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\u57fa\u56e0\u7684\u70b9\u7a81\u53d8+\u5927\u4fbf\u9690\u8840\u4e2d\u7684\u8840\u7ea2\u86cb\u767d\u68c0\u6d4b\u201d\uff0c\u5b9e\u73b0\u7ed3\u76f4\u80a0\u764c\u7b5b\u67e592.3%\u7684\u7075\u654f\u5ea6\uff1b2020\u5e74\u6211\u56fd\u9996\u4e2a\u83b7\u6279\u7684\u80bf\u7624\u65e9\u7b5b\u4ea7\u54c1\u201c\u5e38\u536b\u6e05\u201d\u91c7\u7528\u7c7b\u4f3c\u7684\u6280\u672f\u8def\u5f84\uff0c\u5373\u57fa\u4e8e\u201c\u4f53\u5916\u7caa\u4fbf\u6837\u672c\u4e2d\u7684KRAS 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src=\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgCgakjS1chh6nMiaw3yR5PABBqj8r9Ttlf8IPtRWPUNUusoDhRphxmcibHyKe1AuaNdrcK0BZAmUhQA.png\" 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Cologuard\u548c\u5e7f\u9614\u7684\u53d7\u4f17\u5e02\u573a\u903b\u8f91\u5e26\u6765\u8f83\u9ad8\u4f30\u503c\uff0c2022\u5e74\u56e0\u4e3a\u5e02\u573a\u4e0d\u53ca\u9884\u671f\u5e26\u6765\u8d44\u672c\u7684\u7406\u6027\u56de\u5f52\uff0c2023\u5e74\u7ee7\u800c\u7531\u4e8e\u9ad8\u989d\u7684\u9500\u552e\u8d39\u7528\u3001\u5927\u89c4\u6a21\u961f\u5217\u9879\u76ee\u6210\u672c\u538b\u529b\u5e26\u6765\u53c8\u4e00\u8f6e\u4ea7\u4e1a\u4f18\u5316\u5468\u671f\u3002<\/p>\n<\/p>\n<p>Exact Science\u76842022\u5e74\u9500\u552e\u8d39\u7528\u9ad8\u8fbe8.46\u4ebf\u7f8e\u5143\uff0c\u4f46\u6536\u5165\/\u9500\u552e\u8d39\u7528\u6bd42.46\uff0c\u8fd9\u4e2a\u6570\u5b57\u5bf9\u4e8e\u56fd\u5185\u4e0a\u5e02\u4f01\u4e1a\u662f\u975e\u5e38\u5927\u7684\u6311\u6218\u3002\u77ed\u671f\u63a7\u5236\u9500\u552e\u8d39\u7528\u7684\u6548\u679c\uff0c\u8fdc\u4e0d\u53ca\u63d0\u9ad8\u6536\u5165\/\u9500\u552e\u8d39\u7528\u5360\u6bd4\uff0c\u5373\u7a81\u7834\u6536\u5165\u589e\u957f\u74f6\u9888\u3002\u9488\u5bf9\u8fd9\u70b9\uff0c\u4ee5\u8bfa\u8f89\u5065\u5eb7\u4e3a\u4f8b\uff0c\u636e\u516c\u5f00\u8d44\u6599\uff0c\u4e00\u65b9\u9762\u9009\u62e9\u4e0e\u963f\u65af\u5229\u5eb7\u5408\u4f5c\uff0c\u5171\u540c\u5728\u4e2d\u56fd\u5927\u9646\u5730\u533a\u516c\u7acb\u533b\u9662\u3001\u836f\u5e97\u548c\u4e92\u8054\u7f51\u533b\u9662\u63a8\u5e7f\u5e38\u536b\u6e05\uff0c\u901a\u8fc7\u4e0e\u4eac\u4e1c\u5065\u5eb7\u3001\u5e73\u5b89\u5065\u5eb7\u533b\u7597\u3001\u4e91\u9e4a\u533b\u53ca\u4e2d\u56fd\u90ae\u653f\u7b49\u5408\u4f5c\uff0c\u63d0\u5347\u65e9\u7b5b\u4ea7\u54c1\u5728\u4e34\u5e8a\u3001\u6d88\u8d39\u8005\u53ca\u4fdd\u9669\u5e02\u573a\u7684\u6e17\u900f\u7387\uff1b\u53e6\u4e00\u65b9\u9762\u4e0ePrenetics\u5408\u4f5c\u5c06\u5e38\u536b\u6e05\u9500\u5f80\u6e2f\u6fb3\u53f0\u4ee5\u53ca\u201c\u51fa\u6d77\u201d\u4e1c\u5357\u4e9a\u56fd\u5bb6\u6216\u5730\u533a\uff0c\u5728\u4e2d\u56fd\u5408\u4f5c\u6e20\u9053\u5305\u62ec\u5feb\u9a8c\u4fdd\u3001\u6e2f\u6021\u533b\u9662\u3001\u9999\u6e2f\u4f53\u68c0\u53ca\u5c1a\u81f3\u533b\u7597\u7b49\u8d85\u8fc750\u5bb6\u673a\u6784\uff1b2023\u5e74\uff0c\u9e4d\u8fdc\u751f\u7269\u4e0e\u9a6c\u6765\u897f\u4e9a\u533b\u7597\u5668\u68b0\u516c\u53f8Vanguard MedTech\u8fbe\u6210\u6218\u7565\u5408\u4f5c\uff0c\u4ece\u7ed3\u76f4\u80a0\u764c\u51fa\u53d1\u5171\u540c\u62d3\u5c55\u9a6c\u6765\u897f\u4e9a\u7684\u80bf\u7624\u65e9\u68c0\u5e02\u573a\uff0c\u63a8\u52a8\u9e4d\u8fdc\u751f\u7269\u7684\u80a0\u764c\u591a\u57fa\u56e0\u7532\u57fa\u5316\u68c0\u6d4b\u6280\u672fColonAiQ\u00ae\u843d\u5730\u9a6c\u6765\u897f\u4e9a\uff1b\u540c\u5e74\uff0c\u9e4d\u8fdc\u751f\u7269\u8054\u5408\u7f8e\u56fd\u7a81\u7834\u57fa\u56e0\u7ec4\u5b66\uff08Breakthrough Genomics\uff09\u516c\u53f8\u5728\u52a0\u5229\u798f\u5c3c\u4e9a\u5dde\u542f\u52a8\u764c\u75c7\u65e9\u671f\u7b5b\u67e5\u548c\u68c0\u6d4b\u670d\u52a1\uff0c\u8fd0\u7528\u9e4d\u8fdc\u751f\u7269\u81ea\u4e3b\u7814\u53d1\u7684\u80f0\u817a\u764c\u6db2\u4f53\u6d3b\u68c0\u6280\u672f PDACatchTM\u670d\u52a1\u5e7f\u5927\u60a3\u8005\u3002<\/p>\n<\/p>\n<p>\u5728\u5927\u89c4\u6a21\u524d\u77bb\u6027\u961f\u5217\u7684\u7814\u7a76\u5145\u5206\u6027\u548c\u8d44\u91d1\u5fc5\u8981\u6027\u7684\u96be\u70b9\u4e0a\uff0c\u4e00\u65b9\u9762\u53ef\u4ee5\u53c2\u8003\u9e4d\u8fdc\u751f\u7269\u4e0e\u626c\u5dde\u5e02\u9097\u6c5f\u533a\uff0c\u4e16\u548c\u57fa\u56e0\u4e0e\u5357\u4eac\u6c5f\u5317\u65b0\u533a\u5408\u4f5c\u7684\u6848\u4f8b\uff0c\u653f\u4f01\u5408\u529b\u805a\u96c6\u9ad8\u7aef\u6280\u672f\u3001\u9ad8\u7aef\u4eba\u624d\u548c\u751f\u4ea7\u5236\u9020\u57fa\u5730\uff0c\u6210\u4e3a\u751f\u7269\u5065\u5eb7\u4ea7\u4e1a\u805a\u96c6\u5730\u7684\u540c\u65f6\u9020\u5c31\u5f53\u5730\u6c11\u751f\u5de5\u7a0b\uff1b\u53e6\u4e00\u65b9\u9762\uff0c\u901a\u8fc7\u5f15\u8fdb\u56fd\u6709\u8d44\u672c\u3001\u8de8\u754c\u5934\u90e8\u673a\u6784\u6218\u7565\u8d44\u672c\u662f\u89e3\u51b3\u5404\u5927\u4f01\u4e1a\u5f53\u4e0b\u201c\u8f93\u8840\u201d\u5927\u5173\u7684\u91cd\u70b9\u3002\u9664\u6b64\u4e4b\u5916\uff0c\u6280\u672f\u4e0a\u7684\u4e0d\u8db3\uff0c\u968f\u7740\u68c0\u6d4b\u6280\u672f\u3001\u7b97\u6cd5\u548c\u5927\u89c4\u6a21\u4eba\u7fa4\u961f\u5217\u7684\u6210\u679c\u8f6c\u5316\uff0c\u957f\u671f\u4e0a\u4e0d\u6784\u6210\u963b\u529b\uff1b\u6280\u672f\u8fed\u4ee3\u5e26\u6765\u4e34\u5e8a\u5e94\u7528\u573a\u666f\u7684\u53ef\u53ca\u6027\u4ee5\u53ca\u8fdb\u800c\u5e02\u573a\u51c6\u5165\u7684\u52a0\u901f\uff0c\u5176\u4e2d\u7684\u5173\u952e\u662f\u5ef6\u957f\u751f\u5b58\u65f6\u95f4\uff0c\u5f00\u62d3\u5e02\u573a\u540c\u65f6\u7b49\u5f85\u5e02\u573a\u9010\u6b65\u6210\u719f\u3002<\/p>\n<\/p>\n<p>\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter\"><img decoding=\"async\" src=\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgCgakjS1chh6nMiaw3yR5PABs8DqyNnslA21uUbLp4gQFod7PCjtCAnprtTYuL6icaFeSf48aTDmfYw.png\" alt=\"RmFicvQBAkgCgakjS1chh6nMiaw3yR5PABs8DqyNnslA21uUbLp4gQFod7PCjtCAnprtTYuL6icaFeSf48aTDmfYw\"\/><\/figure><\/div>\n\n<\/p>\n<p>\u622a\u6b62\u6210\u7a3f\u65e5\uff0c\u9e4d\u8fdc\u751f\u7269\u81ea\u4e3b\u7814\u53d1\u7684 PDACatchTM\u68c0\u6d4b\u83b7\u5f97FDA\u7684\u7a81\u7834\u6027\u533b\u7597\u5668\u68b0\u8ba4\u5b9a\u3002PDACatchTM\u662f\u4e00\u79cd\u65b0\u578b\u7684\u57fa\u4e8eDNA\u7532\u57fa\u5316\u3001\u7528\u4e8e\u68c0\u6d4b\u9ad8\u98ce\u9669\u4eba\u7fa4\u4e2d\u80f0\u817a\u764c\u548c\u764c\u524d\u75c5\u53d8\u7684\u6db2\u4f53\u6d3b\u68c0\u68c0\u6d4b\u6280\u672f\u3002\u8fd9\u4f53\u73b0\u51fa\u6211\u56fd\u5728\u764c\u75c7\u65e9\u7b5b\u9886\u57df\u7684\u6280\u672f\u5148\u8fdb\u6027\u4ee5\u53ca\u5728\u80f0\u817a\u764c\u7b49\u672a\u6765\u66f4\u591a\u764c\u79cd\u751a\u81f3\u6cdb\u764c\u79cd\u65e9\u7b5b\u5e02\u573a\u7684\u5e7f\u9614\u524d\u666f\u3002<\/p>\n<\/p>\n<p>\u4e09\u3001\u80bf\u7624\u4f34\u968f\u8bca\u65ad<\/p>\n<p>\u4f34\u968f\u8bca\u65ad\uff08Companion Diagnostics, CDx\uff09\u4ece\u82f1\u6587\u76f4\u8bd1\u800c\u6765\uff0c\u5373\u4f34\u968f\u7740\u6cbb\u7597\u800c\u8fdb\u884c\u7684\u8bca\u65ad\uff1b\u4ece\u4f5c\u7528\u4e0a\u53ef\u8fd1\u4f3c\u7406\u89e3\u4e3a\u7528\u836f\u6307\u5bfc\uff0c\u5728\u57fa\u56e0\u5c42\u9762\uff08\u4f34\u968f\u8bca\u65ad\u4e0d\u9650\u4e8e\u57fa\u56e0\uff09\u96b6\u5c5e\u4e8e\u836f\u7269\u57fa\u56e0\u7ec4\u3002<\/p>\n<\/p>\n<p>\u6839\u636e FDA 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alt=\"RmFicvQBAkgCgakjS1chh6nMiaw3yR5PABOm5via0Jh9eWRvY15YxQibQTqamrKVUiaRACY7wfic0viavRfRyErUoBz8A\"\/><\/figure><\/div>\n\n<\/p>\n<p>\u4f34\u968f\u8bca\u65ad\u7684\u6280\u672f\u57fa\u7840\u662f\u5206\u5b50\u5206\u578b\u3002\u7ec4\u7ec7\u5206\u578b\u548c\u5206\u5b50\u5206\u578b\u662f\u80bf\u7624\u4f34\u968f\u8bca\u65ad\u671f\u95f4\u8fdb\u884c\u5206\u578b\u7684\u4e3b\u8981\u65b9\u6cd5\uff0c\u7ec4\u7ec7\u5206\u578b\u4e3b\u8981\u4f9d\u636e\u75c5\u7406\u5207\u7247\u624b\u6bb5\uff0c\u800c\u5206\u5b50\u5206\u578b\u4e3b\u8981\u4f9d\u636e NGS 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Approved\uff09\u9488\u5bf961\u79cd\u836f\u7269\uff08\u548c\u836f\u7269\u7ec4\u5408\uff09\u768453\u79cd\u4f34\u968f\u8bca\u65ad\u8bd5\u5242\u4e0a\u5e02\uff0c\u4e3b\u8981\u96c6\u4e2d\u5728\u6297\u80bf\u7624\u9886\u57df\uff0c\u7279\u522b\u662f\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u3001\u4e73\u817a\u764c\u3001\u7ed3\u76f4\u80a0\u764c\u7b49\u3002\u5728\u6280\u672f\u5e73\u53f0\u65b9\u9762\uff0c2011\u5e74\u4ee5\u524d\u4ee5\u514d\u75ab\u7ec4\u5316\uff08IHC\uff09\u548c\u539f\u4f4d\u6742\u4ea4\uff08ISH\uff09\u4e3a\u4e3b\uff1b2011\u5e74\u81f3\u4eca\uff0cPCR\u6210\u4e3aFDA\u6279\u51c6\u7684CDx \u4e2d\u5360\u6bd4\u6700\u5927\u7684\u6280\u672f\uff08\u8fd140%\uff09\uff1b2016 \u5e74\u4ee5\u540e\uff0cNGS \u6280\u672f\u7684\u6570\u91cf\u548c\u6bd4\u4f8b\u9010\u6b65\u589e\u52a0\u3002<\/p>\n<\/p>\n<p>\u4ea7\u4e1a\u673a\u6784\u65b9\u9762\uff0c\u7f57\u6c0f\u8bca\u65ad\u901a\u8fc7\u6536\u8d2d Ventana \u548c Foundation Medicine \u6210\u4e3aCDx\u5e03\u5c40\u6700\u5e7f\u7684\u5934\u90e8\u673a\u6784\uff0c\u5176\u6b21\u662f\u5b89\u6377\u4f26\uff08\u65d7\u4e0bDako\uff09\u548c\u51ef\u6770\u3002\u57fa\u4e8eNGS\u6280\u672f\u7684CDx \u5c06\u662f\u672a\u6765\u7ade\u4e89\u6700\u6fc0\u70c8\u7684\u9886\u57df\uff0c\u76ee\u524d\u4e3b\u8981\u5382\u5546\u5305\u62ec\u7f57\u6c0f\u8bca\u65ad\u3001\u8d5b\u9ed8\u98de\u548c\u56e0\u7f8e\u7eb3\u3002\u6839\u636e2022\u5e74\u516c\u5f00\u8d22\u62a5\uff0c\u7f57\u6c0f\u8bca\u65ad\u7684\u8425\u6536\u7ea6\u4e3a200\u4ebf\u7f8e\u5143\uff08177 \u4ebf\u745e\u58eb\u6cd5\u90ce\uff09\uff0c\u540c\u6bd4\u589e\u957f3%\uff1b\u4f34\u968f\u8bca\u65ad\u548c\u9ad8\u7aef\u67d3\u8272\u5e26\u6765\u75c5\u7406\u8bca\u65ad\u4e1a\u52a111%\u7684\u589e\u957f\u7387\u3002\u4e0e\u6b64\u540c\u65f6\uff0c2022\u5e74\u7f57\u6c0f\u8bca\u65ad\u4f18\u5316\u4e86FMI \u4e2d\u56fd\u56e2\u961f\u3002\u6211\u56fdNMPA\u6279\u51c6\u7684\u6d77\u5916\u4f01\u4e1a\u4f34\u968f\u8bca\u65ad\u8bd5\u5242\u4e3a\u4e2a\u4f4d\u6570\uff0cNGS\u4f34\u968f\u8bca\u65ad\u8bd5\u5242\u5747\u6765\u81ea\u56fd\u4ea7\u5382\u5546\uff0c\u56e0\u6b64 CDx \u5728\u6211\u56fd\u7684\u53d1\u5c55\u5355\u72ec\u9610\u8ff0\u3002<\/p>\n<\/p>\n<p>\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter\"><img decoding=\"async\" src=\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgCgakjS1chh6nMiaw3yR5PABYZiaY24LSuRBlB6It00ibqWjWFp9e96aL3vo9icKWxFMwYuZcYmVQvuzg.png\" alt=\"RmFicvQBAkgCgakjS1chh6nMiaw3yR5PABYZiaY24LSuRBlB6It00ibqWjWFp9e96aL3vo9icKWxFMwYuZcYmVQvuzg\"\/><\/figure><\/div>\n\n<\/p>\n<p>\u6211\u56fd\u4f34\u968f\u8bca\u65ad\u8d77\u6b65\u4e8e2018\u5e74\uff0c\u8fd1\u51e0\u5e74\u53d1\u5c55\u8fc5\u901f\uff0c\u4e3b\u8981\u662f\u5728 NGS \u6280\u672f\u5e73\u53f0\u65b9\u9762\u3002\u6839\u636e\u300a\u65b0\u578b\u6297\u80bf\u7624\u836f\u7269\u4e34\u5e8a\u5e94\u7528\u6307\u5bfc\u539f\u5219\uff082022 \u5e74\u7248\uff09\u300b\uff0c57 \u79cd\u9776\u5411\u836f\u9700\u8981\u4f34\u968f\u8bca\u65ad\uff0c\u5360\u636e\u8fd150%\u3002<\/p>\n<\/p>\n<div>2018\u5e741\u6708\uff0c\u6211\u56fd\u9996\u4e2a\u4f34\u968f\u8bca\u65ad\u4ea7\u54c1\u83b7\u6279\uff1a\u827e\u5fb7\u751f\u7269 Super-ARMS\u00ae\u00a0EGFR\uff08\u57fa\u4e8ePCR\uff09\uff1b<\/div>\n<div>2018\u5e747\u6708\uff0c\u6211\u56fd\u9996\u4e2aNGS\u80bf\u7624\u4f34\u968f\u8bca\u65ad\u4ea7\u54c1\u83b7\u6279\uff1a\u71c3\u77f3\u533b\u5b66\u7684\u4ebaEGFR\/ALK\/ BRAF\/KRAS \u57fa\u56e0\u7a81\u53d8\u8054\u5408\u68c0\u6d4b\u8bd5\u5242\u76d2\uff08\u53ef\u9006\u672b\u7aef\u7ec8\u6b62\u6d4b\u5e8f\u6cd5\uff09\uff1b<\/div>\n<div>2018 \u5e74 11 \u6708\uff0c\u6211\u56fd\u9996\u4e2a NGS \u6cdb\u80bf\u7624\u4f34\u968f\u8bca\u65ad\u83b7\u6279\uff1a\u827e\u5fb7\u751f\u7269\u7684\u4eba\u7c7b 10 \u57fa\u56e0\u7a81\u53d8\u8054\u5408\u68c0\u6d4b\u8bd5\u5242\u76d2\uff1b<\/div>\n<div>2019\u5e74 6 \u6708\uff0c\u5317\u4eac\u5e02\u5c06\u4f34\u968f\u8bca\u65ad\u9879\u76ee\u7eb3\u5165\u5176\u4e59\u7c7b\u533b\u4fdd\uff1b<\/div>\n<div>2019\u5e74 8 \u6708\uff0c\u6211\u56fd\u9996\u4e2aPD-1\u5355\u6297\u4f34\u968f\u8bca\u65ad\u83b7\u6279\uff1a\u7f57\u6c0f\u8bca\u65ad\u7684PD-L1 IHC 22C3 pharmDx\uff1b<\/div>\n<div>2020\u5e74 8\u6708\uff0c\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u533b\u7597\u5668\u68b0\u6280\u672f\u5ba1\u8bc4\u4e2d\u5fc3\uff08CMDE\uff09\u53d1\u5e03\u9996\u4e2a\u4f34\u968f\u8bca\u65ad\u7684\u6307\u5bfc\u539f\u5219\u300a\u5df2\u4e0a\u5e02\u6297\u80bf\u7624\u836f\u7269\u7684\u4f34\u968f\u8bca\u65ad\u8bd5\u5242\u4e34\u5e8a\u8bd5\u9a8c\u6307\u5bfc\u539f\u5219\uff08\u5f81\u6c42\u610f\u89c1\u7a3f\uff09\u300b\uff1b<\/div>\n<div>2021 \u5e74 11 \u6708\uff0c\u56fd\u5bb6\u836f\u76d1\u5c40\u53d1\u5e03\u300a\u6297\u80bf\u7624\u836f\u7269\u7684\u975e\u539f\u7814\u4f34\u968f\u8bca\u65ad\u8bd5\u5242\u4e34\u5e8a\u8bd5\u9a8c\u6ce8\u518c\u5ba1\u67e5\u6307\u5bfc\u539f\u5219\u300b\u3001\u300a\u4f7f\u7528\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u5883\u5916\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u7684\u6ce8\u518c\u5ba1\u67e5\u6307\u5bfc\u539f\u5219\u300b\uff1b<\/div>\n<div>2022 \u5e74 3 \u6708\uff0c\u9996\u4e2a\u56fd\u4ea7 PD-L1 \u68c0\u6d4b\u8bd5\u5242\u76d2\uff08\u514d\u75ab\u6cbb\u7597\u836f\u7269\u4f34\u968f\u8bca\u65ad\uff09\u83b7\u6279\uff1b<\/div>\n<div>2022 \u5e74 6 \u6708\uff0cCMDE \u53d1\u5e03\u300a\u4e0e\u6297\u80bf\u7624\u836f\u7269\u540c\u6b65\u7814\u53d1\u7684\u539f\u7814\u4f34\u968f\u8bca\u65ad\u8bd5\u5242\u4e34\u5e8a\u8bd5\u9a8c\u6ce8\u518c\u5ba1\u67e5\u6307\u5bfc\u539f\u5219\u300b\u3002<\/div>\n<\/p>\n<p>\u6839\u636e\u57fa\u56e0\u6167\u4e0d\u5b8c\u5168\u7edf\u8ba1\uff0cNMPA \u6279\u51c6\u7684\u4f34\u968f\u8bca\u65ad\u4ea7\u54c1\u8d85\u8fc740%\u96c6\u4e2d\u5728\u80ba\u764c\uff08\u5c24\u5176\u662f\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\uff09\uff0c\u8fd130%\u662f\u80a0\u764c\uff0c14%\u662f\u4e73\u817a\u764c\uff0c\u5c0f\u764c\u79cd\u5bf9\u5e94\u4ea7\u54c1\u6781\u5c11\u3002\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u4f34\u968f\u8bca\u65ad\u6807\u5fd7\u7269\u96c6\u4e2d\u5728T790M\u70b9\u7a81\u53d8\u3001ALK\/ROS1 \u57fa\u56e0\u878d\u5408\u7b49\u70ed\u70b9\u53d8\u5f02\u3002\u4ea7\u4e1a\u7aef\u4fa7\u91cd\u4ea7\u54c1\u51c6\u5165\u903b\u8f91\uff0c\u4e0e\u4e34\u5e8a\u9700\u6c42\u6709\u4e00\u5b9a\u7684\u5dee\u8ddd\uff0c\u9700\u8981\u8fdb\u4e00\u6b65\u7814\u53d1\u5dee\u5f02\u5316\u4f34\u968f\u8bca\u65ad\u53ca\u9776\u5411\u836f\u3002<\/p>\n<\/p>\n<p>\u76ee\u524dCDx\u7684\u83b7\u6279IVD\u4ea7\u54c1\u6570\u91cf\u6709\u9650\uff0c\u4e14\u9002\u5e94\u75c7\u96c6\u4e2d\uff0c\u56e0\u6b64\u5e02\u573a\u4e0a\u5927\u90e8\u5206\u4ecd\u4ee5 LDT\uff08\u5b9e\u9a8c\u5ba4\u81ea\u4e3b\u7814\u53d1\u7684\u68c0\u6d4b\u9879\u76ee\uff09\u5f62\u5f0f\u5728\u9662\u5916\u5f00\u5c55\uff0c\u5f53\u4e0b\u4e9f\u9700 LDT \u7684\u89c4\u8303\u6027\u76d1\u7ba1\u548c\u6307\u5bfc\u7ec6\u5219\u51fa\u53f0\u3002\u957f\u8fdc\u6765\u770b\uff0c\u80bf\u7624\u4f34\u968f\u8bca\u65ad\u4ea7\u54c1\u4f34\u968f\u5206\u5b50\u6807\u5fd7\u7269\u53d1\u73b0\u800c\u53d1\u5c55\uff0c\u5e02\u573a\u52a8\u529b\u4e4b\u4e00\u662f\u9776\u5411\u836f\u7814\u53d1\u5408\u4f5c\u3002FDA\u6279\u51c6\u7684 cobas EGFR Mutation Test v2\u3001FoundationOne CDx\u3001FoundationOne Liquid CDx\u3001ONCO\/Reveal Dx Lung &amp; Colon Cancer Assay \u7b49\u4f34\u968f\u8bca\u65ad\u8bd5\u5242\u53ef\u4ee5\u9488\u5bf9\u591a\u79cd\uff083-5 \u79cd\uff09\u6cbb\u7597\u836f\u7269\u4e14\u4e0d\u65ad\u6269\u5145\u8303\u56f4\uff0c\u4e3a\u540e\u7eed\u591a\u764c\u79cd\u3001\u6cdb\u764c\u79cd\u4f34\u968f\u8bca\u65ad\u53ca\u6cbb\u7597\u63d0\u4f9b\u4e86\u53c2\u8003\u3002<\/p>\n<\/p>\n<p>\u56db\u3001MRD\u68c0\u6d4b<\/p>\n<p>MRD \u6307\u7684\u662f\u5fae\u5c0f\u6b8b\u7559\u75c5\u7076\uff08Minimal Residual Disease, MRD\uff09\u6216\u5206\u5b50\u6b8b\u7559\u75c5\u7076\uff08Molecular Residual Disease\uff09\u3002\u65e9\u57282007\u5e74\uff0c\u82f1\u56fd\u8d1d\u5c14\u6cd5\u65af\u7279\u5973\u738b\u5927\u5b66\u7684Alexandra Irvine\u548cMary Mcmullin\u5bf9\u6b64\u505a\u8fc7\u63cf\u8ff0\uff0c\u5728\u6162\u6027\u9ad3\u7cfb\u767d\u8840\u75c5\u60a3\u8005\u63a5\u53d7\u6cbb\u7597\u540e\uff0c\u4e00\u5c0f\u90e8\u5206\u4f1a\u590d\u53d1\uff0c\u590d\u53d1\u6e90\u4e8e\u6301\u7eed\u5b58\u5728\u7684\u3001\u542b\u91cf\u6781\u4f4e\u3001\u4ec5\u80fd\u901a\u8fc7\u5206\u5b50\u68c0\u6d4b\u7684\u6076\u6027\u80bf\u7624\u7ec6\u80de\uff0c\u5373MRD\u3002<\/p>\n<\/p>\n<p>\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter\"><img decoding=\"async\" src=\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgCgakjS1chh6nMiaw3yR5PABe48S1vwQhp8VQbRlOo5WVib0ontCfLbGsibzPWNFDwLcWxWNyT7oC6qw.png\" alt=\"RmFicvQBAkgCgakjS1chh6nMiaw3yR5PABe48S1vwQhp8VQbRlOo5WVib0ontCfLbGsibzPWNFDwLcWxWNyT7oC6qw\"\/><\/figure><\/div>\n\n<\/p>\n<p>MRD\u68c0\u6d4b\u6709\u65f6\u4e5f\u5f52\u4e8e\u5e7f\u4e49\u7684\u4f34\u968f\u8bca\u65ad\uff0c\u4f46\u56e0\u4e3a\u4f5c\u4e3a\u56f4\u672f\u671f\u6cbb\u7597\u6548\u679c\u548c\u590d\u53d1\u76d1\u6d4b\u7684\u91cd\u8981\u65b9\u6cd5\uff0c\u5bf9\u65e9\u4e2d\u671f\u7684\u764c\u75c7\u60a3\u8005\u9884\u540e\u76d1\u6d4b\u975e\u5e38\u91cd\u8981\uff0c\u56e0\u6b64\u4e5f\u5355\u72ec\u6210\u4e3a\u4e00\u7c7b\u4ea7\u54c1\u3002MRD\u6bd4\u4f20\u7edf\u5f71\u50cf\u5b66\u53d1\u73b0\u75be\u75c5\u590d\u53d1\u5e73\u5747\u63d0\u524d5.2\u4e2a\u6708\u3002\u56db\u5ddd\u5927\u5b66\u534e\u897f\u533b\u9662\u80f8\u5916\u79d1\u7684\u5218\u4f26\u65ed\u6559\u6388\u5728Clinical Cancer Research\u4e0a\u53d1\u8868\u7684\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u524d\u77bb\u6027\u591a\u4e2d\u5fc3\u961f\u5217\u7814\u7a76\uff08330\u4f8bI-III\u671f\u60a3\u8005\uff0c950\u4efd\u8840\u6d46\u6837\u672c\uff09\u6210\u679c\u663e\u793a\uff0c\u672f\u540e3\u5929\u548c\/\u62161\u4e2a\u6708ctDNA \u9633\u6027\uff08\u5373MRD\u9633\u6027\uff09\u53ef\u5f3a\u6709\u529b\u5730\u9884\u6d4b\u75be\u75c5\u590d\u53d1\u98ce\u9669\uff08HR=11.1\uff09\uff0c\u6548\u679c\u4f18\u4e8e\u5305\u62ecTNM\u5206\u671f\u5728\u5185\u7684\u4e34\u5e8a\u75c5\u7406\u53d8\u91cf\u3002<\/p>\n<\/p>\n<p>\u5e94\u7528\u4e0a\uff0cMRD \u59cb\u4e8e\u8840\u6db2\u7624\u590d\u53d1\u68c0\u6d4b\uff0c\u9010\u6b65\u5f80\u5b9e\u4f53\u7624\u5e94\u7528\u3002<\/p>\n<\/p>\n<div>2016\u5e74\uff0c\u56fd\u9645\u9aa8\u9ad3\u7624\u5de5\u4f5c\u7ec4\u53d1\u5e03\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u4e2d MRD \u7684\u8bc4\u4f30\u5171\u8bc6\uff1b\u540c\u5e74\uff0cNCCN \u5728\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u7684\u4e34\u5e8a\u6307\u5357\u4e2d\u589e\u52a0\u4e86MRD \u68c0\u6d4b\uff1b<\/div>\n<div>2017\u5e74\uff0c\u65af\u5766\u798f\u5927\u5b66 Maximilian Diehn \u6559\u6388\u5728Cancer Discovery\u4e0a\u53d1\u8868\u57fa\u4e8ectDNA \u7684 MRD\u68c0\u6d4b\u6280\u672f\uff1b<\/div>\n<div>2018\u5e74\uff0cFDA \u6279\u51c6\u4e86\u9996\u4e2a\u57fa\u4e8e NGS\u7684MRD\u4ea7\u54c1\uff08Adaptive Biotechnologies \u7684 clonoSEQ\uff09\u7528\u4e8e\u6025\u6027\u6dcb\u5df4\u7ec6\u80de\u767d\u8840\u75c5\u6216\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u60a3\u8005\u7684MRD\u68c0\u6d4b\uff0c\u5e76\u4e8e2019\u5e74\u7eb3\u5165\u533b\u4fdd\uff1b<\/div>\n<div>2020\u5e74\uff0cFDA\u6b63\u5f0f\u53d1\u5e03MRD\u7528\u4e8e\u8840\u6db2\u7624\u836f\u7269\u548c\u751f\u7269\u5236\u54c1\u5f00\u53d1\u7684\u6307\u5357\uff1b<\/div>\n<div>2021\u5e74\uff0cNCCN\u7ed3\u80a0\u764c\u6307\u5357\u4e2d\u8ba4\u53ef\u57fa\u4e8ectDNA\u7684MRD\u68c0\u6d4b\u53ef\u6709\u6548\u5730\u8bc4\u4f30\u590d\u53d1\u98ce\u9669\uff1b<\/div>\n<div>2023\u5e74\u7ed3\u76f4\u80a0\u764c CSCO \u6307\u5357\u80af\u5b9a\u4e86MRD\u5728II\u671f\u7ed3\u76f4\u80a0\u764c\u5316\u7597\u51b3\u7b56\u53c2\u8003\u4ef7\u503c\u3002<\/div>\n<\/p>\n<p>MRD\u68c0\u6d4b\u5934\u90e8\u673a\u6784Natera\u7684Signatera \u4ea7\u54c1\u91c7\u7528\u201cWES+\u5b9a\u5236Panel\u201d\u7684Tumor informed 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