\u636e\u6316\u6398\u548c\u591a\u4e2d\u5fc3\u4e92\u8054\u7b49\uff0c\u8fd9\u91cc\u9700\u8981\u66f4\u591a\u4ece\u4e0a\u5f80\u4e0b\u548c\u4ece\u4e0b\u5f80\u4e0a\u7684\u6c47\u5408\uff0c\u884c\u4e1a\u8054\u76df\/\u5b66\u4f1a\/\u534f\u4f1a\u9700\u8981\u6709\u884c\u4e1a\u62c5\u5f53\uff0c\u627f\u4e0a\u542f\u4e0b\uff0c\u57282018-2020\u5e74\u6293\u4f4f\u6280\u672f\u673a\u9047\u548c\u8d44\u672c\u98ce\u53e3\uff0c\u4fc3\u8fdb\u653f\u4ea7\u5b66\u7814\u8d44\u5a92\u7684\u878d\u5408\u3001\u53d1\u5c55\u548c\u843d\u5730\u3002<\/div>\n
\u00a0<\/div>\n
\u53c2\u8003\u6587\u732e<\/div>\n
1.https:\/\/www.fda.gov\/downloads\/AnimalVeterinary\/GuidanceComplianceEnforcement\/GuidanceforIndustry\/UCM113903.pdf<\/div>\n
2.http:\/\/www.cmde.org.cn<\/div>\n
3.http:\/\/www.geneclub.net.cn\/info\/policy\/4166.html<\/div>\n
4.https:\/\/www.fda.gov\/newsevents\/newsroom\/pressannouncements\/ucm574058.htm<\/div>\n
5.https:\/\/www.fda.gov\/drugs\/informationondrugs\/approveddrugs\/ucm587387.htm<\/div>\n
6.https:\/\/www.accessdata.fda.gov\/cdrh_docs\/reviews\/den170058.pdf<\/div>\n
7.Somak Roy, ChristopherColdren, et.al. Standards and Guidelines for Validating Next-GenerationSequencing Bioinformatics Pipelines, Journal of Molecular Diagnostics, \u00a020(1): 4\u201327 (2017)<\/div>\n
8.https:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM588884.pdf<\/div>\n
9.https:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/UCM589083.pdf<\/div>\n
10.https:\/\/www.fda.gov\/newsevents\/newsroom\/pressannouncements\/ucm589467.htm<\/div>\n
11.http:\/\/www.nhfpc.gov.cn\/yzygj\/s3593\/201712\/44aa5e433ade4cbeaad8a3a8b95a8199.shtml<\/div>\n
\u00a0<\/div>\n
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