{"id":8015,"date":"2022-11-06T22:22:00","date_gmt":"2022-11-06T14:22:00","guid":{"rendered":"https:\/\/www.geneclub.net.cn\/index.php\/2022\/11\/06\/10210299\/"},"modified":"2026-04-01T09:37:44","modified_gmt":"2026-04-01T01:37:44","slug":"10210299","status":"publish","type":"post","link":"https:\/\/www.geneclub.net.cn\/index.php\/2022\/11\/06\/10210299\/","title":{"rendered":"\u4ece\u5065\u5eb7\u4e2d\u56fd\u7684\u4f7f\u547d\uff0c\u770b\u672a\u6765\u4e09\u5e74\u57fa\u56e0\u79d1\u6280\u7684\u4ef7\u503c\u2014\u2014\u4e34\u5e8a\u7bc7"},"content":{"rendered":"
\n
\"RmFicvQBAkgAJeB0ibLRZRiadnhnuJhRWTHEpXFFduu1vnMaG0zlsjsVk0f7Z5sUb6x3Fgl1D1cXPU9fShOCVz3ww\"\/<\/figure><\/div>\n\n

\u8fd1\u671f\u968f\u7740\u5e7f\u5dde\u3001\u4e0a\u6d77\u3001\u676d\u5dde\u7b49\u5730\u8bd5\u70b9\u63a8\u5e7f\u4e34\u5e8aLDT\uff0c\u4e34\u5e8a\u57fa\u56e0\u68c0\u6d4b\u5165\u9662\u518d\u6b21\u88ab\u805a\u7126\u3002\u8fd9\u4e0d\u4ec5\u5173\u4e4e\u6280\u672f\uff0c\u66f4\u662f\u4ee5\u7ec4\u5b66\u94fe\u63a5\u9057\u4f20\u4fe1\u606f\u3001\u8868\u578b\u4fe1\u606f\u548c\u533b\u7597\u4fe1\u606f\uff0c\u4e3a\u201c\u5065\u5eb7\u4e2d\u56fd\u201d\u6253\u4e0b\u771f\u6b63\u7684\u5927\u6570\u636e\u57fa\u7840\u3002\u4ee5\u4e0b\u7ed3\u5408\u300a2022\u57fa\u56e0\u884c\u4e1a\u84dd\u76ae\u4e66\u300b\u8ba8\u8bba\u57fa\u56e0\u79d1\u6280\u5bf9\u4e8e\u533b\u9662\u3001\u533b\u751f\u53ca\u60a3\u8005\u7684\u5e94\u7528\u4ef7\u503c\uff0c\u66f4\u591a\u8be6\u60c5\u89c12023\u5e74\u5c06\u53d1\u5e03\u7684\u57fa\u56e0\u884c\u4e1a\u84dd\u76ae\u4e66\u3002<\/p>\n

\u300a\u201c\u5065\u5eb7\u4e2d\u56fd2030\u201d\u89c4\u5212\u7eb2\u8981\u300b\u5728\u6218\u7565\u4e3b\u9898\u4e2d\u660e\u786e\u63d0\u51fa\uff1a\u201d\u5168\u6c11\u5065\u5eb7\u662f\u5efa\u8bbe\u5065\u5eb7\u4e2d\u56fd\u7684\u6839\u672c\u76ee\u7684\u3002\u7acb\u8db3\u5168\u4eba\u7fa4\u548c\u5168\u751f\u547d\u5468\u671f\u4e24\u4e2a\u7740\u529b\u70b9\uff0c\u63d0\u4f9b\u516c\u5e73\u53ef\u53ca\u3001\u7cfb\u7edf\u8fde\u7eed\u7684\u5065\u5eb7\u670d\u52a1\uff0c\u5b9e\u73b0\u66f4\u9ad8\u6c34\u5e73\u7684\u5168\u6c11\u5065\u5eb7\u3002\u201c<\/p>\n

\u5176\u4e2d\uff0c\u5168\u4eba\u7fa4\u7684\u672c\u8d28\u662f\u666e\u60e0\uff0c\u5168\u751f\u547d\u5468\u671f\u662f\u4fe1\u606f\u5316\uff0c\u8fd9\u4e24\u70b9\u662f\u4ee5\u57fa\u56e0\u5927\u6570\u636e\u4e3a\u6838\u5fc3\u7684\u751f\u547d\u5927\u6570\u636e\u7ec8\u6781\u4ef7\u503c\u3002<\/p>\n

\u5177\u4f53\u7684\uff0c\u4ee5\u4e0b\u4ece\u4e34\u5e8a\u57fa\u56e0\u68c0\u6d4b\u5165\u9662\u3001\u4ef7\u503c\u903b\u8f91\u548c\u672a\u6765\u4ef7\u503c\u6316\u6398\u6765\u8ba8\u8bba\u3002<\/p>\n

 <\/p>\n

\u4e00\u00a0\u00a0\u00a0LDT\u548c\u4e34\u5e8a\u57fa\u56e0\u68c0\u6d4b\u5165\u9662\u7684\u8d8b\u52bf<\/div>\n

\u5728\u8c08\u4e34\u5e8a\u57fa\u56e0\u68c0\u6d4b\u5165\u9662\u4e4b\u524d\uff0c\u6211\u4eec\u9996\u5148\u4e86\u89e3\u4e0bLDT\u3002<\/p>\n

\u76ee\u524d\u5f15\u8d77\u4e1a\u5185\u5e7f\u6cdb\u5173\u6ce8\u7684LDT\uff0c\u6307\u7684\u662f\u5b9e\u9a8c\u5ba4\u81ea\u5efa\u68c0\u6d4b\u65b9\u6cd5\uff0c\u6216\u5b9e\u9a8c\u5ba4\u81ea\u7814\u68c0\u6d4b\u8bd5\u5242\uff08laboratory developed tests\uff0cLDT\uff09\u3002LDT\u5f80\u5f80\u88ab\u62ff\u6765\u4e0e\u72ed\u4e49\u7684IVD\u8bd5\u5242\u76d2\u6765\u5bf9\u6bd4\u3002\u5e7f\u4e49\u4e0a\uff0cLDT\u4e5f\u5c5e\u4e8eIVD\u65b9\u6cd5\u7684\u4e00\u79cd\uff0c\u6839\u636eFDA\u5b98\u7f51\u5b9a\u4e49[1]\uff0cLDT\u662f\u5728\u5355\u4e2a\u5b9e\u9a8c\u5ba4\u5185\u8bbe\u8ba1\u3001\u5236\u9020\u548c\u4f7f\u7528\u7684\u4e00\u79cd\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u3002<\/p>\n

\u6839\u636e\u56fd\u5bb6\u536b\u751f\u5065\u5eb7\u59d4\u4e34\u5e8a\u68c0\u9a8c\u4e2d\u5fc3\u526f\u4e3b\u4efb\u674e\u91d1\u660e\u7684\u516c\u5f00\u4fe1\u606f[2]\uff0cLDT\u5305\u62ec\u4e09\u79cd\uff1a<\/p>\n

\u5b9e\u9a8c\u5ba4\u8d2d\u4e70\u8bd5\u5242\u76d2\u539f\u6750\u6599\uff0c\u81ea\u7814\u81ea\u7528\u8bd5\u5242<\/p>\n

\u5b9e\u9a8c\u5ba4\u8d2d\u4e70\u7ecf\u8fc7\u6279\u51c6\u7684\u5546\u54c1\u8bd5\u5242\uff0c\u5bf9\u8bd5\u5242\u76d2\u7ec4\u4efd\u6216\u64cd\u4f5c\u8fc7\u7a0b\u8fdb\u884c\u4e86\u6539\u53d8<\/p>\n

\u5b9e\u9a8c\u5ba4\u8d2d\u4e70\u672a\u7ecf\u8fc7\u6279\u51c6\u7684\u5546\u54c1\u8bd5\u5242<\/p>\n

LDT\u4e0e\u72ed\u4e49IVD\u7684\u6838\u5fc3\u533a\u522b\u5728\u4e8e\u8bd5\u5242\u7814\u53d1\u53ca\u5236\u9020\u4e3b\u4f53\uff0c\u56e0\u6b64\u6807\u51c6\u5316\u7a0b\u5ea6\u53ca\u76d1\u7ba1\u653f\u7b56\u6709\u6240\u5dee\u522b\u3002<\/p>\n

IVD\u6709\u975e\u5e38\u6210\u719f\u7684\u76d1\u7ba1\u6761\u4ef6\u548c\u4f7f\u7528\u89c4\u8303\uff0cLDT\u8fd8\u5728\u53d1\u5c55\u4e2d\uff0c\u56e0\u4e3a\u5e38\u7528\u4e8e\u91cd\u8981\u7684\u5feb\u901f\u68c0\u6d4b\u573a\u666f\uff0c\u4f8b\u5982\u4f20\u67d3\u75c5\u3001ICU\u3001\u764c\u75c7\u7b49\u60a3\u8005\u68c0\u6d4b\uff0c\u4e14\u56fd\u5185\u5916\u5927\u90e8\u5206\u57fa\u56e0\u68c0\u6d4b\u90fd\u662f\u533b\u7597\u673a\u6784\u91c7\u7528LDT\u65b9\u6cd5\u6765\u5b9e\u65bd\uff0c\u56e0\u6b64\u4e9f\u5f85\u89c4\u8303\u3002<\/p>\n

\u7f8e\u56fd\u5728IVD\u548cLDT\u7684\u76d1\u7ba1\u5236\u5ea6\u4e0a\u8d77\u6b65\u8f83\u65e9\uff0c\u5176\u4e2d\uff0cIVD\u76d1\u7ba1\u8f83\u4e3a\u6210\u719f\u3002\u9996\u5148\u6211\u4eec\u4eceIVD\u7684\u76d1\u7ba1\u53ca\u4ea7\u54c1\u53d1\u5c55\u4e00\u7aa5\u6f14\u5316\u8109\u7edc\u3002<\/p>\n

\u7f8e\u56fd\u5bf9\u4e8eIVD\u7684\u6838\u5fc3\u653f\u7b56\u59cb\u4e8e1976\u5e74\u7684\u8054\u90a6\u98df\u54c1\u3001\u836f\u54c1\u548c\u5316\u5986\u54c1\u533b\u5b66\u4ea7\u54c1\u6cd5\u6848\u4fee\u6b63\u6848\uff08FD&CA\uff09\uff0c\u5bf9IVD\u8fdb\u884c\u4e86\u8be6\u7ec6\u5206\u7c7b\u548c\u9636\u68af\u5316\u76d1\u7ba1\uff08\u6b27\u76df\u57281998\u5e74\u53d1\u5e03\u4e86\u4f53\u5916\u8bca\u65ad\u533b\u5b66\u4ea7\u54c1\u6307\u4ee4[Council Directive 98\/79\/EC]\uff09\u3002\u6211\u56fd\u4e5f\u91c7\u7528\u4e86\u9636\u68af\u5f0f\u65b9\u5f0f\u8fdb\u884c\u76d1\u7ba1\u3002<\/p>\n

\u5206\u7c7bFDA\u5bf9IVD\u76d1\u7ba1\u6211\u56fd\u5bf9IVD\u76d1\u7ba1I\u7c7b\u65e0\u9700\u6279\u51c6\u4ea7\u54c1\u5907\u6848\u7ba1\u7406II\u7c7b\u8fdb\u5165\u5e02\u573a\u524d\u544a\u77e5\u6216510\uff08K\uff09\u8bb8\u53ef\u7701\u7ea7\u836f\u76d1\u90e8\u95e8\u6ce8\u518cIII\u7c7b\u8fdb\u5165\u5e02\u573a\u524d\u6279\u51c6\uff08PMA\uff09\u56fd\u5bb6\u836f\u76d1\u90e8\u95e8\u6ce8\u518c<\/p>\n

\u8868\uff1aIVD\u7684\u76d1\u7ba1\u65b9\u5f0f\uff08\u6765\u6e90\/\u516c\u5f00\u4fe1\u606f\uff1b\u5236\u8868\/\u57fa\u56e0\u6167\uff09<\/p>\n

\u4f34\u968f\u7740\u6280\u672f\u53ca\u76d1\u7ba1\u7684\u9010\u6b65\u6210\u719f\uff0cIVD\u7684\u68c0\u6d4b\u65b9\u5f0f\u4ece\u5355\u57fa\u56e0\u5230\u591a\u57fa\u56e0\u7ec4\u5408\uff08Panel\uff09\uff0c\u68c0\u6d4b\u6280\u672f\u4eceIHC\u3001FISH\u3001PCR\u5230NGS\uff0c\u8fd1\u51e0\u5e74\u53d1\u5c55\u57282016\u5e74\u8fbe\u5230\u91cc\u7a0b\u7891\u3002<\/p>\n

2016\u5e74\uff0cFDA\u6279\u51c6\u4e86\u9996\u4e2a\u6db2\u4f53\u6d3b\u68c0\uff08\u7f57\u6c0f\u8bca\u65ad\u7684Cobas EGFR\u7a81\u53d8\u6d4b\u8bd5V2\uff09\u548c\u9996\u4e2a\u57fa\u4e8eNGS\u7684\u4f34\u968f\u8bca\u65ad\u8bd5\u5242\u76d2\uff08FoundationFocus CDxBRCA\uff09\uff0c2017\u5e74\u6279\u51c6\u4e86\u9996\u4e2a\u80bf\u7624\u57fa\u56e0\u68c0\u6d4b\u5927Panel\uff08MSK-IMPACT\uff09\u3002\u6211\u56fd\u8d77\u6b65\u7565\u665a\uff0c\u4f46\u540e\u52b2\u8f83\u5927\uff0c\u81ea2018\u5e74\u6279\u51c6\u9996\u4e2a\u57fa\u4e8eNGS\u7684\u80bf\u7624\u4f34\u968f\u8bca\u65ad\u8bd5\u5242\u76d2\uff08\u71c3\u77f3\u533b\u5b66\u7684\u4ebaEGFR\/ALK\/BRAF\/KRAS\u57fa\u56e0\u68c0\u6d4b\u8bd5\u5242\u76d2\uff09\u540e\uff0c\u57282018-2020\u5e74\u95f4\u6279\u51c6\u5341\u4f59\u4e2aNGS\u4f34\u968f\u8bca\u65adIVD\uff0c\u4ece\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u62d3\u5c55\u5230\u7ed3\u76f4\u80a0\u764c\u7b49\uff0c\u5e76\u57282020\u5e74\u6279\u51c6\u9996\u4e2a\u764c\u75c7\u57fa\u56e0\u65e9\u7b5b\u4ea7\u54c1\uff08\u8bfa\u8f89\u5065\u5eb7\u7684KRAS\u57fa\u56e0\u7a81\u53d8\u53caBMP3\/NDRG4\u57fa\u56e0\u7532\u57fa\u5316\u548c\u4fbf\u9690\u8840\u8054\u5408\u68c0\u6d4b\u8bd5\u5242\u76d2\uff09\uff0c\u8fd1\u671f\u5173\u4e8e\u4e73\u817a\u764c\u3001\u8180\u80f1\u764c\u3001\u809d\u764c\u7b49\u591a\u4e2a\u764c\u79cdIVD\u4ea7\u54c1\u6b63\u9646\u7eed\u8fdb\u5165\u5e02\u573a\u6216\u5f00\u5c55\u5927\u89c4\u6a21\u4eba\u7fa4\u961f\u5217\u7814\u7a76\u3002<\/p>\n

\u4f46\u662f\uff0c\u9700\u8981\u52a8\u8f84\u6570\u5e74\u3001\u6570\u5343\u4e07\u5143\u6765\u7814\u53d1\u3001\u62a5\u8bc1\u3001\u4e0a\u5e02\u7684IVD\u4ea7\u54c1\u5e76\u4e0d\u80fd\u5b8c\u5168\u6ee1\u8db3\u4e34\u5e8a\u5feb\u901f\u3001\u591a\u65b9\u4f4d\u68c0\u6d4b\u9700\u6c42\uff0c\u56e0\u6b64\u76ee\u524d\u7edd\u5927\u591a\u6570\u57fa\u56e0\u68c0\u6d4b\u662f\u533b\u7597\u673a\u6784\u91c7\u7528LDT\u65b9\u5f0f\u6765\u5b9e\u65bd\u3002<\/p>\n

LDT\u5728\u5168\u7403\u76d1\u7ba1\u65b9\u9762\u8d77\u6b65\u4e0d\u8fc7\u5341\u4f59\u5e74\u3002\u7f8e\u56fd\u7684\u6838\u5fc3\u539f\u5219\u57fa\u4e8e1988\u5e74\u7684\u4e34\u5e8a\u5b9e\u9a8c\u5ba4\u6539\u8fdb\u4fee\u6b63\u6848\uff08CLIA\uff09\u3002\u76f4\u52302010\u5e74FDA\u624d\u6b63\u5f0f\u5b98\u5ba3\u76d1\u7ba1LDT\u7684\u610f\u56fe\uff0c2014\u5e74\u6b63\u5f0f\u53d1\u5e03\u6307\u5bfc\u8349\u6848\u300aLDTs\u76d1\u7ba1\u6846\u67b6\u300b\uff0c\u6536\u96c6\u76f8\u5173\u53c2\u4e0e\u65b9\u7684\u610f\u89c1\u540e\u4e8e2017\u5e74\u53d1\u5e03\u300aLDTs\u8ba8\u8bba\u6587\u4ef6\u300b\u3002\u5176\u4e2d\u89c4\u5b9a\u9664\u975e\u6709\u5fc5\u8981\u4fdd\u62a4\u516c\u4f17\u5065\u5eb7\uff0c\u5426\u5219LDT\u57fa\u672c\u4e0d\u9700\u8981\u9075\u5b88FDA\u76d1\u7ba1\u8981\u6c42\uff0c\u7279\u522b\u7528\u4e8e\u8bca\u65ad\u6cbb\u7597\u7f55\u89c1\u75c5\u7b49\u7279\u5b9a\u7c7b\u578b\u7684\u6700\u65b0\u663e\u8457\u6539\u8fdb\u7684LDT\u4e0d\u53d7FDA\u76d1\u7ba1[3]\u3002<\/p>\n

\u9700\u8981\u7279\u522b\u8bf4\u7684\u662f\uff0c\u9488\u5bf9\u76f4\u63a5\u9762\u5411\u6d88\u8d39\u8005(DTC)\u7684\u57fa\u56e0\u68c0\u6d4b\uff0cFDA\u81ea2013\u5e74\u52a0\u5f3a\u76d1\u7ba1\u3002\u4f46\u81ea2015\u5e74\u9010\u6b65\u6279\u51c6\u4ee523andMe\u4e3a\u4ee3\u8868\u7684\u57fa\u56e0\u68c0\u6d4b\u4f01\u4e1a\u7684DTC\u4ea7\u54c1\uff0c\u8bb8\u53ef\u7684\u4ea7\u54c1\u8986\u76d6\u8303\u56f4\u5feb\u901f\u62d3\u5bbd\uff0c\u4ece\u5355\u4e2a\u75be\u75c5\uff08\u5e03\u9c81\u59c6\u7efc\u5408\u5f81\uff09\u300110\u79cd\u9057\u4f20\u75c5\u57fa\u56e0\u68c0\u6d4b\u3001\u836f\u7269\u57fa\u56e0\u7ec4\u68c0\u6d4b\u62d3\u5c55\u5230\u764c\u75c7\u57fa\u56e0\u68c0\u6d4b\uff08\u4e73\u817a\u764c\u3001\u7ed3\u76f4\u80a0\u764c\u3001\u524d\u5217\u817a\u764c\uff09\uff0c\u4ec5\u7528\u4e863\u5e74\u65f6\u95f4\u3002<\/p>\n

\u6211\u56fd\u7684LDTs\u4ea7\u54c1\u5728\u4e34\u5e8a\u57fa\u56e0\u68c0\u6d4b\u5e94\u7528\u5e7f\u6cdb\uff0c\u5c3d\u7ba1\u76ee\u524d\u8fd8\u672a\u6709\u6b63\u5f0f\u7684\u76d1\u7ba1\u6587\u4ef6\uff0c\u4f46\u81ea2000\u5e74\u5f00\u59cb\u9010\u6b65\u63a2\u7d22\uff0c\u5728\u6700\u8fd1\u4e24\u5e74\u52a0\u5927\u653e\u5f00LDT\u7684\u529b\u5ea6\uff1a<\/p>\n

2000\u5e74\uff0c\u300a\u533b\u7597\u5668\u68b0\u76d1\u7763\u7ba1\u7406\u6761\u4f8b\u300b\uff08\u56fd\u52a1\u9662\u4ee4\u7b2c276\u53f7\uff09\u4e2d\u7b2c\u5341\u6761\u89c4\u5b9a\uff0c\u533b\u7597\u673a\u6784\u6839\u636e\u672c\u5355\u4f4d\u7684\u4e34\u5e8a\u9700\u8981\uff0c\u53ef\u4ee5\u7814\u5236\u533b\u7597\u5668\u68b0\uff0c\u5728\u6267\u4e1a\u533b\u5e08\u6307\u5bfc\u4e0b\u5728\u672c\u5355\u4f4d\u4f7f\u7528\u3002<\/p>\n

2004\u5e74\uff0c\u300a\u533b\u7597\u5668\u68b0\u76d1\u7763\u7ba1\u7406\u6761\u4f8b\u300b\uff08\u56fd\u52a1\u9662\u4ee4\u7b2c650\u53f7\uff09\u5220\u53bb\u4e86\u4ee5\u4e0a\u89c4\u5b9a\uff0c\u4f46\u5e76\u6ca1\u6709\u89c4\u5b9a\u4e0d\u5141\u8bb8\u81ea\u5236\u533b\u7597\u5668\u68b0\u3002<\/p>\n

2021\u5e74\uff0c\u300a\u533b\u7597\u5668\u68b0\u76d1\u7763\u7ba1\u7406\u6761\u4f8b\u300b(\u56fd\u52a1\u9662\u4ee4\u7b2c739\u53f7)\u4e2d\u7b2c\u4e94\u5341\u4e09\u6761\u89c4\u5b9a\uff0c\u5bf9\u56fd\u5185\u5c1a\u65e0\u540c\u54c1\u79cd\u4ea7\u54c1\u4e0a\u5e02\u7684\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\uff0c\u7b26\u5408\u6761\u4ef6\u7684\u533b\u7597\u673a\u6784\u6839\u636e\u672c\u5355\u4f4d\u7684\u4e34\u5e8a\u9700\u8981\uff0c\u53ef\u4ee5\u81ea\u884c\u7814\u5236\uff0c\u5728\u6267\u4e1a\u533b\u5e08\u6307\u5bfc\u4e0b\u5728\u672c\u5355\u4f4d\u5185\u4f7f\u7528\u3002<\/p>\n

2022\u5e745\u67085\u65e5\uff0c\u5e7f\u5dde\u5e02\u4eba\u6c11\u653f\u5e9c\u53d1\u5e03\u300a\u5173\u4e8e\u5370\u53d1\u5e7f\u5dde\u5e02\u6218\u7565\u6027\u65b0\u5174\u4ea7\u4e1a\u53d1\u5c55\u201c\u5341\u56db\u4e94\u201d\u89c4\u5212\u7684\u901a\u77e5\u300b\uff0c\u5728\u5b8c\u5584\u4e34\u5e8a\u7814\u7a76\u5e94\u7528\u65b9\u9762\uff0c\u660e\u786e\u63d0\u51fa\u79ef\u6781\u652f\u6301\u5b9e\u9a8c\u5ba4\u81ea\u5efa\u68c0\u6d4b\u65b9\u6cd5\uff08LDT\uff09\u8bd5\u70b9\uff0c\u6709\u6761\u4ef6\u5141\u8bb8LDT\u9879\u76ee\u670d\u52a1\u4e8e\u4e34\u5e8a\u63a8\u5e7f\u3002<\/p>\n

2022\u5e7410\u67089\u65e5\uff0c\u4e0a\u6d77\u5e02\u6df1\u5316\u533b\u6539\u9886\u5bfc\u5c0f\u7ec4\u529e\u516c\u5ba4\u53d1\u5e03\u300a\u5173\u4e8e\u5f00\u5c55\u4e0a\u6d77\u5e02\u516c\u7acb\u533b\u9662\u9ad8\u8d28\u91cf\u53d1\u5c55\u8bd5\u70b9\u5de5\u4f5c\u7684\u901a\u77e5\u300b\uff0c\u6587\u4ef6\u63d0\u51fa\uff0c\u6709\u6761\u4ef6\u7684\u533b\u9662\u53ef\u6309\u7167\u6709\u5173\u89c4\u5b9a\u5f00\u5c55\u81ea\u884c\u7814\u5236\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u8bd5\u70b9\u3002<\/p>\n

2022\u5e7410\u670815\u65e5\uff0c\u676d\u5dde\u5e02\u4eba\u6c11\u653f\u5e9c\u529e\u516c\u5385\u53d1\u5e03\u300a\u5173\u4e8e\u52a0\u5feb\u751f\u7269\u533b\u836f\u4ea7\u4e1a\u9ad8\u8d28\u91cf\u53d1\u5c55\u82e5\u5e72\u63aa\u65bd\u7684\u901a\u77e5\u300b\uff0c\u6587\u4ef6\u6307\u51fa\uff0c\u79ef\u6781\u652f\u6301\u5b9e\u9a8c\u5ba4\u81ea\u5efa\u68c0\u6d4b\u65b9\u6cd5\uff08LDT\uff09\u8bd5\u70b9\u3002<\/p>\n

\u5f53\u524d\u7684\u57fa\u56e0\u68c0\u6d4b\u6d41\u7a0b\u4ee5\u9662\u5916\u9001\u6837\u4e3a\u4e3b\uff0c\u5728\u7ed3\u679c\u89e3\u8bfb\u3001\u652f\u4ed8\u3001\u8d28\u91cf\u8d28\u63a7\u7b49\u65b9\u9762\u6ca1\u6709\u5efa\u7acb\u5168\u6d41\u7a0b\u7684\u6709\u6548\u6027\u3001\u4fe1\u606f\u6d41\u53ca\u900f\u660e\u5ea6\uff0c\u957f\u671f\u800c\u8a00\u8fd9\u5bf9\u4e8e\u533b\u7597\u670d\u52a1\u548c\u884c\u4e1a\u53d1\u5c55\u57cb\u4e0b\u9690\u60a3\u3002<\/p>\n

LDT\u7684\u8bd5\u70b9\u662f\u63a8\u52a8\u57fa\u56e0\u68c0\u6d4b\u5165\u9662\u7684\u6709\u6548\u5165\u53e3\uff0c\u4e00\u65b9\u9762\u5c06\u57fa\u56e0\u68c0\u6d4b\u4ea7\u54c1\u6709\u6548\u89e6\u8fbe\u60a3\u8005\u53d7\u4f17\uff0c\u5efa\u7acb\u201c\u91c7\u6837–\u68c0\u6d4b–\u89e3\u8bfb–\u5e94\u7528\u201d\u7684\u95ed\u73af\uff1b\u53e6\u4e00\u65b9\u9762\uff0c\u4e5f\u662f\u7763\u4fc3\u7b2c\u4e09\u65b9\u68c0\u6d4b\u673a\u6784\u52a0\u5927\u4ea7\u54c1\u7814\u53d1\u3001\u8d28\u91cf\u63a7\u5236\u5e73\u53f0\u5efa\u8bbe\u4ee5\u53ca\u5408\u89c4\u63a8\u5e7f\u7684\u53ef\u6301\u7eed\u751f\u6001\u4f53\u7cfb\u3002<\/p>\n

\u65e0\u8bba\u662f\u9662\u5916\u9001\u6837\u3001\u5165\u9662\u68c0\u6d4b\u8fd8\u662f\u9662\u4f01\u5171\u5efa\u5b9e\u9a8c\u5ba4\uff0c\u5c3d\u7ba1\u53d1\u5c55\u66f2\u6298\uff0c\u5e02\u573a\u8ba4\u77e5\u6295\u5165\u8fd1\u5341\u5e74\u7684\u6210\u672c\uff0c\u4f46\u4e34\u5e8a\u533b\u751f\u548c\u7b2c\u4e09\u65b9\u68c0\u6d4b\u673a\u6784\u90fd\u5728\u52aa\u529b\u63a2\u7d22\u5c06\u57fa\u56e0\u68c0\u6d4b\u63a8\u5e7f\u81f3\u4e34\u5e8a\u7684\u8bca\u7597\u4e2d\u3002\u4ece\u66f4\u957f\u65f6\u95f4\u3001\u66f4\u5927\u8303\u56f4\u6765\u770b\uff0c\u57fa\u56e0\u79d1\u6280\u5bf9\u4e8e\u201c\u5065\u5eb7\u4e2d\u56fd\u201d\u6218\u7565\u3001\u5bf9\u4e8e\u5065\u5eb7\u53ca\u533b\u836f\u4ea7\u4e1a\u3001\u5bf9\u4e8e\u6c11\u751f\u5065\u5eb7\u670d\u52a1\u5177\u6709\u6838\u5fc3\u6280\u672f\u7684\u6218\u7565\u4ef7\u503c\u3002\u8fd9\u662f\u4e1a\u5185\u5f62\u6210\u7684\u666e\u904d\u5171\u8bc6\u3002<\/p>\n

\u00a0\u4e8c\u00a0\u00a0\u00a0\u57fa\u56e0\u79d1\u6280\u5bf9\u4e8e\u533b\u9662\u3001\u533b\u751f\u53ca\u60a3\u8005\u7684\u4ef7\u503c<\/p>\n

\u56de\u5f52\u5230\u5b9e\u9645\u5e94\u7528\u573a\u666f\u4e2d\uff0c\u57fa\u56e0\u79d1\u6280\u6ee1\u8db3\u533b\u9662\u3001\u533b\u751f\u53ca\u60a3\u8005\u7aef\u7684\u9700\u6c42\uff0c\u4e14\u5176\u4e2d\u7684\u4ef7\u503c\u9700\u8981\u8fdb\u4e00\u6b65\u6316\u6398\u3002<\/p>\n

\u533b\u9662\u7aef\uff1a\u65e9\u57282015\u5e746\u6708\uff0c\u56fd\u5bb6\u513f\u7ae5\u533b\u5b66\u4e2d\u5fc3\u590d\u65e6\u5927\u5b66\u9644\u5c5e\u513f\u79d1\u533b\u9662\u6b63\u5f0f\u6210\u7acb\u201c\u513f\u7ae5\u7cbe\u51c6\u533b\u5b66\u4e2d\u5fc3\u201d\uff0c\u5efa\u8bbe\u65b9\u5411\u5305\u62ec\u513f\u7ae5\u9057\u4f20\/\u7591\u96be\u75c5\u8bca\u6cbb\u4e2d\u5fc3\u7684\u591a\u5b66\u79d1\u521b\u65b0\u56e2\u961f\uff08MDT\uff09\u3001\u57fa\u56e0\u68c0\u6d4b\u5b9e\u9a8c\u5ba4\u53ca\u7cbe\u51c6\u533b\u5b66\u7814\u7a76\u5ba4\u30022022\u5e7410\u6708\uff0c\u56fd\u5bb6\u536b\u751f\u5065\u5eb7\u59d4\u76f4\u5c5e\u533b\u9662\u4e2d\u65e5\u53cb\u597d\u533b\u9662\u4e34\u5e8a\u5b9e\u9a8c\u5ba4\u81ea\u5efa\u9879\u76ee\u4e2d\u5fc3\uff08LDT\uff09\u63ed\u724c\u3002<\/p>\n

\u533b\u751f\u7aef\uff1a2018\u5e74 JCO Precision Oncology \u53d1\u8868\u4e86\u4e00\u98791281\u540d\u5177\u6709\u7f8e\u56fd\u4ee3\u8868\u6027\u7684\u80bf\u7624\u533b\u751f\u8c03\u7814\u62a5\u544a\uff0c\u8868\u660e75.6%\u7684\u80bf\u7624\u533b\u751f\u4f7f\u7528NGS\u68c0\u6d4b\u6765\u6307\u5bfc\u4e34\u5e8a\u6cbb\u7597\u51b3\u7b56[6]\u30022019\u5e74\uff0cCSCO\u80bf\u7624\u751f\u7269\u6807\u5fd7\u7269\u59d4\u5458\u4f1a\u643a\u624b\u71c3\u77f3\u533b\u5b66\u53d1\u5e03\u57fa\u4e8e30\u4e2a\u7701\u5e02\u76841020\u540d\u4e34\u5e8a\u80bf\u7624\u533b\u751f\u7684NGS\u8c03\u7814\u62a5\u544a\uff0c\u53d1\u73b095.4%\u7684\u4e2d\u56fd\u80bf\u7624\u533b\u751f\u613f\u610f\u63a8\u8350\u66f4\u591a\u60a3\u8005\u9009\u62e9NGS\u68c0\u6d4b\u3002<\/p>\n

\u60a3\u8005\u7aef\uff1a\u6839\u636e\u4e2d\u56fd\u7f55\u89c1\u75c5\u8054\u76df\u300a2020 \u5e74\u4e2d\u56fd\u7f55\u89c1\u75c5\u7efc\u5408\u793e\u4f1a\u8c03\u7814\u300b\uff0c\u5728\u53c2\u4e0e\u8c03\u7814 20,804 \u540d\u60a3\u8005\u4e2d\uff0c15.5% \u7684\u60a3\u8005\u9700\u8981\u7ecf\u5386 1-4 \u5e74\u786e\u8bca\uff0c5.6% \u7684\u60a3\u8005\u9700\u8981\u7ecf\u5386 5-20 \u5e74\u65f6\u95f4\u786e\u8bca\uff0c\u5e73\u5747\u9700\u8981 4.26 \u5e74\u624d\u80fd\u5f97\u5230 \u786e\u8bca\u300242% \u7684\u60a3\u8005\u7ecf\u5386\u8fc7\u8bef\u8bca\u3002\u800c\u57fa\u56e0\u68c0\u6d4b\u53ef\u4ee5\u6709\u6548\u52a0\u901f\u8bca\u65ad\uff0c\u63d0\u5347\u533b\u7597\u6ee1\u610f\u5ea6\uff0c\u5e76\u4fc3\u8fdb\u9776\u5411\u6cbb\u7597\u30022018\u5e74\u82f1\u56fd\u5251\u6865\u5927\u5b66\u56e2\u961f\u5728\u77e5\u540d\u7684\u300a\u82f1\u56fd\u533b\u5b66\u6742\u5fd7\u300b\uff08BMJ\uff09\u53d1\u8868\u7814\u7a76\u6210\u679c\uff0c\u57fa\u4e8e319\u4e2a\u5bb6\u5ead\u7814\u7a76\u53d1\u73b0\u5355\u6b21\u8840\u6db2\u5168\u57fa\u56e0\u7ec4\u6d4b\u5e8f\u68c0\u6d4b\u51fa\u7f55\u89c1\u9057\u4f20\u75be\u75c5\u6bd4\u6807\u51c6\u68c0\u6d4b\u591a31%[7]\u3002<\/p>\n

\u7531\u4e8e\u8f6c\u5316\u5e94\u7528\u8def\u7ebf\u8f83\u957f\u3001\u5e02\u573a\u6559\u80b2\u76f8\u5bf9\u532e\u4e4f\uff0c\u4e14\u5728\u76d1\u7ba1\u7aef\u5177\u6709\u4e00\u5b9a\u654f\u611f\u5ea6\uff0c\u57fa\u56e0\u79d1\u6280\u5bf9\u4e8e\u533b\u9662\u3001\u533b\u751f\u53ca\u60a3\u8005\u7684\u4ef7\u503c\u76ee\u524d\u8fd8\u672a\u53d1\u6398\u5230\u5145\u5206\u7a0b\u5ea6\uff0c\u4f46\u5177\u6709\u957f\u671f\u4ef7\u503c\uff0c\u5176\u57fa\u672c\u903b\u8f91\u662f\u4ee5\u57fa\u56e0\u7ec4\u5b66\u94fe\u63a5\u9057\u4f20\u4fe1\u606f\u3001\u8868\u578b\u4fe1\u606f\u548c\u533b\u7597\u4fe1\u606f\uff0c\u8fdb\u800c\u6784\u5efa\u751f\u547d\u5065\u5eb7\u6570\u5b57\u5316\uff0c\u4e3a\u201c\u5065\u5eb7\u4e2d\u56fd\u201d\u6253\u4e0b\u771f\u6b63\u7684\u5927\u6570\u636e\u57fa\u7840\u3002<\/p>\n

\u5728\u533b\u9662\u5c42\u9762\uff0c\u4ece\u957f\u671f\u800c\u8a00\u5728\u8df5\u884c\u201d\u5065\u5eb7\u4e2d\u56fd\u201c\u7684\u521b\u65b0\u533b\u7597\u536b\u751f\u670d\u52a1\u4f9b\u7ed9\u6a21\u5f0f\u4e0a\uff0c\u901a\u8fc7\u57fa\u56e0\u68c0\u6d4b\u6280\u672f\u5e73\u53f0\u5efa\u7acb\u66f4\u4e13\u4e1a\u7684\u533b\u5b66\u68c0\u9a8c\u4e2d\u5fc3\uff0c\u63d0\u9ad8\u5371\u6025\u91cd\u75c7\u3001\u7591\u96be\u75c5\u75c7\u8bca\u7597\u7684\u6548\u7387\uff0c\u5e76\u901a\u8fc7\u57fa\u56e0\u5927\u6570\u636e\u4e2d\u5fc3\u4e3a\u7ebd\u5e26\u4f18\u5316\u533b\u7597\u8d28\u91cf\u7ba1\u7406\u4e0e\u63a7\u5236\u4fe1\u606f\u5316\u5e73\u53f0\uff0c\u5efa\u7acb\u60a3\u8005\u4e2a\u4f53\u53ca\u7fa4\u4f53\u751f\u547d\u5065\u5eb7\u5927\u6570\u636e\u5e73\u53f0\uff0c\u63d0\u5347MDT\u3001\u533b\u7597\u8054\u5408\u4f53\u3001\u533b\u9662\u96c6\u56e2\u7b49\u591a\u79cd\u5206\u5de5\u6a21\u5f0f\u7684\u7c98\u6027\u548c\u534f\u4f5c\u6548\u679c\u3002\u6b64\u5916\uff0c\u901a\u8fc7\u5f15\u8fdbPCR\u4eea\u3001\u6d4b\u5e8f\u4eea\u7b49\u8bbe\u5907\u52a0\u5feb\u533b\u7597\u5668\u68b0\u8f6c\u578b\u5347\u7ea7\uff1b\u57fa\u56e0\u5927\u6570\u636e\u8fd8\u80fd\u5c06\u4e34\u5e8a\u8bca\u7597\u548c\u4e34\u5e8a\u79d1\u7814\u8fdb\u884c\u6709\u673a\u878d\u5408\uff0c\u53c2\u4e0e\u653f\u4ea7\u5b66\u7814\u7528\u534f\u540c\u521b\u65b0\u4f53\u7cfb\uff0c\u4fc3\u8fdb\u533b\u836f\u7814\u53d1\u3002<\/p>\n

\u4ece\u533b\u751f\u7aef\uff0c\u5c3d\u7ba1\u77ed\u671f\u800c\u8a00\u57fa\u56e0\u68c0\u6d4b\u662f\u9526\u4e0a\u6dfb\u82b1\uff0c\u957f\u671f\u800c\u8a00\u662f\u53c2\u4e0e\u53d7\u8bca\u5bf9\u8c61\u5168\u751f\u547d\u5468\u671f\u5065\u5eb7\u7ba1\u7406\u7684\u5173\u952e\u5207\u5165\u70b9\uff0c\u4e0d\u4ec5\u6709\u5229\u4e8e\u4e2a\u4f53\u75c5\u7a0b\u7ba1\u7406\uff0c\u4e5f\u901a\u8fc7\u5927\u4eba\u7fa4\u7684\u57fa\u56e0\u4fe1\u606f\u79ef\u7d2f\uff0c\u4fc3\u8fdb\u4e34\u5e8a\u79d1\u7814\u6210\u679c\u4ea7\u51fa\u53ca\u8f6c\u5316\uff0c\u4e3a\u4eba\u6c11\u63d0\u4f9b\u7cfb\u7edf\u8fde\u7eed\u7684\u4e34\u5e8a\u53ca\u53ef\u62d3\u5c55\u7684\u5065\u5eb7\u670d\u52a1\u3002<\/p>\n

\u5bf9\u4e8e\u60a3\u8005\u800c\u8a00\uff0c\u5728\u77ed\u671f\u8981\u6c42\u7684\u4fbf\u5b9c\u3001\u9ad8\u6548\u533b\u7597\u670d\u52a1\u4e0e\u533b\u7597\u8d44\u6e90\u6709\u9650\u51b2\u7a81\u4e0b\u2014\u2014\u8fd9\u662f\u5168\u7403\u6027\u96be\u9898\u2014\u2014\u957f\u671f\u800c\u8a00\uff0c\u5c06\u4ece\u6210\u672c\u548c\u6548\u7387\u4e0a\u53d7\u76ca\u4e8e\u57fa\u56e0\u68c0\u6d4b\uff0c\u800c\u8fd9\u4e24\u70b9\u662f\u5c31\u533b\u83b7\u5f97\u611f\u7684\u6838\u5fc3\u8981\u7d20\u3002\u6210\u672c\u4e0a\uff0c\u5168\u57fa\u56e0\u7ec4\u6d4b\u5e8f\u6210\u672c\u5df2\u903c\u8fd1100\u7f8e\u5143\u2014\u2014\u5c3d\u7ba1\u8fd1\u4e24\u5e74\u201c\u8d85\u6469\u5c14\u5b9a\u5f8b\u201d\u964d\u5e45\u53d8\u7f13\u2014\u2014\u4f46\u968f\u7740\u4e0a\u6e38\u826f\u6027\u7ade\u4e89\u53ca\u66f4\u591a\u4ea7\u54c1\u4e0a\u5e02\u5c06\u5fc5\u7136\u8fdb\u4e00\u6b65\u964d\u4f4e\u5b9e\u8d28\u6210\u672c\uff1b\u800c\u53e6\u5916\u7684\u9690\u542b\u6210\u672c\u964d\u4f4e\u66f4\u503c\u5f97\u5173\u6ce8\uff0c\u5373\u901a\u8fc7\u4e2a\u4f53\u53ca\u5bb6\u5ead\u57fa\u56e0\u68c0\u6d4b\u4e0d\u4ec5\u5c06\u9884\u9632\u7aef\u53e3\u524d\u79fb\uff0c\u8fd8\u8d2f\u7a7f\u751f\u80b2\u3001\u51fa\u751f\u7f3a\u9677\u3001\u80bf\u7624\u53ca\u4f20\u611f\u67d3\u7b49\u7cfb\u5217\u7684\u751f\u547d\u5065\u5eb7\u4e3b\u9898\u7684\u5e72\u9884\u3002\u6548\u7387\u4e0a\uff0c\u5927\u6570\u636e\u7684\u89c4\u6a21\u6548\u5fc5\u5c06\u63d0\u5347\u4e34\u5e8a\u8bca\u7597\u6548\u7387\uff0c\u540c\u65f6\u76ee\u524d\u63a8\u52a8\u6709\u9700\u6c42\u7684\u60a3\u8005\u5408\u89c4\u53c2\u4e0e\u4e34\u5e8a\u8bd5\u9a8c\u52a0\u901f\u65b0\u836f\u7814\u53d1\u3002<\/p>\n

\u4ee5\u4e0a\u4e0d\u4ec5\u662f\u7406\u8bba\u5c42\u9762\u7684\u5e0c\u671b\uff0c\u7b14\u8005\u8ba4\u4e3a\u672a\u6765\u4e09\u5230\u4e94\u5e74\u4f1a\u7167\u8fdb\u73b0\u5b9e\uff0c\u5728\u76d1\u7ba1\u7a33\u5b9a\uff0c\u6280\u672f\u8fdb\u4e00\u6b65\u7814\u53d1\u6295\u5165\u60c5\u51b5\u7684\u57fa\u7840\u4e0a\u3002<\/p>\n

\u00a0\u4e09\u00a0\u00a0\u00a0\u00a0\u5065\u5eb7\u4e2d\u56fd\u7684\u4f7f\u547d\u4e0b\uff0c\u57fa\u56e0\u79d1\u6280\u7684\u672a\u6765\u4ef7\u503c\u53ca\u524d\u666f<\/div>\n

\u672a\u6765\uff0c\u57fa\u56e0\u79d1\u6280\u5728\u4e34\u5e8a\u7684\u5e94\u7528\u4ef7\u503c\u4ecd\u670980%\u4ee5\u4e0a\u7684\u53d1\u6398\u7a7a\u95f4\uff0c\u5728\u6b64\u57fa\u7840\u4e0a\uff0c\u5e02\u573a\u89c4\u6a21\u5c06\u4ece\u5343\u4ebf\u5143\u62d3\u5c55\u5230\u4e07\u4ebf\u5143\uff0c\u60e0\u53ca\u6c11\u751f\u5de5\u7a0b\u4ece\u5343\u4e07\u4eba\u6b21\u8986\u76d6\u5230\u4ebf\u4eba\u6b21\u3002<\/p>\n

\u8fd9\u91cc\uff0c\u4ece\u751f\u80b2\u652f\u6301\u53ca\u517b\u8001\u670d\u52a1\u6765\u4e3e\u4f8b\u8bf4\u660e\u3002<\/p>\n

\u6839\u636e\u56fd\u5bb6\u7edf\u8ba1\u5c40\u53d1\u5e03\u6570\u636e\u663e\u793a\uff0c2021\u5e74\u6211\u56fd\u5168\u5e74\u51fa\u751f\u4eba\u53e31062\u4e07\u4eba\uff0c\u4eba\u53e3\u51fa\u751f\u7387\u4e3a7.52\u2030\uff0c\u521b\u4e0b72\u5e74\u4ee5\u6765\u7684\u65b0\u4f4e\uff0c\u751f\u80b2\u6210\u672c\u662f\u5173\u952e\u56e0\u7d20\u4e4b\u4e00\u3002<\/p>\n

\u5728\u751f\u80b2\u7684\u533b\u7597\u6210\u672c\u65b9\u9762\uff0c\u57fa\u56e0\u68c0\u6d4b\u8fde\u540c\u53d1\u5c55\u4e2d\u7684\u57fa\u56e0\u6cbb\u7597\u6b63\u5728\u5e76\u8fdb\u4e00\u6b65\u964d\u4f4e\u5e76\u666e\u60e0\u6c11\u751f\uff0c\u5728\u300a2022\u57fa\u56e0\u884c\u4e1a\u84dd\u76ae\u4e66\u300b\u8c08\u5230\uff0c\u4ece\u68c0\u6d4b\u5510\u6c0f\u7efc\u5408\u5f81\u7b49\u7684\u65e0\u521b\u4ea7\u7ebf\u57fa\u56e0\u68c0\u6d4b\uff08NIPT\uff09\u5230\u68c0\u6d4b\u591a\u4e2a\u9057\u4f20\u6027\u75be\u75c5\u7684NIPT Plus\uff0c\u4ece\u4ea7\u524d\u5230\u5b55\u524d\u7684\u643a\u5e26\u8005\u7b5b\u67e5\uff08\u7279\u522b\u662f\u5730\u4e2d\u6d77\u8d2b\u8840\u7b49\u75be\u75c5\u9ad8\u53d1\u5730\u533a\uff09\uff0c\u4ece\u65b0\u751f\u513f\u7b5b\u67e5\u5230\u80da\u80ce\u690d\u5165\u524d\u7684\u57fa\u56e0\u68c0\u6d4b\uff0c\u5c06\u6709\u6548\u964d\u4f4e\u751f\u80b2\u6210\u672c\uff0c\u652f\u6301\u751f\u80b2\uff0c\u4ece\u6570\u636e\u548c\u4e34\u5e8a\u5c42\u9762\u8fdb\u884c\u5411\u5b55\u4ea7\u5987\u63d0\u4f9b\u751f\u80b2\u5168\u8fc7\u7a0b\u5065\u5eb7\u7ba1\u7406\u670d\u52a1\uff0c\u5e76\u6709\u6548\u964d\u4f4e\u51fa\u751f\u7f3a\u9677\u3002<\/p>\n

\u636e\u4eba\u6c11\u65e5\u62a5\u6d77\u5916\u7248\u62a5\u9053[8]\uff0c\u6e56\u5357\u5927\u5b66\u516c\u5171\u7ba1\u7406\u5b66\u9662\u7684\u7814\u7a76\u9879\u76ee\u53d1\u73b0\uff0c\u957f\u6c99\u5e02\u901a\u8fc7\u5bf9148538\u4f8b\u5b55\u5987\u5b9e\u65bd\u65e0\u521b\u4ea7\u524d\u57fa\u56e0\u7b5b\u67e5\uff0c\u6709\u6548\u907f\u514d\u4e86212\u4f8b\u5510\u6c0f\u513f\u7684\u51fa\u751f\uff0c\u9879\u76ee\u7684\u6210\u672c\u6548\u76ca\u6bd4\u8fbe1\uff1a8.75\u3002\u6cb3\u5317\u7701\uff0c\u56e0\u5df2\u5c06\u9879\u76ee\u8986\u76d6\u5168\u7701\u6240\u6709\u5b55\u5987\uff0c\u8fd9\u4e00\u9879\u76ee\u5355\u6b21\u7b5b\u67e5\u8d39\u7528\u7ecf\u653f\u5e9c\u8c08\u5224\u91c7\u8d2d\u964d\u81f3\u4e0d\u8db3400\u5143\u3002<\/p>\n

\u672a\u6765\uff0c\u4ece\u4e2a\u4f53\u5230\u5efa\u7acb\u5bb6\u5ead\u3001\u5bb6\u65cf\u3001\u793e\u533a\u53ca\u5927\u4eba\u7fa4\u751f\u80b2\u5065\u5eb7\u6570\u636e\uff0c\u5bf9\u4e8e\u5065\u5eb7\u751f\u80b2\u3001\u8f85\u52a9\u751f\u6b96\u3001\u51fa\u751f\u7f3a\u9677\u9632\u63a7\u3001\u65b0\u751f\u513f\u5065\u5eb7\u7b5b\u67e5\u7b49\u662f\u5fc5\u8981\u4e14\u81f3\u5173\u91cd\u8981\u7684\uff0c\u5176\u4e2d\u57fa\u56e0\u68c0\u6d4b\u662f\u8f83\u4e3a\u6210\u719f\u7684\u6280\u672f\u4e14\u5728\u4e0d\u65ad\u4f18\u5316\uff0c\u672a\u6765\u4e09\u5e74\u6709\u671b\u8fbe\u5230\u666e\u60e0\u7a0b\u5ea6\u3002<\/p>\n

\u517b\u8001\u670d\u52a1\u5c42\u9762\u3002\u6839\u636e\u516c\u5f00\u7edf\u8ba1\u6570\u636e\uff0c\u622a\u81f32021\u5e74\u5e95\uff0c\u6211\u56fd60\u5c81\u53ca\u4ee5\u4e0a\u8001\u5e74\u4eba\u8fbe\u52302.67\u4ebf\uff0c\u5360\u603b\u4eba\u53e3\u768418.9%\u3002\u6839\u636e2022\u5e749\u670820\u65e5\uff0c\u56fd\u5bb6\u536b\u751f\u5065\u5eb7\u59d4\u5458\u4f1a\u53ec\u5f00\u7684\u65b0\u95fb\u53d1\u5e03\u4f1a\uff0c2035\u5e74\u5de6\u53f3\uff0c\u6211\u56fd60\u5c81\u53ca\u4ee5\u4e0a\u8001\u5e74\u4eba\u53e3\u5c06\u7a81\u78344\u4ebf\uff0c\u5728\u603b\u4eba\u53e3\u4e2d\u7684\u5360\u6bd4\u5c06\u8d85\u8fc730%\uff0c\u8fdb\u5165\u91cd\u5ea6\u8001\u9f84\u5316\u9636\u6bb5\u3002<\/p>\n

\u5728\u517b\u8001\u7684\u533b\u7597\u6210\u672c\u65b9\u9762\uff0c\u57fa\u56e0\u68c0\u6d4b\u76ee\u524d\u6709\u6548\u9488\u5bf9ICU\u3001\u6025\u6551\u7b49\u5e94\u7528\u573a\u666f\u4e0b\u7684\u7cbe\u51c6\u76d1\u6d4b\u548c\u68c0\u6d4b\uff0c\u5e76\u9010\u6b65\u53d1\u5c55\u9488\u5bf9\u80bf\u7624\u7684\u9776\u5411\u57fa\u56e0\u6cbb\u7597\uff0c\u4ee5\u53ca\u9776\u5411\u836f\u7684\u7528\u836f\u6307\u5bfc\u53ca\u9884\u540e\u76d1\u6d4b\uff08\u4f34\u968f\u8bca\u65ad\uff09\uff0c\u672a\u6765\u5c06\u8fdb\u4e00\u6b65\u53d1\u5c55\u5e76\u5fc5\u7136\u8fbe\u6210\u9488\u5bf9\u6162\u6027\u75c5\u7684\u75c5\u7a0b\u5927\u6570\u636e\u7ba1\u7406\uff0c\u9488\u5bf9\u5065\u5eb7\u4eba\u7fa4\u7684\u65e9\u7b5b\u9884\u9632\u3002<\/p>\n

\u5c3d\u7ba1\u76ee\u524d\u7684\u6548\u679c\u53ca\u6210\u672c\u4ecd\u4e0d\u53ca\u671f\u671b\u503c\uff0c\u4f46\u968f\u7740\u5927\u6570\u636e\u7684\u89c4\u6a21\u6548\u5e94\uff0c\u6280\u672f\u53ca\u4ea7\u4e1a\u7684\u5468\u671f\u6027\u6f14\u5316\uff0c\u672a\u6765\u4e94\u5e74\u5728\u90e8\u5206\u573a\u666f\u4e0b\u6709\u671b\u63a5\u8fd1\u666e\u60e0\u7a0b\u5ea6\uff0c\u5e76\u534f\u540c\u533b\u7597\u670d\u52a1\u3001\u533b\u836f\u7814\u53d1\u7b49\u4f53\u7cfb\uff0c\u66f4\u597d\u3001\u66f4\u5feb\u3001\u66f4\u5168\u9762\u5730\u63d0\u5347\u8001\u5e74\u4eba\u7684\u5c31\u533b\u83b7\u5f97\u611f\u3002<\/p>\n

\u603b\u4e4b\uff0c\u6280\u672f\u548c\u4ea7\u4e1a\u7684\u53d1\u5c55\u662f\u5468\u671f\u6027\u7684\uff0c\u76ee\u524d\u57fa\u56e0\u68c0\u6d4b\u884c\u4e1a\u4ecd\u5728\u6210\u957f\u671f\uff0c\u9700\u8981\u6280\u672f\u8f6c\u5316\u53ca\u4ea7\u4e1a\u5b75\u5316\u652f\u6301\uff0c\u7279\u522b\u662f\u76d1\u7ba1\u7684\u7a33\u5b9a\u53ca\u5ba1\u8bc4\u4f18\u5316\uff0c\u8fd9\u70b9\u5bf9\u4e8e\u57fa\u56e0\u79d1\u6280\u8fd9\u4e00\u517c\u5907\u79d1\u6280\u653b\u5173\u53ca\u672a\u6765\u4ea7\u4e1a\u5c5e\u6027\u7684\u9886\u57df\u975e\u5e38\u91cd\u8981\u3002<\/p>\n

\u57282030\u5e74\u4e4b\u9645\uff0c\u56de\u9996\u7b5a\u8def\u84dd\u7f15\u7684\u7814\u53d1\u53ca\u4ea7\u4e1a\u5316\u4e4b\u8def\uff0c\u90a3\u662f\u901a\u5411\u4e3a\u5168\u4eba\u7fa4\u63d0\u4f9b\u516c\u5e73\u53ef\u53ca\u3001\u7cfb\u7edf\u8fde\u7eed\u7684\u5168\u751f\u547d\u5468\u671f\u5065\u5eb7\u670d\u52a1\uff0c\u4f5c\u4e3a\u672a\u6765\u4ea7\u4e1a\u52a9\u529b\u65b0\u7ecf\u6d4e\u5f15\u64ce\uff0c\u634d\u536b\u751f\u7269\u5b89\u5168\u53ca\u4fdd\u62a4\u751f\u7269\u591a\u6837\u6027\u7684\u5b9e\u5e72\u5174\u90a6\u4e4b\u8def\u3002<\/p>\n

\u3010\u5e7f\u544a\u65f6\u95f4\u3011<\/p>\n

\u300a2023\u57fa\u56e0\u884c\u4e1a\u84dd\u76ae\u4e66\u300b\u542f\u52a8\u5408\u4f5c\u00a0<\/p>\n

\u62db\u52df\u8054\u5408\u53d1\u5e03\u5408\u4f5c\u5355\u4f4d\uff0c\u6b22\u8fce\u5408\u4f5c<\/p>\n

\u8054\u7cfb\uff1ajiyinhui_1\uff08\u5546\u52a1\u5fae\u4fe1\uff09<\/div>\n
info@genonet.cn\uff0c400-088-0992<\/div>\n\n
\n
\"RmFicvQBAkgAKGB59GsiaDfyNqukVTU2mY7y45oPxvPL2Y4eib2wbbxdg8mwINAb3wJZANslBEh6ILw0giaicWmr1iag\"\/<\/figure><\/div>\n\n<\/p>\n

\n\n

\n
\"RmFicvQBAkgBvtcJiaibhe8pRKtPib9xfLZK1icKP37g1I0CiaFNdrMbD84tiaPeKuyEUiaBIibZQGW6nK8ndEJq7PTXibYg\"\/<\/figure><\/div>\n\n

\uff08\u6ce8\uff1a\u5c01\u9762\u53ca\u76ee\u5f55\u4ee5\u5b9e\u9645\u53d1\u5e03\u4e3a\u51c6\uff0c\u77e5\u8bc6\u4ea7\u6743\u5c5e\u4e8e\u57fa\u56e0\u6167\uff09<\/p>\n

\uff08\u611f\u8c22\u9f50\u78b3\u79d1\u6280\u3001\u57fa\u77f3\u751f\u547d\u3001\u6e90\u53e4\u7eaa\u3001\u534e\u4e3a\u4e91\u3001\u534e\u5927\u667a\u9020\u3001\u8d1d\u5eb7\u533b\u7597\u3001IDT\u57c3\u5fb7\u7279\u3001\u81fb\u548c\u79d1\u6280\u3001\u9752\u5c9b\u81ea\u8d38\u7247\u533a\u00b7\u4e2d\u5fb7\u751f\u6001\u56ed\u5bf9\u300a2022\u57fa\u56e0\u884c\u4e1a\u84dd\u76ae\u4e66\u300b\u7684\u652f\u6301\uff0c\u4f7f\u5f97\u84dd\u76ae\u4e66\u514d\u8d39\u53d1\u5e03\uff0c\u63a8\u5e7f\u57fa\u56e0\u79d1\u6280\uff0c\u4fc3\u8fdb\u4ea7\u5b66\u7814\u7528\u878d\u5408\u53d1\u5c55\u3002\u300a2023\u57fa\u56e0\u884c\u4e1a\u84dd\u76ae\u4e66\u300b\u6b63\u5f0f\u542f\u52a8\uff0c\u6b22\u8fce\u5b66\u4f1a\u3001\u534f\u4f1a\u3001\u4f01\u4e1a\u7b49\u53c2\u4e0e\u8054\u5408\u53d1\u5e03\u3002\uff09<\/div>\n
\u53c2\u8003\u8d44\u6599\uff1a<\/div>\n
1\uff09https:\/\/www.fda.gov\/medical-devices\/in-vitro-diagnostics\/laboratory-developed-tests<\/div>\n
2\uff09https:\/\/www.antpedia.com\/news\/38\/n-1248438.html<\/div>\n
3\uff09https:\/\/crsreports.congress.gov\/product\/pdf\/IF\/IF11389<\/div>\n
4\uff09https:\/\/www.legislation.gov.uk\/eudr\/1998\/79<\/div>\n
5\uff09https:\/\/www.cn-healthcare.com\/article\/20150612\/content-475050.html?from=mail<\/div>\n
6\uff09Freedman AN et. al., Use of Next-Generation Sequencing Tests to Guide Cancer Treatment: Results From a Nationally Representative Survey of Oncologists in the United,\u00a0 States. JCO Precis Oncol. 2018<\/div>\n
7\uff09Schon KR, et.al.,\u00a0Use of whole genome sequencing to determine genetic basis of suspected mitochondrial disorders: cohort study. BMJ. 2021<\/div>\n
8\uff09\u4eba\u6c11\u65e5\u62a5\u6d77\u5916\u7248\uff1a\u65e2\u8981\u201c\u613f\u610f\u751f\u201d\u8fd8\u8981\u201c\u751f\u5f97\u597d\u201d\uff0c2022\u5e7410\u670825\u65e5\u00a0 \u7b2c 09 \u7248\uff0chttp:\/\/paper.people.com.cn\/rmrbhwb\/html\/2022-10\/25\/content_25945562.htm<\/div>\n
\u00a0<\/div>\n
\u6269\u5c55\u9605\u8bfb<\/div>\n
\u7a7f\u8d8a\u5468\u671f\uff0c\u57fa\u56e0\u884c\u4e1a\u9ad8\u8d28\u91cf\u53d1\u5c55\u7684\u601d\u8003\uff08\u4e8c\uff09<\/a><\/div>\n
\u300a2022\u57fa\u56e0\u884c\u4e1a\u84dd\u76ae\u4e66\u300b\u9996\u53d1\uff08\u514d\u8d39\u4e0b\u8f7d\uff09<\/a><\/div>\n
\u3010\u58f0\u660e\u3011\u4e3a\u4e86\u63a8\u52a8\u57fa\u56e0\u53ca\u6570\u5b57\u751f\u547d\u5065\u5eb7\u79d1\u6280\u63a8\u5e7f\u3001\u4ea7\u4e1a\u53d1\u5c55\u53ca\u653f\u4ea7\u5b66\u7814\u7528\u8fde\u63a5\uff0c\u57fa\u56e0\u6167\u79c9\u6301\u4e13\u4e1a\u3001\u8d4b\u80fd\u3001\u4e2d\u7acb\u7684\u7acb\u573a\u6536\u96c6\u3001\u5206\u6790\u53ca\u53d1\u5e03\u76f8\u5173\u4fe1\u606f\u3002\u4f46\u7531\u4e8e\u65f6\u6548\u6027\u53ca\u884c\u4e1a\u7279\u6b8a\u6027\uff0c\u6240\u520a\u767b\u5185\u5bb9\u4ec5\u4f9b\u7814\u7a76\u53c2\u8003\uff0c\u672a\u7ecf\u8bf4\u660e\u4e0d\u4f5c\u4e3a\u51b3\u7b56\u4f9d\u636e\uff1b\u672c\u6587\u76f8\u5173\u4fe1\u606f\u4e0d\u4ee3\u8868\u57fa\u56e0\u6167\u7684\u89c2\u70b9\uff1b\u57fa\u56e0\u6167\u5e73\u53f0\u520a\u767b\u7684\u539f\u521b\u5185\u5bb9\u7684\u77e5\u8bc6\u4ea7\u6743\u4e3a\u201c\u57fa\u56e0\u6167\u201d\u5546\u6807\u62e5\u6709\u8005\u53ca\u76f8\u5173\u6743\u5229\u4eba\u6240\u6709\uff1b\u6b22\u8fce\u8f6c\u8f7d\uff0c\u8f6c\u8f7d\u8bf7\u7533\u8bf7\u5e76\u6ce8\u660e\u6765\u6e90\u3002\u6b22\u8fce\u4e2a\u4eba\u53ca\u673a\u6784\u6295\u7a3f\u53ca\u5408\u4f5c\u3002<\/div>\n

\u00a0\u5173\u4e8e\u57fa\u56e0\u6167\u00a0<\/p>\n

\u6df1\u5733\u57fa\u56e0\u754c\u79d1\u6280\u54a8\u8be2\u6709\u9650\u516c\u53f8\uff08\u57fa\u56e0\u6167\uff09\u4e13\u6ce8\u6570\u5b57\u751f\u547d\u5065\u5eb7\u4ea7\u4e1a\u521b\u65b0\u670d\u52a1\u3002\u521b\u59cb\u56e2\u961f\u6df1\u8015\u884c\u4e1a\u4e00\u7ebf\u5341\u4f59\u5e74\uff0c\u79c9\u6301\u201c\u4f7f\u8fde\u63a5\u4ea7\u751f\u4ef7\u503c\uff0c\u7528\u6570\u636e\u770b\u89c1\u672a\u6765\u201d\u7684\u7406\u5ff5\uff0c\u57fa\u4e8e\u4ea7\u4e1a\u667a\u5e93\u548c\u4e13\u4e1a\u5185\u5bb9\uff0c\u63d0\u4f9b\u4ea7\u4e1a\u89c4\u5212\u3001\u884c\u7814\u54a8\u8be2\u3001\u79d1\u6280\u63a8\u5e7f\u7b49\u670d\u52a1\u3002\u8fde\u7eed\u4e94\u5e74\u53d1\u5e03\u884c\u4e1a\u84dd\u76ae\u4e66\uff0c\u88ab\u56fd\u5bb6\u53ca\u7701\u5e02\u7ea7\u4ea7\u4e1a\u62a5\u544a\u6536\u5f55\uff0c\u534f\u52a9\u5b66\u4f1a\u4e13\u5bb6\u7b49\u7ec4\u7ec7\u53d1\u5e03\u591a\u9879\u884c\u4e1a\u5171\u8bc6\u548c\u56e2\u6807\uff0c\u63a8\u52a8\u751f\u547d\u79d1\u6280\u666e\u60e0\u548c\u4ea7\u4e1a\u521b\u65b0\u53d1\u5c55\u3002<\/div>\n
\u2606\u00a0\u56fd\u53d1\u6539\u300a\u6218\u7565\u6027\u65b0\u5174\u4ea7\u4e1a\u53d1\u5c55\u5c55\u671b\u300b\u767d\u76ae\u4e66\u6267\u7b14<\/div>\n
\u2606\u00a0\u8fde\u7eed\u4e94\u5e74\u53d1\u5e03\u57fa\u56e0\u884c\u4e1a\u84dd\u76ae\u4e66<\/div>\n
\u2606\u00a0\u4e2d\u56fd\u6297\u764c\u534f\u4f1a\u80bf\u7624\u6807\u5fd7\u4e13\u4e1a\u59d4\u5458\u4f1a\u6218\u7565\u5408\u4f5c\u5355\u4f4d<\/div>\n
\u2606\u00a0\u4e2d\u56fd\u9057\u4f20\u5b66\u4f1a\u751f\u7269\u4ea7\u4e1a\u4fc3\u8fdb\u59d4\u5458\u4f1a\u59d4\u5458<\/div>\n
\u2606\u00a0\u5e7f\u4e1c\u7701\u7cbe\u51c6\u533b\u5b66\u5e94\u7528\u5b66\u4f1a\u653f\u7b56\u7814\u7a76\u5e94\u7528\u5206\u4f1a\u5e38\u59d4<\/div>\n
\u2606\u00a0\u6df1\u5733\u5e02\u5065\u5eb7\u4ea7\u4e1a\u53d1\u5c55\u4fc3\u8fdb\u4f1a\u526f\u4f1a\u957f\u5355\u4f4d<\/div>\n
\u2606\u00a0\u53c2\u4e0e\u7ec4\u7ec7\u673a\u6784\u53d1\u5e03\u591a\u9879\u884c\u4e1a\u5171\u8bc6\u548c\u56e2\u4f53\u6807\u51c6<\/div>\n
\u2606\u00a0\u7ec4\u7ec7\u57fa\u56e0\u68c0\u6d4b\u8054\u76df\uff08\u7b79\uff09\u9996\u5c4a\u3001\u7b2c\u4e8c\u5c4a\u4f1a\u8bae<\/div>\n
\u2606\u00a0\u4e3b\u529e\u6570\u5b57\u5065\u5eb7\u79c1\u8463\u4f1a\u3001\u5927\u6e7e\u533a\u751f\u547d\u5065\u5eb7\u521b\u65b0\u8bba\u575b<\/div>\n
\u2606\u00a0\u53d7\u9080\u4e3a\u534e\u897f\u3001\u56e0\u7f8e\u7eb3\u3001\u534e\u5927\u3001\u4e0a\u6d77\u4ea4\u5927\u7b49\u4f5c\u62a5\u544a<\/div>\n<\/p>","protected":false},"excerpt":{"rendered":"

\u8fd1\u671f\u968f\u7740\u5e7f\u5dde\u3001\u4e0a\u6d77\u3001\u676d\u5dde\u7b49\u5730\u8bd5\u70b9\u63a8\u5e7f\u4e34\u5e8aLDT\uff0c\u4e34 …<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"close","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9],"tags":[1549,1527],"class_list":["post-8015","post","type-post","status-publish","format-standard","hentry","category-industryresearch","tag-1549","tag-1527"],"_links":{"self":[{"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/posts\/8015","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/comments?post=8015"}],"version-history":[{"count":4,"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/posts\/8015\/revisions"}],"predecessor-version":[{"id":13348,"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/posts\/8015\/revisions\/13348"}],"wp:attachment":[{"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/media?parent=8015"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/categories?post=8015"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/tags?post=8015"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}