\u5728\u57fa\u56e0\u8bca\u7597\u7b49\u65b0\u5174\u6280\u672f\u8f6c\u5316\u548c\u5e94\u7528\u8fc7\u7a0b\u4e2d\uff0c\u4e0d\u89c4\u8303\u6ee5\u7528\u548c\u56e0\u564e\u5e9f\u98df\u90fd\u53ef\u80fd\u662f\u201c\u8fc7\u72b9\u4e0d\u53ca\u201d\u3002\u5982\u4f55\u5ba2\u89c2\u9762\u5bf9\u70ed\u70b9\u4e8b\u4ef6\uff0c\u5173\u7cfb\u5230\u5355\u4e2a\u673a\u6784\u751a\u81f3\u6574\u4e2a\u4ea7\u4e1a\u7684\u53d1\u5c55\u8282\u594f\uff0c\u66f4\u5173\u7cfb\u5230\u51b3\u7b56\u8005\u7684\u7406\u6027\u63aa\u65bd\uff0c\u4ee5\u53ca\u8001\u767e\u59d3\u5bf9\u5e38\u8bc6\u7684\u8ba4\u77e5\u3002<\/div>\n
\u00a0<\/div>\n
\u00a0\u4e00\u3001\u201cFDA\u8b66\u793a\u51fd\u201d\u4e8b\u4ef6\u7684\u8fd8\u539f<\/div>\n\n
\n![\"RmFicvQBAkgAP8kibZDiadZQa7dJbfxrZzulYviakicngaX8uHZe6y3ZTtFH2wnXtFQj0CMRjFAicsOVfAsb1yDP9HPw\"\/](\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgAP8kibZDiadZQa7dJbfxrZzulYviakicngaX8uHZe6y3ZTtFH2wnXtFQj0CMRjFAicsOVfAsb1yDP9HPw.png\")
<\/figure><\/div>\n\n
<\/figure><\/div>\n\n\u56fe1\uff1a\u5173\u4e8eFDA\u8b66\u793a\u57fa\u56e0\u516c\u53f8\u7684\u4fe1\u606f\u51fa\u5904\uff0c\u539f\u6807\u9898\u662f\u201cFDA\u5411\u4e00\u5bb6\u58f0\u79f0\u53ef\u4ee5\u9884\u6d4b\u60a3\u8005\u5bf9\u7279\u5b9a\u836f\u7269\u7684\u53cd\u5e94\u800c\u975e\u6cd5\u63a8\u5e7f\u7684\u67d0\u57fa\u56e0\u7ec4\u5b9e\u9a8c\u5ba4\u53d1\u51fa\u8b66\u544a\u51fd\u201d[1]\uff08\u6765\u6e90\/https:\/\/www.fda.gov\uff09<\/div>\n
FDA\u57282019\u5e744\u6708\u53d1\u51fa\u7684\u8fd9\u5c01\u516c\u5f00\u4fe1\u662f\u9488\u5bf9\u4e00\u5bb6\u53eb Inova \u57fa\u56e0\u7ec4\u5b9e\u9a8c\u5ba4\uff0c\u8ba4\u4e3a\u5176\u57fa\u56e0\u68c0\u6d4b\u7528\u836f\u6307\u5bfc\u4ea7\u54c1MediMap\u5b58\u5728\u8fc7\u5ea6\u5ba3\u4f20\u548c\u4e0d\u4e25\u8c28\u7684\u6d41\u7a0b\uff08\u89c1\u53c2\u8003\u8d44\u6599[2]\uff09\uff0c\u5f3a\u8c03\u4e86\u4e34\u5e8a\u8be2\u8bc1\u4ee5\u53ca\u4e34\u5e8a\u533b\u751f\u53c2\u4e0e\u7684\u91cd\u8981\u6027\uff0c\u4f46\u88ab\u4e2a\u522b\u5a92\u4f53\u8fc7\u5ea6\u89e3\u8bfb\u5bf9\u57fa\u56e0\u68c0\u6d4b\u65b9\u6cd5\u7684\u8d28\u7591\u3002<\/div>\n
\u00a0<\/div>\n
\u9996\u5148\uff0c\u6211\u4eec\u5148\u770b\u770bFDA\u8d28\u7591Inova\u57fa\u56e0\u7ec4\u5b9e\u9a8c\u5ba4\u7684\u5730\u65b9\uff1a<\/div>\n
1. FDA\u8ba4\u4e3a Inova \u57fa\u56e0\u7ec4\u5b9e\u9a8c\u5ba4\u5b98\u7f51\u4e0a\u5ba3\u4f20\u7684MediMap\u7b49\u57fa\u56e0\u68c0\u6d4b\u4ea7\u54c1\u6ca1\u6709\u83b7\u5f97FDA\u8425\u9500\u8bb8\u53ef\u6216\u6279\u51c6\u3002<\/div>\n
\u00a0<\/div>\n
2. FDA\u8ba4\u4e3aInova\u5b98\u7f51\u5b58\u5728\u4ee5\u4e0b\u8fc7\u5ea6\u5ba3\u4f20\uff1a<\/div>\n
1\uff09MediMap\u51cf\u5c11\u67d0\u4e9b\u836f\u7269\u7684\u526f\u4f5c\u7528\uff0c\u5e2e\u52a9\u60a3\u8005\u9009\u62e9\u6b63\u786e\u7684\u836f\u7269\u548c\u6b63\u786e\u7684\u5242\u91cf\uff0c\u901a\u8fc7\u6d4b\u8bd5\u60a3\u8005\u5bf9\u67d0\u4e9b\u75be\u75c5\u7684\u836f\u7269\u7684\u63a5\u53d7\u5ea6\u800c\u907f\u514d\u4e34\u5e8a\u5904\u65b9\u53cd\u590d\u8bd5\u9519\u3002<\/div>\n
2\uff09MediMap\u7684\u57fa\u56e0\u68c0\u6d4b\u62a5\u544a\u53ef\u4ee5\u63d0\u4f9b\u201c\u53ef\u884c\u7684\u548c\u4fe1\u606f\u6027\u7684\u6307\u5bfc\u201d\u4ee5\u53ca\u201c\u533b\u52a1\u5de5\u4f5c\u8005\u53ef\u4ee5\u81ea\u4fe1\u5730\u4f7f\u7528\u8fd9\u4e9b\u7ed3\u679c\u6765\u505a\u51fa\u6cbb\u7597\u51b3\u5b9a\u3002\u201d \u8fd9\u91ccFDA\u4e3e\u51fa\u4f8b\u5b50\uff0c\u4f8b\u5982CYP2C19\u57fa\u56e0\u578b\u5bf9\u836f\u7269\u4f9d\u4ed6\u666e\u4ed1\uff08escitalopram\u00a0\uff09\u548c\u820d\u66f2\u6797\uff08sertraline\uff09\u7684\u53cd\u5e94\u4e4b\u95f4\u7684\u5173\u7cfb\u5c1a\u672a\u5efa\u7acb\uff0c\u5e76\u672a\u5305\u542b\u5728FDA\u6279\u51c6\u7684\u836f\u7269\u6807\u7b7e\u63cf\u8ff0\u91cc\u3002<\/div>\n
3. MediMap\u57fa\u56e0\u68c0\u6d4b\u53ef\u7531\u5b9e\u9a8c\u5ba4\u7684\u533b\u751f\uff0c\u5e76\u5c06\u68c0\u6d4b\u7ed3\u679c\u76f4\u63a5\u63d0\u4f9b\u7ed9\u60a3\u8005\u3002\u8fd9\u53ef\u80fd\u5bfc\u81f4\u60a3\u8005\u5728\u6ca1\u6709\u533b\u751f\u53c2\u4e0e\u7684\u60c5\u51b5\u4e0b\u4e0d\u9002\u5f53\u5730\u589e\u52a0\u3001\u51cf\u5c11\u6216\u505c\u6b62\u836f\u7269\uff0c\u8fd9\u5bf9\u60a3\u8005\u7684\u5065\u5eb7\u5b89\u5168\u9020\u6210\u91cd\u5927\u98ce\u9669\u3002<\/div>\n
\u00a0<\/div>\n
FDA\u5f3a\u8c03\u4e86Inova\u516c\u53f8\u5b58\u5728\u7684\u4e09\u4e2a\u95ee\u9898\uff1a\u57fa\u56e0\u68c0\u6d4b\u7528\u836f\u6307\u5bfc\u4ea7\u54c1MediMap\u5e76\u672a\u83b7\u6279\uff0cMediMap\u7684\u836f\u7269\u7597\u6548\u8bc4\u4f30\u7b49\u529f\u80fd\u5938\u5927\uff0c\u4ee5\u53ca\u76f4\u63a5\u5411\u60a3\u8005\u63d0\u4f9b\u57fa\u56e0\u68c0\u6d4b\u62a5\u544a\u8fc7\u7a0b\u4e2d\u7f3a\u4e4f\u4e34\u5e8a\u533b\u751f\u7684\u53c2\u4e0e\u3002<\/div>\n
\u00a0<\/div>\n
\u8fd9\u4ef6\u65e7\u95fb\u8fd1\u671f\u88ab\u63d0\u51fa\u6765\uff0c\u548c\u53e6\u5916\u4e00\u6761\u4e0eMyriad\u7684\u65b0\u95fb\u6709\u5173\u3002\u6839\u636e\u5f6d\u535a\u793e\u62a5\u9053\uff08\u89c1\u53c2\u8003\u8d44\u6599[5]\uff09\uff0c\u5373FDA\u8981\u6c42Myriad\u516c\u53f8\u7684\u57fa\u56e0\u68c0\u6d4b\u4ea7\u54c1GeneSight\uff08\u8f85\u52a9\u6307\u5bfc\u6297\u6291\u90c1\u836f\u7684\u7528\u836f\uff09\u505a\u201c\u5fc5\u8981\u7684\u8c03\u6574\uff08requested changes\uff09\u201d\uff0cFDA\u8ba4\u4e3a\u9057\u4f20\u53d8\u5f02\u4e0e\u836f\u7269\u6548\u5e94\u4e4b\u95f4\u7684\u5173\u7cfb\u5c1a\u672a\u786e\u5b9a\u3002<\/div>\n
\u00a0<\/div>\n
\u00a0\u4e8c\u3001\u4e8b\u4ef6\u80cc\u540e\u7684\u7efc\u5408\u539f\u56e0\u53ca\u672c\u8d28\u00a0\u00a0<\/div>\n
\u66fe\u5c31\u804c\u4e8eINVITAE\u3001\u73b0\u4efb\u5b89\u5409\u5eb7\u5c14CEO\u7684\u674e\u9633\u535a\u58eb\u8c08\u5230\uff0c\u81ea\u4eceFDA\u5f53\u5e74\u628aLDT\u5207\u5206\u7ed9CMS\u7ba1\u7406\u4e4b\u540e\uff0c\u53ea\u8981\u4e0d\u6d89\u53ca\u7528\u836f\u63a8\u8350\u4e14\u5408\u4e4eCLIA\u4f53\u7cfb\uff0cFDA\u4e0d\u4f1a\u63d2\u624bLDT\u7ba1\u7406\u3002Myriad\u81ea\u4e0a\u4e16\u7eaa90\u5e74\u4ee3\u6210\u7acb\u4ee5\u6765\u6700\u4e3b\u8981\u7684\u4ea7\u54c1\u662f\u57fa\u4e8eLDT\u7684\u9057\u4f20\u6027\u4e73\u817a\u764c\u5375\u5de2\u764c(HBOC)\u57fa\u56e0\u8bca\u65ad\uff0c\u56e0\u4e3a\u4e0d\u6d89\u53ca\u7528\u836f\u7684\u6307\u5bfc\uff0c\u6240\u4ee5\u5e76\u4e0d\u5c5e\u4e8eFDA\u7ba1\u8f96\u3002\u4f46\u8be5\u4e1a\u52a1\u5728\u8fd1\u5e74\u53d7\u5230Invitae\u7b49\u65b0\u578b\u516c\u53f8\u7684\u51b2\u51fb\uff0c\u589e\u957f\u8d8b\u7f13\u30022016\u5e74Myriad\u901a\u8fc7\u6536\u8d2dAssurex\u83b7\u5f97\u5176\u7cbe\u795e\u7c7b\u836f\u7269\u57fa\u56e0\u7ec4\u4ea7\u54c1GeneSight\uff0c\u4e8e\u8fd1\u671f\u62ff\u5230\u5168\u7403\u6700\u5927\u533b\u4fdd\u516c\u53f8UnitedHealthcare\u7684\u533b\u4fdd\u8986\u76d6\u6279\u6587\uff0c\u9884\u8ba1\u572810\u67081\u65e5\u5f00\u59cb\u63a8\u5e7f\u3002\u5728FDA\u770b\u6765GeneSight\u7684\u8fc7\u5feb\u53d1\u5c55\u660e\u663e\u8fc7\u754c\u3002<\/div>\n
\u00a0<\/div>\n
\u7c7b\u4f3c\u7684\uff0c\u5bf9\u4e8eFDA\u8b66\u544aInova\u516c\u53f8\u4e8b\u4ef6\u800c\u8a00\uff0cFDA\u836f\u7269\u8bc4\u4f30\u4e2d\u5fc3\u4e3b\u4efbJanet Woodcock\u535a\u58eb\u8c08\u5230\u3002\u201c\u867d\u7136\u6211\u4eec\u81f4\u529b\u4e8e\u652f\u6301\u8fd9\u4e00\u9886\u57df\u7684\u521b\u65b0\uff0c\u4f46\u6211\u4eec\u4e5f\u5c06\u4fdd\u6301\u8b66\u60d5\uff0c\u9632\u8303\u6f5c\u5728\u7684\u98ce\u9669\uff0c\u56e0\u6b64\u53d1\u5e03\u8fd9\u5c01\u8b66\u544a\u4fe1\u3002\u201d<\/div>\n
\u7efc\u5408\u800c\u8a00\uff0c\u662f\u4e2a\u522b\u4f01\u4e1a\u4e3a\u4e86\u5e02\u573a\u53d1\u5c55\u800c\u5728\u4ea7\u54c1\u63a8\u5e7f\u4e0a\u8fc7\u754c\uff0c\u56e0\u6b64\u5e26\u6765\u76d1\u7ba1\u673a\u6784\u4e3a\u4e86\u9632\u8303\u98ce\u9669\u800c\u91c7\u53d6\u7684\u8b66\u793a\u63aa\u65bd\u3002<\/div>\n
\u00a0<\/div>\n
\u4e8b\u4ef6\u80cc\u540e\u7684\u672c\u8d28\u539f\u56e0\u5305\u62ec\u4e09\u70b9\uff1a\u4e00\u662f\u4ea7\u4e1a\u53d1\u5c55\u65e9\u671f\u9636\u6bb5\uff0c\u90e8\u5206\u4ea7\u4e1a\u673a\u6784\u5bf9\u9057\u4f20\u54a8\u8be2\u7b49\u4e13\u4e1a\u77e5\u8bc6\u7684\u4e0d\u4e86\u89e3\u3001\u7f3a\u4e4f\u656c\u754f\u6216\u8005\u5b58\u5728\u4fa5\u5e78\u5fc3\u7406\u3002\u540c\u65f6\uff0c\u800c\u76ee\u524d\u56fd\u5185\u4e3a\u4e86\u907f\u514d\u533b\u7597\u4e8b\u6545\u7ea0\u7eb7\uff0c\u57fa\u56e0\u68c0\u6d4b\u9001\u6837\u548c\u62a5\u544a\u53d1\u653e\u5f80\u5f80\u53d1\u751f\u5728\u60a3\u8005\u548c\u68c0\u6d4b\u673a\u6784\u4e4b\u95f4\uff0c\u518d\u8f97\u8f6c\u5c06\u4fe1\u606f\u4f20\u56de\u4e34\u5e8a\u533b\u751f\uff0c\u800c\u672a\u5f62\u6210\u5b8c\u6574\u7684\u6d41\u7a0b\u3002\u4e8c\u662f\u6781\u5ea6\u7f3a\u4e4f\u4e13\u95e8\u7684\u9057\u4f20\u54a8\u8be2\u4eba\u624d\uff0c\u7f8e\u56fd\u81ea80\u5e74\u4ee3\u521d\u671f\u5f00\u59cb\u9010\u6e10\u5efa\u7acb\u9057\u4f20\u54a8\u8be2\u4f53\u7cfb\uff08\u5305\u62ec\u5b66\u4f4d\u6559\u80b2\u548c\u4e13\u4e1a\u8d44\u683c\u8ba4\u5b9a\uff0c\u7ee7\u7eed\u6559\u80b2\u548c\u57f9\u8bad\u8003\u6838\uff09\uff0c\u800c\u6211\u56fd\u57282014\u5e74\u624d\u5c06\u533b\u5b66\u9057\u4f20\u79d1\u7eb3\u5165\u4e86\u4f4f\u9662\u533b\u5e08\u89c4\u8303\u5316\u57f9\u8bad\u7ba1\u7406\u4f53\u7cfb\u3002\u4e09\u662f\u57fa\u56e0\u6280\u672f\u5feb\u901f\u53d1\u5c55\u53ca\u4e34\u5e8a\u9700\u6c42\u5e26\u6765\u76d1\u7ba1\u7684\u96be\u5ea6\u3002\u5305\u62ecLDT\u5728\u5185\u4e0d\u540c\u6a21\u5f0f\u7ed9FDA\u4e5f\u5e26\u6765\u76d1\u7ba1\u56f0\u60d1\uff0c\u5728\u5bf9Inova\u5b9e\u9a8c\u5ba4\u7684\u8b66\u544a\u51fd\u4e2d\uff0cFDA\u5f3a\u8c03\uff0c\u867d\u7136\u5bf9LDT\u4e00\u822c\u4e0d\u4f1a\u5f3a\u5236\u6267\u884c\u4e0a\u5e02\u524d\u5ba1\u67e5\u3002\u00a0\u4f46\u9762\u5bf9\u91cd\u5927\u536b\u751f\u95ee\u9898\uff08\u98ce\u9669\uff09\u65f6\uff0c\u6267\u6cd5\u673a\u6784\u4ecd\u8981\u5bf9LDT\u884c\u4f7f\u81ea\u7531\u88c1\u91cf\u6743\u3002\u800c\u56fd\u5185\u81ea2014\u5e74\u53eb\u505cNIPT\uff08\u65e0\u521b\u4ea7\u524d\u57fa\u56e0\u68c0\u6d4b\uff09\u53c8\u534a\u5e74\u540e\u6062\u590d\uff0c\u5982\u4eca\u5904\u4e8e\u89c2\u671b\u9636\u6bb5\u3002<\/div>\n
\u00a0<\/div>\n
\u00a0\u4e09\u3001\u4ece\u4e2d\u53ef\u4ee5\u5b66\u5230\u4ec0\u4e48\uff1f\u5e94\u8be5\u505a\u4e9b\u4ec0\u4e48\uff1f<\/div>\n
\u4e00\u65b9\u9762\uff0c\u7b2c\u4e09\u65b9\u68c0\u6d4b\u673a\u6784\u5728\u4e34\u5e8a\u57fa\u56e0\u68c0\u6d4b\u5e94\u7528\u63a8\u5e7f\u9636\u6bb5\uff0c\u5e94\u91cd\u89c6\u4e25\u8c28\u7684\u4e34\u5e8a\u7814\u7a76\u548c\u4ea7\u54c1\u8d44\u8d28\uff0c\u5426\u5219\u53ef\u80fd\u91cd\u8e48\u201c\u9b4f\u5219\u897f\u4e8b\u4ef6\u201d\u7684\u8986\u8f99\u3002\u67d0\u533b\u79d1\u5927\u5b66\u526f\u4e66\u8bb0\u5728\u63a5\u53d7\u57fa\u56e0\u6167\u91c7\u8bbf\u8c08\u9053\uff1a\u201c\u57fa\u56e0\u68c0\u6d4b\u5e94\u7528\u4e34\u5e8a\u79bb\u4e0d\u5f00\u5faa\u8bc1\u533b\u5b66\u8bc1\u636e\uff0c\u9700\u8981\u6d4b\u5e8f\u540e\u7684\u79d1\u5b66\u6570\u636e\u89e3\u8bfb\u548c\u9057\u4f20\u54a8\u8be2\u201d\u3002\u65e0\u8bba\u662f\u4e0a\u5e02\u516c\u53f8\u8fd8\u662f\u521d\u521b\u673a\u6784\u5e94\u8be5\u8ba4\u8bc6\u5230\uff0c\u5f53\u524d\u7684\u57fa\u56e0\u884c\u4e1a\u53d1\u5c55\u4ecd\u4ee5\u6280\u672f\u4e3a\u6838\u5fc3\uff0c\u79d1\u5b66\u4e25\u8c28\u7684\u6001\u5ea6\u662f\u54c1\u724c\u57fa\u7840\uff0c\u5982\u679c\u5728\u5e02\u573a\u63a8\u5e7f\u4e2d\u8de8\u8d8a\u201c\u7ea2\u7ebf\u201d\u662f\u5bf9\u81ea\u6211\u548c\u884c\u4e1a\u7684\u6316\u5751\u3002\u4f8b\u5982\uff0cFDA\u7684\u8b66\u793a\u610f\u89c1\u968f\u4e4b\u5e26\u6765Myriad Genetics \u7684\u5e02\u503c\u201c\u84b8\u53d1\u201d43\uff05\uff0c\u80a1\u4ef7\u53d1\u751f\u81ea2000\u5e74\u4ee5\u6765\u6700\u5927\u7684\u5355\u65e5\u8dcc\u5e45\u3002<\/div>\n
\u00a0<\/div>\n
\u5f53\u7136\uff0c\u8fd9\u91cc\u4e5f\u5e94\u5ba2\u89c2\u4e86\u89e3\u5230\u56fd\u5185\u9ad8\u901a\u91cf\u57fa\u56e0\u68c0\u6d4b\u4ea7\u4e1a\u5316\u4e0d\u8fc712\u5e74\uff0c\u4e34\u5e8a\u57fa\u56e0\u68c0\u6d4b\u7684\u89c4\u6a21\u5316\u4e0d\u52305\u5e74\uff0c\u65b0\u5174\u4ea7\u4e1a\u53d1\u5c55\u53c8\u9700\u8981\u7ecf\u8fc7\u4e00\u4e2a\u9636\u6bb5\u7684\u8bd5\u9519\u548c\u5e02\u573a\u81ea\u6211\u8c03\u6574\u7684\u8fc7\u7a0b\uff0c\u7c7b\u4f3cFDA\u5b98\u65b9\u6587\u4ef6\u4e2d\u63d0\u5230\u4e34\u5e8a\u5904\u65b9\u8bd5\u9519\u4e00\u6837\u3002\u56fd\u5bb6\u536b\u751f\u90e8\u4e34\u68c0\u4e2d\u5fc3\u5ba4\u95f4\u8d28\u91cf\u8bc4\u4ef7\u4e13\u5bb6\u3001\u5409\u6797\u5927\u5b66\u7b2c\u4e00\u533b\u9662\u57fa\u56e0\u8bca\u65ad\u4e2d\u5fc3\u4e3b\u4efb\u59dc\u8273\u82b3\u8c08\u5230\uff1a\u201c\u6211\u4eec\u4e34\u5e8a\u5faa\u8bc1\u533b\u5b66\u5927\u91cf\u8bc1\u636e\u8bc1\u5b9e\u57fa\u56e0\u68c0\u6d4b\u5728\u9057\u4f20\u6027\u80bf\u7624\u3001\u80bf\u7624\u9776\u5411\u836f\u7b5b\u9009\u3001\u514d\u75ab\u6cbb\u7597\u6307\u5bfc\u7b49\u6709\u5f88\u91cd\u8981\u7684\u6307\u5bfc\u4f5c\u7528\u3002\u4efb\u4f55\u4e00\u79cd\u68c0\u6d4b\u6280\u672f\u603b\u4f1a\u6709\u81ea\u5df1\u7684\u4f18\u7f3a\u70b9\uff0c\u5c31\u770b\u6211\u4eec\u600e\u4e48\u53bb\u8fd0\u7528\u3002\u201d<\/div>\n
\u00a0<\/div>\n
\u5176\u6b21\uff0c\u4e00\u9879\u65b0\u5174\u6280\u672f\u5e94\u7528\u8fc7\u7a0b\uff0c\u5efa\u7acb\u5b8c\u6574\u7684\u4f9b\u5e94\u94fe\u662f\u4fdd\u969c\u8d28\u91cf\u7684\u524d\u63d0\uff0c\u76ee\u524d\u4e34\u5e8a\u57fa\u56e0\u68c0\u6d4b\u4ea7\u4e1a\u94fe\u73af\u8282\u6700\u7f3a\u4e4f\u7684\u662f\u8d28\u91cf\u63a7\u5236\u548c\u9057\u4f20\u54a8\u8be2\u4eba\u624d\u3002\u901a\u5e38\u8c08\u5230\u8d28\u63a7\uff0c\u4f1a\u56de\u5230\u8001\u751f\u5e38\u8c08\u7684\u6570\u636e\u5171\u4eab\u3001\u5efa\u7acb\u6570\u636e\u5e93\u548c\u6807\u51c6\u7684\u8bdd\u9898\u3002\u5728\u5f53\u524d\u8fd9\u65b9\u9762\u4ecd\u5728\u5b8c\u5584\u8fc7\u7a0b\u4e2d\uff0c\u7ed3\u5408\u76f8\u5173\u51b3\u7b56\u673a\u6784\u3001\u5b66\u4f1a\u3001\u4ea7\u4e1a\u8054\u76df\u7684\u529b\u91cf\u53d1\u5e03\u57fa\u7840\u7684\u3001\u5c40\u90e8\u7684\u8d28\u91cf\u63a7\u5236\u89c4\u8303\u6216\u6307\u5357\u6216\u6709\u4e00\u5b9a\u7684\u53ef\u6267\u884c\u5316\uff0c\u5305\u62ec\u4ece\u5b98\u65b9\u89d2\u5ea6\u63a8\u52a8\u548c\u652f\u6301\u76f8\u5173\u4e34\u5e8a\u8868\u578b\u4e0e\u57fa\u56e0\u578b\u5173\u8054\u6570\u636e\u5e93\u7684\u5efa\u8bbe\u5f62\u6210\u8be2\u8bc1\u8bc1\u636e\uff0c\u4ece\u7406\u5ff5\u548c\u610f\u8bc6\u4e0a\u63d0\u9ad8\u884c\u4e1a\u7684\u91cd\u89c6\uff0c\u800c\u540e\u9010\u6e10\u5b8c\u5584\u3002<\/div>\n
\u00a0<\/div>\n
\u5728\u9057\u4f20\u54a8\u8be2\u4eba\u624d\u4e0a\uff0c\u76ee\u524d\u5e02\u9762\u4e0a\uff0c\u6709\u8d3a\u6797\u6559\u6388\u3001\u9ec4\u5c1a\u5fd7\u6559\u6388\u3001\u7941\u9e23\u6559\u6388\u7b49\u4e13\u5bb6\u9886\u8854\u7684\u516d\u4e2a\u4e0d\u540c\u673a\u6784\u5b9a\u671f\u53ec\u5f00\u7684\u9057\u4f20\u54a8\u8be2\u57f9\u8bad\u73ed\uff0c\u89e3\u51b3\u4e86\u4e00\u90e8\u5206\u95ee\u9898\u57fa\u7840\u4e0a\uff0c\u5efa\u8bae\u63d0\u9ad8\u5165\u95e8\u95e8\u69db\u3001\u5ba1\u6838\u8d44\u8d28\u4ee5\u53ca\u5f00\u8bbe\u9891\u6b21\uff0c\u5f53\u7136\uff0c\u8fd9\u91cc\u4f9d\u8d56\u76f8\u5173\u90e8\u95e8\u7684\u6295\u5165\u548c\u652f\u6301\uff0c\u8ba9\u6c11\u95f4\u7684\u9057\u4f20\u54a8\u8be2\u5f97\u5230\u5b98\u65b9\u8ba4\u53ef\u548c\u63a8\u52a8\uff0c\u6bd4\u5982\u8bbe\u7acb\u4e34\u5e8a\u57fa\u56e0\u68c0\u6d4b\u76f8\u5173\u7684\u4eba\u624d\u8d44\u8d28\u8ba4\u5b9a\uff0c\u63a8\u5e7f\u76f8\u5173\u7684\u5b66\u4f4d\u6559\u80b2\u7b49\u3002\u6b64\u5916\uff0c\u4e5f\u5efa\u8bae\u5404\u533b\u7597\u673a\u6784\u5bf9\u4e34\u5e8a\u57fa\u56e0\u68c0\u6d4b\u7684\u533b\u52a1\u5de5\u4f5c\u8005\u4e3e\u884c\u5b9a\u671f\u3001\u957f\u671f\u7684\u57fa\u56e0\u79d1\u666e\u57f9\u8bad\uff0c\u63d0\u9ad8\u57fa\u672c\u7684\u9274\u522b\u80fd\u529b\u3002<\/div>\n
\u00a0<\/div>\n
\u6700\u540e\u4e00\u65b9\u9762\uff0c\u5728\u53d1\u5c55\u9f13\u52b1\u521b\u65b0\u9636\u6bb5\uff0c\u5982\u4f55\u8f85\u52a9\u51b3\u7b56\u673a\u6784\u5efa\u7acb\u53ef\u843d\u5730\u7684\u89c4\u8303\u653f\u7b56\uff0c\u662f\u6240\u6709\u8eab\u5904\u884c\u4e1a\u4e2d\u5e94\u8be5\u601d\u8003\u7684\u3002\u56e0\u4e3a\u5b9e\u7528\u3001\u53ef\u666e\u53ca\u7684\u884c\u4e1a\u653f\u7b56\u6e90\u4e8e\u884c\u4e1a\u63a2\u7d22\u89e3\u51b3\u65b9\u6848\u7684\u57fa\u7840\u3002\u6bd4\u5982\u6d88\u8d39\u7ea7\u57fa\u56e0\u68c0\u6d4b\u548c\u4e34\u5e8a\u7ea7\u57fa\u56e0\u68c0\u6d4b\u7684\u754c\u9650\uff0c\u4e34\u5e8a\u9662\u5185\u68c0\u6d4b\u3001LDT\u548c\u7b2c\u4e09\u65b9\u9001\u68c0\u7684\u6d41\u7a0b\u7684\u7ea6\u675f\u7b49\uff0c\u4ecd\u9700\u884c\u4e1a\u5185\u90e8\u5efa\u7acb\u57fa\u672c\u5171\u8bc6\u3002<\/div>\n
\u00a0<\/div>\n
\u5b89\u5409\u5eb7\u5c14CEO\u7684\u674e\u9633\u535a\u58eb\u8c08\u5230\uff0c\u6b64\u6b21\u53d1\u51fa\u8b66\u544a\u5728\u610f\u6599\u4e4b\u4e2d\uff0c\u4f46\u4e0d\u4ee3\u8868FDA\u5c06\u5bf9\u5b66\u672f\u548c\u4e34\u5e8a\u4e0a\u65e9\u5df2\u6210\u719f\u4e14\u4e0d\u6d89\u53ca\u7528\u836f\u6307\u5bfc\u7684\u8bca\u65ad\u7c7bLDT\u6539\u53d8\u76d1\u7ba1\u7b56\u7565\u3002\u57fa\u56e0\u6167\u83b7\u6089\uff0c\u56fd\u5185\u4e5f\u6b63\u5728\u63a2\u7d22\u5efa\u7acbLDT\u6a21\u5f0f\u3002\u76ee\u524d\u56fd\u5185\u83b7\u6279\u7684\u56db\u5bb6NGS\u8bca\u65ad\u8bd5\u5242\u76d2\uff0c\u5747\u662f\u9488\u5bf9\u4e8e\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u7684\u8f85\u52a9\u8bca\u65ad\u7684\u6570\u4e2a\u57fa\u56e0\u7684\u5c0fPanel\uff0c\u800cFDA\u5df2\u7ecf\u53d1\u5c55\u5bf9MSK\u3001FMI\u7b49\u66f4\u591a\u6570\u91cf\u7684\u57fa\u56e0\u5927Panel\u7684\u8ba4\u8bc1\uff0c\u8fd9\u662f\u5168\u7403\u8303\u56f4\u5185\u57fa\u56e0\u6280\u672f\u5e94\u7528\u7684\u53d1\u5c55\u8d8b\u52bf\u3002<\/div>\n
\u00a0<\/div>\n
\u6b64\u6b21\u4e8b\u4ef6\u662f\u53d1\u5c55\u521b\u65b0\u4e2d\u7684\u8b66\u793a\uff0c\u4e00\u65b9\u9762\u662f\u5bf9\u4e34\u5e8a\u57fa\u56e0\u68c0\u6d4b\u53d1\u5c55\u7684\u7ea0\u504f\uff0c\u53e6\u4e00\u65b9\u9762\u6b63\u5982FDA\u8bbe\u5907\u548c\u653e\u5c04\u5065\u5eb7\u4e2d\u5fc3\u4e3b\u4efbJeff Shuren\u6240\u8bf4\u3002\u00a0\u662f\u56e0\u4e3a\u6d88\u8d39\u8005\u8d8a\u6765\u8d8a\u591a\u5730\u63a5\u53d7\u57fa\u56e0\u68c0\u6d4b\u6765\u66f4\u597d\u5730\u4e86\u89e3\u60a3\u75be\u75c5\u7684\u98ce\u9669\u3002\u76d1\u7ba1\u4e5f\u6e90\u4e8e\u968f\u7740\u4e34\u5e8a\u57fa\u56e0\u68c0\u6d4b\u7684\u666e\u60e0\u6027\u6b63\u9010\u6e10\u63d0\u9ad8\u3002<\/div>\n
\u00a0<\/div>\n
\u6539\u9769\u8fdb\u5165\u7b2c\u4e8c\u9636\u6bb5\uff0c\u4fa7\u91cd\u70b9\u5df2\u7ecf\u4ece\u6a21\u5f0f\u521b\u65b0\u5230\u6280\u672f\u521b\u65b0\uff0c\u6d51\u6c34\u6478\u9c7c\u7684\u7a97\u53e3\u671f\u5173\u95ed\u4e86\uff0c\u57fa\u7840\u7814\u7a76\u3001\u4e34\u5e8a\u8f6c\u5316\u548c\u4ea7\u4e1a\u521b\u65b0\u662f\u672a\u6765\u7684\u4e3b\u89d2\u3002\u6211\u4eec\u5e94\u8be5\u5728\u53d1\u5c55\u4e2d\u5e94\u4fdd\u6301\u4e25\u8c28\u548c\u5ba1\u614e\uff0c\u540c\u65f6\u4e5f\u4e0d\u56e0\u564e\u5e9f\u98df\uff0c\u5728\u5206\u6790\u95ee\u9898\u548c\u591a\u65b9\u534f\u4f5c\u5c0f\u6b65\u5feb\u8dd1\uff0c\u5728\u51cf\u5c11\u6539\u9769\u5e26\u6765\u7684\u9635\u75db\u540c\u65f6\u6210\u4e3a\u5bf9\u5916\u5f00\u653e\u3001\u5bf9\u5185\u521b\u65b0\u4e2d\u7684\u5efa\u8bbe\u8005\u6216\u8005\u6865\u6881\u3002<\/div>\n
\u00a0<\/div>\n
\u53c2\u8003\u8d44\u6599\uff1a<\/div>\n
1\uff09https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-issues-warning-letter-genomics-lab-illegally-marketing-genetic-test-claims-predict-patients<\/div>\n
2\uff09https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/inova-genomics-laboratory-577422-04042019<\/div>\n
3\uff09https:\/\/www.fda.gov\/medical-devices\/safety-communications\/fda-warns-against-use-many-genetic-tests-unapproved-claims-predict-patient-response-specific<\/div>\n
4\uff09https:\/\/news.yahoo.com\/fda-warns-testing-companies-don-083050594.html<\/div>\n
5)\u00a0\u00a0https:\/\/www.allurnews.com\/en-us\/2019\/08\/15\/dna-test-for-antidepressants-raises-questions-from-fda\/<\/div>\n
6\uff09 \u300a\u8f6c\u300b\u8bbf\u5434\u67cf\u6797\uff1a\u7f8e\u56fd\u4e34\u5e8a\u9057\u4f20\u54a8\u8be2\u4f53\u7cfb<\/div>\n
\uff08\u5c01\u9762\u56fe\u6765\u6e90\uff1amanufacturing chemist\uff09<\/div>\n
\u00a0<\/div>\n
\u58f0\u660e\uff1a\u4ee5\u4e0a\u6587\u7ae0\u4e3a\u884c\u4e1a\u76f8\u5173\u8d44\u8baf\u6216\u5206\u6790\u6587\u7ae0\uff0c\u4ec5\u4ee3\u8868\u4e2a\u4eba\u89c2\u70b9\uff0c\u4ec5\u4f9b\u7814\u7a76\u53c2\u8003\uff0c\u4e0d\u4f5c\u4e3a\u6295\u878d\u8d44\u53ca\u533b\u7597\u7b49\u51b3\u7b56\u4f9d\u636e\uff1b\u7f16\u8f91\u540e\u7684\u6587\u7ae0\u7684\u77e5\u8bc6\u7248\u6743\u5c5e\u4e8e\u57fa\u56e0\u6167\uff0c\u673a\u6784\u8f6c\u8f7d\u8bf7\u5728\u6587\u7ae0\u4f5c\u8005\u4ee5\u53ca\u6b63\u6587\u9996\u884c\u6ce8\u660e\u51fa\u5904\uff0c\u6b22\u8fce\u4e2a\u4eba\u8f6c\u53d1\u81f3\u670b\u53cb\u5708\u53ca\u7fa4\u5206\u4eab\u3002<\/div>\n
\u00a0<\/div>\n
\u00a0\u62d3\u5c55\u9605\u8bfb\u00a0<\/div>\n
2019\u5e74\u534a\u7a0b\uff0c\u57fa\u56e0\u4ea7\u4e1a\u7684\u9ece\u660e\u524d\u9759\u6084\u6084\uff08\u4e0a\uff09<\/a><\/div>\n
\u4e00\u56fe\u901f\u89c8CSCO 2019 \u65e5\u7a0b\u5730\u56fe<\/a><\/div>\n
\u00a0<\/div>\n
\u00a0\u6b22\u8fce\u6295\u7a3f\u00a0<\/div>\n
\u8bf7\u4ee5\u201c\u6295\u7a3f-\u59d3\u540d-\u65e5\u671f\u201d\u4e3a\u4e3b\u9898<\/div>\n
\u53d1\u9001Word\u6587\u4ef6\u81f3info@genonet.cn<\/div>\n
\u6765\u7a3f\u901a\u8fc7\u540e\u53ef\u7f72\u540d\u53d1\u5e03\uff0c\u7ecf\u4e3b\u7f16\u6da6\u8272<\/div>\n
\u00a0<\/div>\n
\u00a0\u57fa\u56e0\u6167\u62db\u8058\u00a0<\/div>\n
\u57fa\u56e0\u884c\u4e1a\u6b63\u5728\u7ecf\u538615\u5e74\u524d\u7684\u4e92\u8054\u7f51\u5468\u671f\uff0c\u6210\u4e3a\u4e0b\u4e00\u4e2a\u6d6a\u6f6e<\/div>\n
\u8d44\u6e90\u914d\u7f6e\u4ece\u6492\u8c46\u6210\u5175\u5230\u767e\u5ddd\u5165\u6d77\u7684\u96c6\u7fa4\u5316<\/div>\n
\u4fe1\u606f\u6218\u7565\u662f\u6b64\u65f6\u7684\u9996\u8981\u5143\u7d20<\/div>\n
\u57fa\u56e0\u6167\u9080\u8bf7\u60a8\u6210\u4e3a\u884c\u4e1a\u5206\u6790\u4e13\u5bb6\uff0c\u5148\u4e00\u6b65\u770b\u89c1\u672a\u6765<\/div>\n
\u5982\u679c\u60a8\u5728\u65b0\u5a92\u4f53\u3001\u57fa\u56e0\u5e02\u573a\u7b49\u67091+\u5e74\u7ecf\u9a8c\uff0c\u70ed\u7231\u57fa\u56e0\u884c\u4e1a\uff0c\u6b22\u8fce\u5c06\u7b80\u5386\u6295\u9012\u5230\uff1ainfo@genonet.cn<\/div>\n
\u52a0\u5165\u57fa\u56e0\u6167\u8bfb\u8005\u7fa4\u6216\u5408\u4f5c<\/div>\n
\u6dfb\u52a0\u5fae\u4fe1 jiyinhui_1\uff0c\u53e3\u4ee4\uff1a\u5355\u4f4d\/\u804c\u4f4d\/\u59d3\u540d\uff08\u901a\u8fc7\u540e\u8d50\u540d\u7247\uff09<\/div>\n
\u00a0<\/div>\n
\u3010\u5173\u4e8e\u57fa\u56e0\u6167\u3011<\/div>\n
\u57fa\u56e0\u6167\u662f\u4e00\u5bb6\u57fa\u56e0\u548c\u6570\u5b57\u751f\u547d\u5065\u5eb7\u4ea7\u4e1a\u54a8\u8be2\u673a\u6784\uff0c\u5efa\u7acb\u4e86\u884c\u4e1a\u667a\u5e93\u3001\u4f01\u4e1a\u5e93\u548c\u4f20\u5a92\u5e73\u53f0\uff0c\u63d0\u4f9b\u4e13\u4e1a\u7684\u54c1\u724c\u3001\u4fe1\u606f\u53ca\u54a8\u8be2\u670d\u52a1\uff0c\u5e2e\u52a9\u5408\u4f5c\u4f19\u4f34\u5148\u4e00\u6b65\u770b\u89c1\u672a\u6765\u3002<\/div>\n
\u3010\u90e8\u5206\u8363\u8a89\u3011<\/div>\n
\u56fd\u5bb6\u53d1\u6539\u59d4\u300a2019\u5e74\u6218\u7565\u6027\u65b0\u5174\u4ea7\u4e1a\u53d1\u5c55\u5c55\u671b\u300b\u7f16\u59d4<\/div>\n
\u5168\u56fd\u536b\u751f\u4ea7\u4e1a\u4f01\u4e1a\u7ba1\u7406\u534f\u4f1a\u7cbe\u51c6\u533b\u7597\u5206\u4f1a\u7406\u4e8b<\/div>\n
\u54c8\u5c14\u6ee8\u5de5\u4e1a\u5927\u5b66\uff08\u6df1\u5733\uff09\u300a\u751f\u7269\u4ea7\u4e1a\u5206\u6790\u300b\u8bfe\u7a0b\u5408\u4f5c<\/div>\n
\u201c\u5341\u4e09\u4e94\u91cd\u70b9\u51fa\u7248\u56fe\u4e66\u201d\u300a\u4e34\u5e8a\u751f\u7269\u6837\u672c\u5e93\u63a2\u7d22\u4e0e\u5b9e\u8df5<\/a>\u300b\u7f16\u59d4<\/div>\n
\u5e7f\u4e1c\u7701\u7cbe\u51c6\u533b\u5b66\u5b66\u4f1a\u653f\u7b56\u7814\u7a76\u5206\u4f1a\u5e38\u59d4<\/div>\n
\u6df1\u5733\u5e02\u5065\u5eb7\u4ea7\u4e1a\u53d1\u5c55\u4fc3\u8fdb\u4f1a\u526f\u4f1a\u957f\u5355\u4f4d<\/div>\n
\u53d1\u5e03\u4e86\u300a2019 \u5e74\u57fa\u56e0\u884c\u4e1a\u62a5\u544a\u300b<\/a>\u7b49\u6743\u5a01\u884c\u4e1a\u62a5\u544a<\/div>\n
\u53c2\u4e0e\u7ec4\u7ec7\u300a\u4e34\u5e8a\u57fa\u56e0\u68c0\u6d4b\u62a5\u544a\u89c4\u8303\u4e0e\u57fa\u56e0\u68c0\u6d4b\u884c\u4e1a\u5171\u8bc6\u300b<\/a>\u53ca\u76f8\u5173\u56e2\u4f53\u6807\u51c6<\/div>\n
\u53d7\u9080\u53c2\u4e0e\u534e\u897f\u533b\u9662\u3001\u534e\u5927\u3001Illumina\u3001\u626c\u5b50\u79d1\u521b\u7b49\u4e3b\u529e\u7684\u5927\u4f1a\u505a\u4ea7\u4e1a\u5206\u6790\u4e3b\u9898\u62a5\u544a<\/a><\/div>\n
\u4e3b\u529e\u9996\u5c4a\u6570\u5b57\u5065\u5eb7\u79c1\u8463\u4f1a<\/a><\/div>\n
\u4e3b\u529e\u9996\u5c4a\u7ca4\u6e2f\u6fb3\u5927\u6e7e\u533a\u751f\u547d\u5065\u5eb7\u521b\u65b0\u8bba\u575b<\/a><\/div>\n
\u534f\u529e\u7b2c\u4e00\u5c4a<\/a>\u548c\u7b2c\u4e8c\u5c4a\u57fa\u56e0\u68c0\u6d4b\u8054\u76df\u5927\u4f1a<\/a><\/div>\n
\u6b22\u8fce\u56ed\u533a\u3001\u91d1\u878d\u673a\u6784\u3001\u884c\u4e1a\u5b66\u4f1a\u4ee5\u53ca\u4ea7\u4e1a\u673a\u6784\u7b49\u5408\u4f5c\u3002\u57fa\u56e0\u6167\u6765\u81ea\u4e8e\u4ea7\u4e1a\uff0c\u670d\u52a1\u4e8e\u4ea7\u4e1a\u53d1\u5c55\u548c\u8de8\u754c\u878d\u5408\u3002\uff08400-088-7466\uff0cinfo@genonet.cn\uff09\u3002<\/div>\n\n
\n![\"RmFicvQBAkgDwDDlibn6LGMERd60A1XgibkVTEVrPEb1EoTK1HnjticKMtrzWS4eyuZgibs4H2ErBL6cp0GRTKvEAkg\"\/](\"https:\/\/www.geneclub.net.cn\/wp-content\/uploads\/images\/RmFicvQBAkgDwDDlibn6LGMERd60A1XgibkVTEVrPEb1EoTK1HnjticKMtrzWS4eyuZgibs4H2ErBL6cp0GRTKvEAkg.jpeg\")
<\/figure><\/div>","protected":false},"excerpt":{"rendered":"
<\/figure><\/div>","protected":false},"excerpt":{"rendered":"\u201c\u9020\u8c23\u4e00\u5f20\u5634\uff0c\u8f9f\u8c23\u8dd1\u65ad\u817f\u201d<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9],"tags":[1810],"class_list":["post-9228","post","type-post","status-publish","format-standard","hentry","category-industryresearch","tag-1810"],"_links":{"self":[{"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/posts\/9228","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=9228"}],"version-history":[{"count":3,"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/posts\/9228\/revisions"}],"predecessor-version":[{"id":13946,"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/posts\/9228\/revisions\/13946"}],"wp:attachment":[{"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/media?parent=9228"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/categories?post=9228"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.geneclub.net.cn\/index.php\/wp-json\/wp\/v2\/tags?post=9228"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}