{"id":436020,"date":"2026-05-15T22:00:00","date_gmt":"2026-05-15T14:00:00","guid":{"rendered":"https:\/\/pingtungtimes.com.tw\/?p=436020"},"modified":"2026-05-15T22:00:00","modified_gmt":"2026-05-15T14:00:00","slug":"datar-cancer-genetics-%e7%9a%84-celldx-tissue-%e7%8d%b2%e5%be%97%e7%be%8e%e5%9c%8b-fda-%e6%a0%b8%e5%87%86%ef%bc%8c%e7%82%ba%e8%a9%b2%e9%a0%85%e5%88%a9%e7%94%a8-dna-%e8%88%87-rna-%e9%80%b2%e8%a1%8c","status":"publish","type":"post","link":"https:\/\/pingtungtimes.com.tw\/?p=436020","title":{"rendered":"Datar Cancer Genetics \u7684 CellDx-Tissue \u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u70ba\u8a72\u9805\u5229\u7528 DNA \u8207 RNA \u9032\u884c\u7684\u5be6\u9ad4\u816b\u7624\u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u6aa2\u6e2c\u5beb\u4e0b\u91cc\u7a0b\u7891"},"content":{"rendered":"<div>\n<p><i>\u662f\u6b21\u6838\u51c6\u8a8d\u5b9a\u4e86 Cell<sup>Dx<\/sup>-Tissue \u7684 DNA \u8207 RNA \u96d9\u5206\u6790\u7269\u5de5\u4f5c\u6d41\u7a0b\uff0c\u6db5\u84cb 517 \u500b\u8207\u764c\u75c7\u76f8\u95dc\u7684\u57fa\u56e0\uff0c\u4e26\u80fd\u4ee5 RNA \u5c64\u7d1a\u8b49\u64da\u5075\u6e2c ALK\u3001RET \u8207 ROS1 \u7b49\u95dc\u9375\u878d\u5408\u57fa\u56e0<\/i><\/p>\n<p><span class=\"legendSpanClass\">\u5370\u5ea6\u7d0d\u897f\u514b<\/span><span class=\"legendSpanClass\">2026\u5e745\u670815\u65e5<\/span> \/\u7f8e\u901a\u793e\/ &#8212; \u5168\u7403\u7cbe\u6e96\u816b\u7624\u91ab\u5b78\u516c\u53f8 Datar Cancer Genetics (DCG) \u4eca\u65e5\u5ba3\u4f48\uff0c\u5176\u9069\u7528\u65bc\u6240\u6709\u5be6\u9ad4\u816b\u7624\u3001\u4ee5\u7d44\u7e54\u70ba\u57fa\u790e\u7684\u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790 (comprehensive genomic profiling\uff0c\u7c21\u7a31 CGP) \u6aa2\u6e2c\u65b9\u6cd5 Cell<sup>Dx<\/sup>-Tissue\uff0c\u5df2\u7372\u5f97\u7f8e\u570b\u98df\u54c1\u53ca\u85e5\u7269\u7ba1\u7406\u5c40\uff08US Food and Drug Administration\uff0c\u7c21\u7a31\u7f8e\u570b FDA\uff09\u7684\u6838\u51c6\u3002<\/p>\n<div id=\"prni_dvprnejpg4caeleft\" dir=\"ltr\" style=\"TEXT-ALIGN: center; WIDTH: 100%\">   <span>CellDx-Tissue- \u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u6aa2\u6e2c<\/span>  <\/div>\n<p>\u662f\u6b21\u6838\u51c6\u9032\u4e00\u6b65\u978f\u56fa DCG \u5728\u63d0\u4f9b\u7a81\u7834\u6027\u5e73\u53f0\u65b9\u9762\u7684\u5730\u4f4d\uff0c\u8a72\u5e73\u53f0\u65e8\u5728\u5354\u52a9\u5168\u7403\u816b\u7624\u79d1\u91ab\u751f\u6839\u64da\u5c08\u696d\u6307\u5f15\u4f5c\u51fa\u500b\u4eba\u5c08\u5c6c\u7684\u81e8\u5e8a\u7ba1\u7406\u6c7a\u7b56\uff0c\u4e26\u4e14\u8207\u8a72\u516c\u53f8\u65e9\u524d\u91dd\u5c0d\u5176\u6db2\u614b\u5207\u7247\u5e73\u53f0\u800c\u7372\u5f97\u7684\u7f8e\u570b FDA \u7a81\u7834\u6027\u91ab\u7642\u5668\u6750\u8a8d\u5b9a (US FDA Breakthrough Device Designations) \u4e92\u76f8\u88dc\u8db3\u3002<\/p>\n<p><b>\u95dc\u65bc Cell<sup>Dx<\/sup>-Tissue<\/b><\/p>\n<p>Cell<sup>Dx<\/sup>-Tissue \u662f\u4e00\u7a2e\u5b9a\u6027\u9ad4\u5916\u8a3a\u65b7 (IVD) \u6aa2\u6e2c\uff0c\u5b83\u5229\u7528\u6a19\u9776\u5f0f\u6b21\u4e16\u4ee3\u5b9a\u5e8f (NGS) \u6280\u8853\uff0c\u5c0d\u5f9e\u798f\u723e\u99ac\u6797\u56fa\u5b9a\u77f3\u881f\u5305\u57cb (FFPE) \u5be6\u9ad4\u816b\u7624\u60a3\u8005\u7684\u816b\u7624\u7d44\u7e54\u4e2d\u5206\u96e2\u7684 DNA \u53ca RNA \u9032\u884c\u5206\u6790\u3002 \u6b64\u6aa2\u6e2c\u5206\u6790 517 \u500b\u8207\u764c\u75c7\u76f8\u95dc\u7684\u57fa\u56e0\uff0c\u76ee\u7684\u5728\u65bc\u63d0\u4f9b\u6709\u95dc\u9ad4\u7d30\u80de\u55ae\u6838\u82f7\u9178\u8b8a\u7570 (SNV)\u3001\u5c0f\u7247\u6bb5\u63d2\u5165\u548c\u7f3a\u5931 (InDels)\u3001<i>ERBB2<\/i> \u57fa\u56e0\u64f4\u589e\u8207\u6d89\u53ca <i>ALK\u3001RET<\/i> \u548c <i>ROS1<\/i> \u7684\u57fa\u56e0\u878d\u5408\u8cc7\u8a0a\u3002 Cell<sup>Dx<\/sup>-Tissue \u70ba\u55ae\u4e00\u5be6\u9a57\u5ba4\u6aa2\u6e2c\uff0c\u7531 Datar Cancer Genetics \u65d7\u4e0b\u7372\u5f97 CAP \u53ca CLIA \u8a8d\u8b49\u7684\u5be6\u9a57\u5ba4\u9032\u884c\u3002<\/p>\n<p><b>\u91cd\u8981\u610f\u7fa9<\/b><\/p>\n<p>\u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u5df2\u6210\u70ba\u5be6\u9ad4\u816b\u7624\u81e8\u5e8a\u7ba1\u7406\u7684\u6838\u5fc3\u7d44\u6210\u90e8\u5206\uff0c\u5354\u52a9\u81e8\u5e8a\u91ab\u751f\u5728\u591a\u7a2e\u764c\u75c7\u985e\u578b\u4e2d\u5168\u9762\u89e3\u6790\u816b\u7624\u57fa\u56e0\u9ad4\u8b8a\u7570\u3002 \u7f8e\u570b FDA \u7684\u6838\u51c6\u904e\u7a0b\u65e2\u7e41\u8907\u4ea6\u56b4\u683c\uff0c\u6db5\u84cb\u5206\u6790\u3001\u81e8\u5e8a\u53ca\u8cc7\u8a0a\u79d1\u6280\u7b49\u9818\u57df\u3002 \u00a0<\/p>\n<p>\u9019\u6b21\u6838\u51c6\u978f\u56fa\u4e86 DCG \u7684\u5730\u4f4d\uff0c\u4ee4\u516c\u53f8\u5f97\u4ee5\u5728\u81e8\u5e8a\u7ba1\u7406\u652f\u63f4\u3001\u8f49\u5316\u7814\u7a76\u8207\u751f\u7269\u6a19\u8a18\u958b\u767c\u7b49\u9818\u57df\uff0c\u8207\u570b\u969b\u81e8\u5e8a\u3001\u5b78\u8853\u53ca\u751f\u7269\u88fd\u85e5\u5925\u4f34\u65bc\u5171\u540c\u7684\u6cd5\u898f\u57fa\u790e\u4e0a\u5c55\u958b\u5408\u4f5c\u3002<\/p>\n<p>\u5168\u7403\u7b56\u7565\u8207\u696d\u52d9\u62d3\u5c55\u9ad8\u7d1a\u7e3d\u76e3 Vineet Datta \u535a\u58eb\u8868\u793a\uff1a<i>\u300cCell<sup>Dx<\/sup>-Tissue \u6aa2\u6e2c\u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u70ba DCG \u6240\u63d0\u4f9b\u7684\u91cd\u8981\u89e3\u6c7a\u65b9\u6848\u589e\u6dfb\u4e86\u300c\u9ec3\u91d1\u6a19\u6e96\u300d\u7d1a\u5225\u7684\u76e3\u7ba1\u8a8d\u53ef\u3002 Cell<sup>Dx<\/sup>-Tissue \u5f4c\u88dc\u4e86\u57fa\u56e0\u9ad4\u8907\u96dc\u6027\u8207\u81e8\u5e8a\u6c7a\u7b56\u4e4b\u9593\u7684\u7f3a\u53e3\uff0c\u5728\u6cbb\u7642\u65b9\u6cd5\u8fc5\u901f\u6f14\u8b8a\u7684\u6642\u4ee3\u4e2d\uff0c\u70ba\u60a3\u8005\u63d0\u4f9b\u4e86\u66f4\u5ee3\u6cdb\u7684\u9078\u64c7\u3002 \u80fd\u5c07\u9019\u9805\u6280\u8853\u5e36\u7d66\u5168\u7403\u7684\u816b\u7624\u79d1\u91ab\u751f\uff0c\u4ee4\u6211\u5011\u611f\u5230\u76f8\u7576\u81ea\u8c6a\u3002\u300d<\/i><\/p>\n<p>\u96c6\u5718\u91ab\u7642\u4e8b\u52d9\u9ad8\u7d1a\u7e3d\u76e3 Darshana Patil \u535a\u58eb\u5247\u8868\u793a\uff1a<i>\u300c\u6211\u5011\u4ee5\u7d44\u7e54\u70ba\u57fa\u790e\u7684\u57fa\u56e0\u9ad4\u6aa2\u6e2c\u65b9\u6848\u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u662f\u5c0d\u672c\u516c\u53f8\u79d1\u5b78\u6280\u8853\u548c\u54c1\u8cea\u7cfb\u7d71\u7684\u5be6\u8cea\u9a57\u8b49\u3002 \u6b64\u8209\u4ee4\u6211\u5011\u5f97\u4ee5\u70ba\u816b\u7624\u79d1\u91ab\u751f\u63d0\u4f9b\u53ef\u9760\u3001\u6a19\u6e96\u5316\u7684\u57fa\u56e0\u9ad4\u8cc7\u8a0a\uff0c\u70ba\u8907\u96dc\u7684\u6cbb\u7642\u6c7a\u7b56\u63d0\u4f9b\u6307\u5f15\uff0c\u4e26\u4e14\u978f\u56fa\u4e86\u6211\u5011\u7684\u627f\u8afe\uff0c\u5c31\u662f\u8981\u7d50\u5408\u5148\u9032\u57fa\u56e0\u9ad4\u6280\u8853\u3001\u56b4\u8b39\u79d1\u5b78\u65b9\u6cd5\u8207\u81e8\u5e8a\u5be6\u52d9\u50f9\u503c\u4f86\u670d\u52d9\u764c\u75c7\u75c5\u60a3\u8005\u3002\u300d<\/i><\/p>\n<p>\u7814\u767c\u8207\u5275\u65b0\u7e3d\u76e3 Dadasaheb Akolkar \u535a\u58eb\u88dc\u5145\u9053\uff1a<i>\u300c\u9019\u6b21\u7372\u5f97\u6838\u51c6\uff0c\u5145\u5206\u9ad4\u73fe\u4e86\u6211\u5011\u7684\u79d1\u5b78\u8207\u54c1\u8cea\u5718\u968a\u5728 Cell<sup>Dx<\/sup>-Tissue \u5e73\u53f0\u958b\u767c\u904e\u7a0b\u4e2d\u6240\u5c55\u73fe\u51fa\u7684\u4e00\u81f4\u6027\u3001\u56b4\u8b39\u6027\u53ca\u4ee5\u81e8\u5e8a\u70ba\u5c0e\u5411\u7684\u8a2d\u8a08\u7406\u5ff5\u3002 \u6211\u5011\u71b1\u5207\u671f\u5f85\u5c07\u9019\u9805\u8b8a\u9769\u6027\u7684\u7cbe\u6e96\u816b\u7624\u91ab\u5b78\u89e3\u6c7a\u65b9\u6848\u63a8\u5ee3\u81f3\u5168\u7403\u5e02\u5834\uff0c\u8b93\u66f4\u591a\u764c\u75c7\u75c5\u60a3\u8005\u53d7\u60e0\u3002\u300d<\/i><\/p>\n<p><b>\u95dc\u65bc Datar Cancer Genetics<\/b><\/p>\n<p>Datar Cancer Genetics (DCG) \u662f\u4e00\u9593\u5168\u7403\u6027\u3001\u7531\u4eba\u5de5\u667a\u80fd\u9a45\u52d5\u7684\u7cbe\u6e96\u816b\u7624\u91ab\u5b78\u516c\u53f8\uff0c\u5c08\u6ce8\u65bc\u958b\u767c\u53ca\u63d0\u4f9b\u5148\u9032\u7684\u764c\u75c7\u8a3a\u65b7\u6280\u8853\uff0c\u5305\u62ec\u7528\u65bc\u65e9\u671f\u6aa2\u6e2c\u3001\u6cbb\u7642\u9078\u64c7\u548c\u764c\u75c7\u76e3\u6e2c\u7684\u975e\u4fb5\u5165\u6027\u6db2\u614b\u5207\u7247\u53ca\u4ee5\u7d44\u7e54\u70ba\u57fa\u790e\u7684\u591a\u9ad4\u5b78\u89e3\u6c7a\u65b9\u6848\u3002 DCG \u64c1\u6709\u7372\u5f97 UKAS\u3001CAP \u53ca CLIA \u8a8d\u8b49\u7684\u5be6\u9a57\u5ba4\uff0c\u696d\u52d9\u8db3\u8de1\u904d\u53ca\u82f1\u570b\u3001\u6b50\u76df\u3001\u7f8e\u570b\u3001\u6d77\u7063\u5408\u4f5c\u59d4\u54e1\u6703\u570b\u5bb6\u548c\u4e9e\u6d32\u3002 DCG \u8207\u5168\u7403\u81e8\u5e8a\u91ab\u751f\u53ca\u764c\u75c7\u4e2d\u5fc3\u5408\u4f5c\uff0c\u70ba\u5be6\u9ad4\u5668\u5b98\u764c\u75c7\u60a3\u8005\u63d0\u4f9b\u500b\u4eba\u5c08\u5c6c\u7684\u764c\u75c7\u8b77\u7406\u3002<\/p>\n<p>\u7db2\u9801\uff1a<a href=\"https:\/\/datarpgx.com\/celldx-tissue\" target=\"_blank\" rel=\"nofollow\" style=\"color: #0000FF\">https:\/\/datarpgx.com\/celldx-tissue<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u662f\u6b21\u6838\u51c6\u8a8d\u5b9a\u4e86 CellDx-&#8230;<\/p>\n","protected":false},"author":16,"featured_media":436021,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"fifu_image_url":"","fifu_image_alt":"","footnotes":""},"categories":[40567],"tags":[],"class_list":["post-436020","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-40567"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Datar Cancer Genetics \u7684 CellDx-Tissue \u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u70ba\u8a72\u9805\u5229\u7528 DNA \u8207 RNA \u9032\u884c\u7684\u5be6\u9ad4\u816b\u7624\u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u6aa2\u6e2c\u5beb\u4e0b\u91cc\u7a0b\u7891 - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831<\/title>\n<meta name=\"description\" content=\"\u662f\u6b21\u6838\u51c6\u8a8d\u5b9a\u4e86 CellDx-Tissue \u7684 DNA \u8207 RNA \u96d9\u5206\u6790\u7269\u5de5\u4f5c\u6d41\u7a0b\uff0c\u6db5\u84cb 517 \u500b\u8207\u764c\u75c7\u76f8\u95dc\u7684\u57fa\u56e0\uff0c\u4e26\u80fd\u4ee5 RNA \u5c64\u7d1a\u8b49\u64da\u5075\u6e2c ALK\u3001RET \u8207 ROS1 \u7b49\u95dc\u9375\u878d\u5408\u57fa\u56e0 \u5370\u5ea6\u7d0d\u897f\u514b2026\u5e745\u670815\u65e5 \/\u7f8e\u901a\u793e\/ -- \u5168\u7403\u7cbe\u6e96\u816b\u7624\u91ab\u5b78\u516c\u53f8 Datar Cancer Genetics (DCG) \u4eca\u65e5\u5ba3\u4f48\uff0c\u5176\u9069\u7528\u65bc\u6240\u6709\u5be6\u9ad4\u816b\u7624\u3001\u4ee5\u7d44\u7e54\u70ba\u57fa\u790e\u7684\u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790 (comprehensive genomic profiling\uff0c\u7c21\u7a31 CGP) \u6aa2\u6e2c\u65b9\u6cd5 CellDx-Tissue\uff0c\u5df2\u7372\u5f97\u7f8e\u570b\u98df\u54c1\u53ca\u85e5\u7269\u7ba1\u7406\u5c40\uff08US Food and Drug Administration\uff0c\u7c21\u7a31\u7f8e\u570b FDA\uff09\u7684\u6838\u51c6\u3002      CellDx-Tissue- \u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u6aa2\u6e2c  \u662f\u6b21\u6838\u51c6\u9032\u4e00\u6b65\u978f\u56fa DCG \u5728\u63d0\u4f9b\u7a81\u7834\u6027\u5e73\u53f0\u65b9\u9762\u7684\u5730\u4f4d\uff0c\u8a72\u5e73\u53f0\u65e8\u5728\u5354\u52a9\u5168\u7403\u816b\u7624\u79d1\u91ab\u751f\u6839\u64da\u5c08\u696d\u6307\u5f15\u4f5c\u51fa\u500b\u4eba\u5c08\u5c6c\u7684\u81e8\u5e8a\u7ba1\u7406\u6c7a\u7b56\uff0c\u4e26\u4e14\u8207\u8a72\u516c\u53f8\u65e9\u524d\u91dd\u5c0d\u5176\u6db2\u614b\u5207\u7247\u5e73\u53f0\u800c\u7372\u5f97\u7684\u7f8e\u570b FDA \u7a81\u7834\u6027\u91ab\u7642\u5668\u6750\u8a8d\u5b9a (US FDA Breakthrough Device Designations) \u4e92\u76f8\u88dc\u8db3\u3002 \u95dc\u65bc CellDx-Tissue CellDx-Tissue \u662f\u4e00\u7a2e\u5b9a\u6027\u9ad4\u5916\u8a3a\u65b7 (IVD) \u6aa2\u6e2c\uff0c\u5b83\u5229\u7528\u6a19\u9776\u5f0f\u6b21\u4e16\u4ee3\u5b9a\u5e8f (NGS) \u6280\u8853\uff0c\u5c0d\u5f9e\u798f\u723e\u99ac\u6797\u56fa\u5b9a\u77f3\u881f\u5305\u57cb (FFPE) \u5be6\u9ad4\u816b\u7624\u60a3\u8005\u7684\u816b\u7624\u7d44\u7e54\u4e2d\u5206\u96e2\u7684 DNA \u53ca RNA \u9032\u884c\u5206\u6790\u3002 \u6b64\u6aa2\u6e2c\u5206\u6790 517 \u500b\u8207\u764c\u75c7\u76f8\u95dc\u7684\u57fa\u56e0\uff0c\u76ee\u7684\u5728\u65bc\u63d0\u4f9b\u6709\u95dc\u9ad4\u7d30\u80de\u55ae\u6838\u82f7\u9178\u8b8a\u7570 (SNV)\u3001\u5c0f\u7247\u6bb5\u63d2\u5165\u548c\u7f3a\u5931 (InDels)\u3001ERBB2 \u57fa\u56e0\u64f4\u589e\u8207\u6d89\u53ca ALK\u3001RET \u548c ROS1 \u7684\u57fa\u56e0\u878d\u5408\u8cc7\u8a0a\u3002 CellDx-Tissue \u70ba\u55ae\u4e00\u5be6\u9a57\u5ba4\u6aa2\u6e2c\uff0c\u7531 Datar Cancer Genetics \u65d7\u4e0b\u7372\u5f97 CAP \u53ca CLIA \u8a8d\u8b49\u7684\u5be6\u9a57\u5ba4\u9032\u884c\u3002 \u91cd\u8981\u610f\u7fa9 \u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u5df2\u6210\u70ba\u5be6\u9ad4\u816b\u7624\u81e8\u5e8a\u7ba1\u7406\u7684\u6838\u5fc3\u7d44\u6210\u90e8\u5206\uff0c\u5354\u52a9\u81e8\u5e8a\u91ab\u751f\u5728\u591a\u7a2e\u764c\u75c7\u985e\u578b\u4e2d\u5168\u9762\u89e3\u6790\u816b\u7624\u57fa\u56e0\u9ad4\u8b8a\u7570\u3002 \u7f8e\u570b FDA \u7684\u6838\u51c6\u904e\u7a0b\u65e2\u7e41\u8907\u4ea6\u56b4\u683c\uff0c\u6db5\u84cb\u5206\u6790\u3001\u81e8\u5e8a\u53ca\u8cc7\u8a0a\u79d1\u6280\u7b49\u9818\u57df\u3002 \u00a0 \u9019\u6b21\u6838\u51c6\u978f\u56fa\u4e86 DCG \u7684\u5730\u4f4d\uff0c\u4ee4\u516c\u53f8\u5f97\u4ee5\u5728\u81e8\u5e8a\u7ba1\u7406\u652f\u63f4\u3001\u8f49\u5316\u7814\u7a76\u8207\u751f\u7269\u6a19\u8a18\u958b\u767c\u7b49\u9818\u57df\uff0c\u8207\u570b\u969b\u81e8\u5e8a\u3001\u5b78\u8853\u53ca\u751f\u7269\u88fd\u85e5\u5925\u4f34\u65bc\u5171\u540c\u7684\u6cd5\u898f\u57fa\u790e\u4e0a\u5c55\u958b\u5408\u4f5c\u3002 \u5168\u7403\u7b56\u7565\u8207\u696d\u52d9\u62d3\u5c55\u9ad8\u7d1a\u7e3d\u76e3 Vineet Datta \u535a\u58eb\u8868\u793a\uff1a\u300cCellDx-Tissue \u6aa2\u6e2c\u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u70ba DCG \u6240\u63d0\u4f9b\u7684\u91cd\u8981\u89e3\u6c7a\u65b9\u6848\u589e\u6dfb\u4e86\u300c\u9ec3\u91d1\u6a19\u6e96\u300d\u7d1a\u5225\u7684\u76e3\u7ba1\u8a8d\u53ef\u3002 CellDx-Tissue \u5f4c\u88dc\u4e86\u57fa\u56e0\u9ad4\u8907\u96dc\u6027\u8207\u81e8\u5e8a\u6c7a\u7b56\u4e4b\u9593\u7684\u7f3a\u53e3\uff0c\u5728\u6cbb\u7642\u65b9\u6cd5\u8fc5\u901f\u6f14\u8b8a\u7684\u6642\u4ee3\u4e2d\uff0c\u70ba\u60a3\u8005\u63d0\u4f9b\u4e86\u66f4\u5ee3\u6cdb\u7684\u9078\u64c7\u3002 \u80fd\u5c07\u9019\u9805\u6280\u8853\u5e36\u7d66\u5168\u7403\u7684\u816b\u7624\u79d1\u91ab\u751f\uff0c\u4ee4\u6211\u5011\u611f\u5230\u76f8\u7576\u81ea\u8c6a\u3002\u300d \u96c6\u5718\u91ab\u7642\u4e8b\u52d9\u9ad8\u7d1a\u7e3d\u76e3 Darshana Patil \u535a\u58eb\u5247\u8868\u793a\uff1a\u300c\u6211\u5011\u4ee5\u7d44\u7e54\u70ba\u57fa\u790e\u7684\u57fa\u56e0\u9ad4\u6aa2\u6e2c\u65b9\u6848\u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u662f\u5c0d\u672c\u516c\u53f8\u79d1\u5b78\u6280\u8853\u548c\u54c1\u8cea\u7cfb\u7d71\u7684\u5be6\u8cea\u9a57\u8b49\u3002 \u6b64\u8209\u4ee4\u6211\u5011\u5f97\u4ee5\u70ba\u816b\u7624\u79d1\u91ab\u751f\u63d0\u4f9b\u53ef\u9760\u3001\u6a19\u6e96\u5316\u7684\u57fa\u56e0\u9ad4\u8cc7\u8a0a\uff0c\u70ba\u8907\u96dc\u7684\u6cbb\u7642\u6c7a\u7b56\u63d0\u4f9b\u6307\u5f15\uff0c\u4e26\u4e14\u978f\u56fa\u4e86\u6211\u5011\u7684\u627f\u8afe\uff0c\u5c31\u662f\u8981\u7d50\u5408\u5148\u9032\u57fa\u56e0\u9ad4\u6280\u8853\u3001\u56b4\u8b39\u79d1\u5b78\u65b9\u6cd5\u8207\u81e8\u5e8a\u5be6\u52d9\u50f9\u503c\u4f86\u670d\u52d9\u764c\u75c7\u75c5\u60a3\u8005\u3002\u300d \u7814\u767c\u8207\u5275\u65b0\u7e3d\u76e3 Dadasaheb Akolkar \u535a\u58eb\u88dc\u5145\u9053\uff1a\u300c\u9019\u6b21\u7372\u5f97\u6838\u51c6\uff0c\u5145\u5206\u9ad4\u73fe\u4e86\u6211\u5011\u7684\u79d1\u5b78\u8207\u54c1\u8cea\u5718\u968a\u5728 CellDx-Tissue \u5e73\u53f0\u958b\u767c\u904e\u7a0b\u4e2d\u6240\u5c55\u73fe\u51fa\u7684\u4e00\u81f4\u6027\u3001\u56b4\u8b39\u6027\u53ca\u4ee5\u81e8\u5e8a\u70ba\u5c0e\u5411\u7684\u8a2d\u8a08\u7406\u5ff5\u3002 \u6211\u5011\u71b1\u5207\u671f\u5f85\u5c07\u9019\u9805\u8b8a\u9769\u6027\u7684\u7cbe\u6e96\u816b\u7624\u91ab\u5b78\u89e3\u6c7a\u65b9\u6848\u63a8\u5ee3\u81f3\u5168\u7403\u5e02\u5834\uff0c\u8b93\u66f4\u591a\u764c\u75c7\u75c5\u60a3\u8005\u53d7\u60e0\u3002\u300d \u95dc\u65bc Datar Cancer Genetics Datar Cancer Genetics (DCG) \u662f\u4e00\u9593\u5168\u7403\u6027\u3001\u7531\u4eba\u5de5\u667a\u80fd\u9a45\u52d5\u7684\u7cbe\u6e96\u816b\u7624\u91ab\u5b78\u516c\u53f8\uff0c\u5c08\u6ce8\u65bc\u958b\u767c\u53ca\u63d0\u4f9b\u5148\u9032\u7684\u764c\u75c7\u8a3a\u65b7\u6280\u8853\uff0c\u5305\u62ec\u7528\u65bc\u65e9\u671f\u6aa2\u6e2c\u3001\u6cbb\u7642\u9078\u64c7\u548c\u764c\u75c7\u76e3\u6e2c\u7684\u975e\u4fb5\u5165\u6027\u6db2\u614b\u5207\u7247\u53ca\u4ee5\u7d44\u7e54\u70ba\u57fa\u790e\u7684\u591a\u9ad4\u5b78\u89e3\u6c7a\u65b9\u6848\u3002 DCG \u64c1\u6709\u7372\u5f97 UKAS\u3001CAP \u53ca CLIA \u8a8d\u8b49\u7684\u5be6\u9a57\u5ba4\uff0c\u696d\u52d9\u8db3\u8de1\u904d\u53ca\u82f1\u570b\u3001\u6b50\u76df\u3001\u7f8e\u570b\u3001\u6d77\u7063\u5408\u4f5c\u59d4\u54e1\u6703\u570b\u5bb6\u548c\u4e9e\u6d32\u3002 DCG \u8207\u5168\u7403\u81e8\u5e8a\u91ab\u751f\u53ca\u764c\u75c7\u4e2d\u5fc3\u5408\u4f5c\uff0c\u70ba\u5be6\u9ad4\u5668\u5b98\u764c\u75c7\u60a3\u8005\u63d0\u4f9b\u500b\u4eba\u5c08\u5c6c\u7684\u764c\u75c7\u8b77\u7406\u3002 \u7db2\u9801\uff1ahttps:\/\/datarpgx.com\/celldx-tissue\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pingtungtimes.com.tw\/?p=436020\" \/>\n<meta property=\"og:locale\" content=\"zh_TW\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Datar Cancer Genetics \u7684 CellDx-Tissue \u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u70ba\u8a72\u9805\u5229\u7528 DNA \u8207 RNA \u9032\u884c\u7684\u5be6\u9ad4\u816b\u7624\u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u6aa2\u6e2c\u5beb\u4e0b\u91cc\u7a0b\u7891 - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\" \/>\n<meta property=\"og:description\" content=\"\u662f\u6b21\u6838\u51c6\u8a8d\u5b9a\u4e86 CellDx-Tissue \u7684 DNA \u8207 RNA \u96d9\u5206\u6790\u7269\u5de5\u4f5c\u6d41\u7a0b\uff0c\u6db5\u84cb 517 \u500b\u8207\u764c\u75c7\u76f8\u95dc\u7684\u57fa\u56e0\uff0c\u4e26\u80fd\u4ee5 RNA \u5c64\u7d1a\u8b49\u64da\u5075\u6e2c ALK\u3001RET \u8207 ROS1 \u7b49\u95dc\u9375\u878d\u5408\u57fa\u56e0 \u5370\u5ea6\u7d0d\u897f\u514b2026\u5e745\u670815\u65e5 \/\u7f8e\u901a\u793e\/ -- \u5168\u7403\u7cbe\u6e96\u816b\u7624\u91ab\u5b78\u516c\u53f8 Datar Cancer Genetics (DCG) \u4eca\u65e5\u5ba3\u4f48\uff0c\u5176\u9069\u7528\u65bc\u6240\u6709\u5be6\u9ad4\u816b\u7624\u3001\u4ee5\u7d44\u7e54\u70ba\u57fa\u790e\u7684\u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790 (comprehensive genomic profiling\uff0c\u7c21\u7a31 CGP) \u6aa2\u6e2c\u65b9\u6cd5 CellDx-Tissue\uff0c\u5df2\u7372\u5f97\u7f8e\u570b\u98df\u54c1\u53ca\u85e5\u7269\u7ba1\u7406\u5c40\uff08US Food and Drug Administration\uff0c\u7c21\u7a31\u7f8e\u570b FDA\uff09\u7684\u6838\u51c6\u3002      CellDx-Tissue- \u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u6aa2\u6e2c  \u662f\u6b21\u6838\u51c6\u9032\u4e00\u6b65\u978f\u56fa DCG \u5728\u63d0\u4f9b\u7a81\u7834\u6027\u5e73\u53f0\u65b9\u9762\u7684\u5730\u4f4d\uff0c\u8a72\u5e73\u53f0\u65e8\u5728\u5354\u52a9\u5168\u7403\u816b\u7624\u79d1\u91ab\u751f\u6839\u64da\u5c08\u696d\u6307\u5f15\u4f5c\u51fa\u500b\u4eba\u5c08\u5c6c\u7684\u81e8\u5e8a\u7ba1\u7406\u6c7a\u7b56\uff0c\u4e26\u4e14\u8207\u8a72\u516c\u53f8\u65e9\u524d\u91dd\u5c0d\u5176\u6db2\u614b\u5207\u7247\u5e73\u53f0\u800c\u7372\u5f97\u7684\u7f8e\u570b FDA \u7a81\u7834\u6027\u91ab\u7642\u5668\u6750\u8a8d\u5b9a (US FDA Breakthrough Device Designations) \u4e92\u76f8\u88dc\u8db3\u3002 \u95dc\u65bc CellDx-Tissue CellDx-Tissue \u662f\u4e00\u7a2e\u5b9a\u6027\u9ad4\u5916\u8a3a\u65b7 (IVD) \u6aa2\u6e2c\uff0c\u5b83\u5229\u7528\u6a19\u9776\u5f0f\u6b21\u4e16\u4ee3\u5b9a\u5e8f (NGS) \u6280\u8853\uff0c\u5c0d\u5f9e\u798f\u723e\u99ac\u6797\u56fa\u5b9a\u77f3\u881f\u5305\u57cb (FFPE) \u5be6\u9ad4\u816b\u7624\u60a3\u8005\u7684\u816b\u7624\u7d44\u7e54\u4e2d\u5206\u96e2\u7684 DNA \u53ca RNA \u9032\u884c\u5206\u6790\u3002 \u6b64\u6aa2\u6e2c\u5206\u6790 517 \u500b\u8207\u764c\u75c7\u76f8\u95dc\u7684\u57fa\u56e0\uff0c\u76ee\u7684\u5728\u65bc\u63d0\u4f9b\u6709\u95dc\u9ad4\u7d30\u80de\u55ae\u6838\u82f7\u9178\u8b8a\u7570 (SNV)\u3001\u5c0f\u7247\u6bb5\u63d2\u5165\u548c\u7f3a\u5931 (InDels)\u3001ERBB2 \u57fa\u56e0\u64f4\u589e\u8207\u6d89\u53ca ALK\u3001RET \u548c ROS1 \u7684\u57fa\u56e0\u878d\u5408\u8cc7\u8a0a\u3002 CellDx-Tissue \u70ba\u55ae\u4e00\u5be6\u9a57\u5ba4\u6aa2\u6e2c\uff0c\u7531 Datar Cancer Genetics \u65d7\u4e0b\u7372\u5f97 CAP \u53ca CLIA \u8a8d\u8b49\u7684\u5be6\u9a57\u5ba4\u9032\u884c\u3002 \u91cd\u8981\u610f\u7fa9 \u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u5df2\u6210\u70ba\u5be6\u9ad4\u816b\u7624\u81e8\u5e8a\u7ba1\u7406\u7684\u6838\u5fc3\u7d44\u6210\u90e8\u5206\uff0c\u5354\u52a9\u81e8\u5e8a\u91ab\u751f\u5728\u591a\u7a2e\u764c\u75c7\u985e\u578b\u4e2d\u5168\u9762\u89e3\u6790\u816b\u7624\u57fa\u56e0\u9ad4\u8b8a\u7570\u3002 \u7f8e\u570b FDA \u7684\u6838\u51c6\u904e\u7a0b\u65e2\u7e41\u8907\u4ea6\u56b4\u683c\uff0c\u6db5\u84cb\u5206\u6790\u3001\u81e8\u5e8a\u53ca\u8cc7\u8a0a\u79d1\u6280\u7b49\u9818\u57df\u3002 \u00a0 \u9019\u6b21\u6838\u51c6\u978f\u56fa\u4e86 DCG \u7684\u5730\u4f4d\uff0c\u4ee4\u516c\u53f8\u5f97\u4ee5\u5728\u81e8\u5e8a\u7ba1\u7406\u652f\u63f4\u3001\u8f49\u5316\u7814\u7a76\u8207\u751f\u7269\u6a19\u8a18\u958b\u767c\u7b49\u9818\u57df\uff0c\u8207\u570b\u969b\u81e8\u5e8a\u3001\u5b78\u8853\u53ca\u751f\u7269\u88fd\u85e5\u5925\u4f34\u65bc\u5171\u540c\u7684\u6cd5\u898f\u57fa\u790e\u4e0a\u5c55\u958b\u5408\u4f5c\u3002 \u5168\u7403\u7b56\u7565\u8207\u696d\u52d9\u62d3\u5c55\u9ad8\u7d1a\u7e3d\u76e3 Vineet Datta \u535a\u58eb\u8868\u793a\uff1a\u300cCellDx-Tissue \u6aa2\u6e2c\u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u70ba DCG \u6240\u63d0\u4f9b\u7684\u91cd\u8981\u89e3\u6c7a\u65b9\u6848\u589e\u6dfb\u4e86\u300c\u9ec3\u91d1\u6a19\u6e96\u300d\u7d1a\u5225\u7684\u76e3\u7ba1\u8a8d\u53ef\u3002 CellDx-Tissue \u5f4c\u88dc\u4e86\u57fa\u56e0\u9ad4\u8907\u96dc\u6027\u8207\u81e8\u5e8a\u6c7a\u7b56\u4e4b\u9593\u7684\u7f3a\u53e3\uff0c\u5728\u6cbb\u7642\u65b9\u6cd5\u8fc5\u901f\u6f14\u8b8a\u7684\u6642\u4ee3\u4e2d\uff0c\u70ba\u60a3\u8005\u63d0\u4f9b\u4e86\u66f4\u5ee3\u6cdb\u7684\u9078\u64c7\u3002 \u80fd\u5c07\u9019\u9805\u6280\u8853\u5e36\u7d66\u5168\u7403\u7684\u816b\u7624\u79d1\u91ab\u751f\uff0c\u4ee4\u6211\u5011\u611f\u5230\u76f8\u7576\u81ea\u8c6a\u3002\u300d \u96c6\u5718\u91ab\u7642\u4e8b\u52d9\u9ad8\u7d1a\u7e3d\u76e3 Darshana Patil \u535a\u58eb\u5247\u8868\u793a\uff1a\u300c\u6211\u5011\u4ee5\u7d44\u7e54\u70ba\u57fa\u790e\u7684\u57fa\u56e0\u9ad4\u6aa2\u6e2c\u65b9\u6848\u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u662f\u5c0d\u672c\u516c\u53f8\u79d1\u5b78\u6280\u8853\u548c\u54c1\u8cea\u7cfb\u7d71\u7684\u5be6\u8cea\u9a57\u8b49\u3002 \u6b64\u8209\u4ee4\u6211\u5011\u5f97\u4ee5\u70ba\u816b\u7624\u79d1\u91ab\u751f\u63d0\u4f9b\u53ef\u9760\u3001\u6a19\u6e96\u5316\u7684\u57fa\u56e0\u9ad4\u8cc7\u8a0a\uff0c\u70ba\u8907\u96dc\u7684\u6cbb\u7642\u6c7a\u7b56\u63d0\u4f9b\u6307\u5f15\uff0c\u4e26\u4e14\u978f\u56fa\u4e86\u6211\u5011\u7684\u627f\u8afe\uff0c\u5c31\u662f\u8981\u7d50\u5408\u5148\u9032\u57fa\u56e0\u9ad4\u6280\u8853\u3001\u56b4\u8b39\u79d1\u5b78\u65b9\u6cd5\u8207\u81e8\u5e8a\u5be6\u52d9\u50f9\u503c\u4f86\u670d\u52d9\u764c\u75c7\u75c5\u60a3\u8005\u3002\u300d \u7814\u767c\u8207\u5275\u65b0\u7e3d\u76e3 Dadasaheb Akolkar \u535a\u58eb\u88dc\u5145\u9053\uff1a\u300c\u9019\u6b21\u7372\u5f97\u6838\u51c6\uff0c\u5145\u5206\u9ad4\u73fe\u4e86\u6211\u5011\u7684\u79d1\u5b78\u8207\u54c1\u8cea\u5718\u968a\u5728 CellDx-Tissue \u5e73\u53f0\u958b\u767c\u904e\u7a0b\u4e2d\u6240\u5c55\u73fe\u51fa\u7684\u4e00\u81f4\u6027\u3001\u56b4\u8b39\u6027\u53ca\u4ee5\u81e8\u5e8a\u70ba\u5c0e\u5411\u7684\u8a2d\u8a08\u7406\u5ff5\u3002 \u6211\u5011\u71b1\u5207\u671f\u5f85\u5c07\u9019\u9805\u8b8a\u9769\u6027\u7684\u7cbe\u6e96\u816b\u7624\u91ab\u5b78\u89e3\u6c7a\u65b9\u6848\u63a8\u5ee3\u81f3\u5168\u7403\u5e02\u5834\uff0c\u8b93\u66f4\u591a\u764c\u75c7\u75c5\u60a3\u8005\u53d7\u60e0\u3002\u300d \u95dc\u65bc Datar Cancer Genetics Datar Cancer Genetics (DCG) \u662f\u4e00\u9593\u5168\u7403\u6027\u3001\u7531\u4eba\u5de5\u667a\u80fd\u9a45\u52d5\u7684\u7cbe\u6e96\u816b\u7624\u91ab\u5b78\u516c\u53f8\uff0c\u5c08\u6ce8\u65bc\u958b\u767c\u53ca\u63d0\u4f9b\u5148\u9032\u7684\u764c\u75c7\u8a3a\u65b7\u6280\u8853\uff0c\u5305\u62ec\u7528\u65bc\u65e9\u671f\u6aa2\u6e2c\u3001\u6cbb\u7642\u9078\u64c7\u548c\u764c\u75c7\u76e3\u6e2c\u7684\u975e\u4fb5\u5165\u6027\u6db2\u614b\u5207\u7247\u53ca\u4ee5\u7d44\u7e54\u70ba\u57fa\u790e\u7684\u591a\u9ad4\u5b78\u89e3\u6c7a\u65b9\u6848\u3002 DCG \u64c1\u6709\u7372\u5f97 UKAS\u3001CAP \u53ca CLIA \u8a8d\u8b49\u7684\u5be6\u9a57\u5ba4\uff0c\u696d\u52d9\u8db3\u8de1\u904d\u53ca\u82f1\u570b\u3001\u6b50\u76df\u3001\u7f8e\u570b\u3001\u6d77\u7063\u5408\u4f5c\u59d4\u54e1\u6703\u570b\u5bb6\u548c\u4e9e\u6d32\u3002 DCG \u8207\u5168\u7403\u81e8\u5e8a\u91ab\u751f\u53ca\u764c\u75c7\u4e2d\u5fc3\u5408\u4f5c\uff0c\u70ba\u5be6\u9ad4\u5668\u5b98\u764c\u75c7\u60a3\u8005\u63d0\u4f9b\u500b\u4eba\u5c08\u5c6c\u7684\u764c\u75c7\u8b77\u7406\u3002 \u7db2\u9801\uff1ahttps:\/\/datarpgx.com\/celldx-tissue\" \/>\n<meta property=\"og:url\" content=\"https:\/\/pingtungtimes.com.tw\/?p=436020\" \/>\n<meta property=\"og:site_name\" content=\"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/pingtungnews\" \/>\n<meta property=\"article:published_time\" content=\"2026-05-15T14:00:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2023\/02\/logo-150.png\" \/>\n\t<meta property=\"og:image:width\" content=\"3000\" \/>\n\t<meta property=\"og:image:height\" content=\"1990\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"\u7f8e\u901a\u793e\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u4f5c\u8005:\" \/>\n\t<meta name=\"twitter:data1\" content=\"\u7f8e\u901a\u793e\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"NewsArticle\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=436020#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=436020\"},\"author\":{\"name\":\"\u7f8e\u901a\u793e\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#\\\/schema\\\/person\\\/683b937f29ec1537972f6c41e22a2cf3\"},\"headline\":\"Datar Cancer Genetics \u7684 CellDx-Tissue \u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u70ba\u8a72\u9805\u5229\u7528 DNA \u8207 RNA \u9032\u884c\u7684\u5be6\u9ad4\u816b\u7624\u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u6aa2\u6e2c\u5beb\u4e0b\u91cc\u7a0b\u7891\",\"datePublished\":\"2026-05-15T14:00:00+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=436020\"},\"wordCount\":87,\"publisher\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=436020#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/wp-content\\\/uploads\\\/2026\\\/05\\\/Datar_Cancer_Genetics_US_FDA.jpg\",\"articleSection\":[\"\u7f8e\u901a\u793e\"],\"inLanguage\":\"zh-TW\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=436020\",\"url\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=436020\",\"name\":\"Datar Cancer Genetics \u7684 CellDx-Tissue \u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u70ba\u8a72\u9805\u5229\u7528 DNA \u8207 RNA \u9032\u884c\u7684\u5be6\u9ad4\u816b\u7624\u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u6aa2\u6e2c\u5beb\u4e0b\u91cc\u7a0b\u7891 - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=436020#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=436020#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/wp-content\\\/uploads\\\/2026\\\/05\\\/Datar_Cancer_Genetics_US_FDA.jpg\",\"datePublished\":\"2026-05-15T14:00:00+00:00\",\"description\":\"\u662f\u6b21\u6838\u51c6\u8a8d\u5b9a\u4e86 CellDx-Tissue \u7684 DNA \u8207 RNA \u96d9\u5206\u6790\u7269\u5de5\u4f5c\u6d41\u7a0b\uff0c\u6db5\u84cb 517 \u500b\u8207\u764c\u75c7\u76f8\u95dc\u7684\u57fa\u56e0\uff0c\u4e26\u80fd\u4ee5 RNA \u5c64\u7d1a\u8b49\u64da\u5075\u6e2c ALK\u3001RET \u8207 ROS1 \u7b49\u95dc\u9375\u878d\u5408\u57fa\u56e0 \u5370\u5ea6\u7d0d\u897f\u514b2026\u5e745\u670815\u65e5 \\\/\u7f8e\u901a\u793e\\\/ -- \u5168\u7403\u7cbe\u6e96\u816b\u7624\u91ab\u5b78\u516c\u53f8 Datar Cancer Genetics (DCG) \u4eca\u65e5\u5ba3\u4f48\uff0c\u5176\u9069\u7528\u65bc\u6240\u6709\u5be6\u9ad4\u816b\u7624\u3001\u4ee5\u7d44\u7e54\u70ba\u57fa\u790e\u7684\u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790 (comprehensive genomic profiling\uff0c\u7c21\u7a31 CGP) \u6aa2\u6e2c\u65b9\u6cd5 CellDx-Tissue\uff0c\u5df2\u7372\u5f97\u7f8e\u570b\u98df\u54c1\u53ca\u85e5\u7269\u7ba1\u7406\u5c40\uff08US Food and Drug Administration\uff0c\u7c21\u7a31\u7f8e\u570b FDA\uff09\u7684\u6838\u51c6\u3002 CellDx-Tissue- \u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u6aa2\u6e2c \u662f\u6b21\u6838\u51c6\u9032\u4e00\u6b65\u978f\u56fa DCG \u5728\u63d0\u4f9b\u7a81\u7834\u6027\u5e73\u53f0\u65b9\u9762\u7684\u5730\u4f4d\uff0c\u8a72\u5e73\u53f0\u65e8\u5728\u5354\u52a9\u5168\u7403\u816b\u7624\u79d1\u91ab\u751f\u6839\u64da\u5c08\u696d\u6307\u5f15\u4f5c\u51fa\u500b\u4eba\u5c08\u5c6c\u7684\u81e8\u5e8a\u7ba1\u7406\u6c7a\u7b56\uff0c\u4e26\u4e14\u8207\u8a72\u516c\u53f8\u65e9\u524d\u91dd\u5c0d\u5176\u6db2\u614b\u5207\u7247\u5e73\u53f0\u800c\u7372\u5f97\u7684\u7f8e\u570b FDA \u7a81\u7834\u6027\u91ab\u7642\u5668\u6750\u8a8d\u5b9a (US FDA Breakthrough Device Designations) \u4e92\u76f8\u88dc\u8db3\u3002 \u95dc\u65bc CellDx-Tissue CellDx-Tissue \u662f\u4e00\u7a2e\u5b9a\u6027\u9ad4\u5916\u8a3a\u65b7 (IVD) \u6aa2\u6e2c\uff0c\u5b83\u5229\u7528\u6a19\u9776\u5f0f\u6b21\u4e16\u4ee3\u5b9a\u5e8f (NGS) \u6280\u8853\uff0c\u5c0d\u5f9e\u798f\u723e\u99ac\u6797\u56fa\u5b9a\u77f3\u881f\u5305\u57cb (FFPE) \u5be6\u9ad4\u816b\u7624\u60a3\u8005\u7684\u816b\u7624\u7d44\u7e54\u4e2d\u5206\u96e2\u7684 DNA \u53ca RNA \u9032\u884c\u5206\u6790\u3002 \u6b64\u6aa2\u6e2c\u5206\u6790 517 \u500b\u8207\u764c\u75c7\u76f8\u95dc\u7684\u57fa\u56e0\uff0c\u76ee\u7684\u5728\u65bc\u63d0\u4f9b\u6709\u95dc\u9ad4\u7d30\u80de\u55ae\u6838\u82f7\u9178\u8b8a\u7570 (SNV)\u3001\u5c0f\u7247\u6bb5\u63d2\u5165\u548c\u7f3a\u5931 (InDels)\u3001ERBB2 \u57fa\u56e0\u64f4\u589e\u8207\u6d89\u53ca ALK\u3001RET \u548c ROS1 \u7684\u57fa\u56e0\u878d\u5408\u8cc7\u8a0a\u3002 CellDx-Tissue \u70ba\u55ae\u4e00\u5be6\u9a57\u5ba4\u6aa2\u6e2c\uff0c\u7531 Datar Cancer Genetics \u65d7\u4e0b\u7372\u5f97 CAP \u53ca CLIA \u8a8d\u8b49\u7684\u5be6\u9a57\u5ba4\u9032\u884c\u3002 \u91cd\u8981\u610f\u7fa9 \u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u5df2\u6210\u70ba\u5be6\u9ad4\u816b\u7624\u81e8\u5e8a\u7ba1\u7406\u7684\u6838\u5fc3\u7d44\u6210\u90e8\u5206\uff0c\u5354\u52a9\u81e8\u5e8a\u91ab\u751f\u5728\u591a\u7a2e\u764c\u75c7\u985e\u578b\u4e2d\u5168\u9762\u89e3\u6790\u816b\u7624\u57fa\u56e0\u9ad4\u8b8a\u7570\u3002 \u7f8e\u570b FDA \u7684\u6838\u51c6\u904e\u7a0b\u65e2\u7e41\u8907\u4ea6\u56b4\u683c\uff0c\u6db5\u84cb\u5206\u6790\u3001\u81e8\u5e8a\u53ca\u8cc7\u8a0a\u79d1\u6280\u7b49\u9818\u57df\u3002 \u00a0 \u9019\u6b21\u6838\u51c6\u978f\u56fa\u4e86 DCG \u7684\u5730\u4f4d\uff0c\u4ee4\u516c\u53f8\u5f97\u4ee5\u5728\u81e8\u5e8a\u7ba1\u7406\u652f\u63f4\u3001\u8f49\u5316\u7814\u7a76\u8207\u751f\u7269\u6a19\u8a18\u958b\u767c\u7b49\u9818\u57df\uff0c\u8207\u570b\u969b\u81e8\u5e8a\u3001\u5b78\u8853\u53ca\u751f\u7269\u88fd\u85e5\u5925\u4f34\u65bc\u5171\u540c\u7684\u6cd5\u898f\u57fa\u790e\u4e0a\u5c55\u958b\u5408\u4f5c\u3002 \u5168\u7403\u7b56\u7565\u8207\u696d\u52d9\u62d3\u5c55\u9ad8\u7d1a\u7e3d\u76e3 Vineet Datta \u535a\u58eb\u8868\u793a\uff1a\u300cCellDx-Tissue \u6aa2\u6e2c\u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u70ba DCG \u6240\u63d0\u4f9b\u7684\u91cd\u8981\u89e3\u6c7a\u65b9\u6848\u589e\u6dfb\u4e86\u300c\u9ec3\u91d1\u6a19\u6e96\u300d\u7d1a\u5225\u7684\u76e3\u7ba1\u8a8d\u53ef\u3002 CellDx-Tissue \u5f4c\u88dc\u4e86\u57fa\u56e0\u9ad4\u8907\u96dc\u6027\u8207\u81e8\u5e8a\u6c7a\u7b56\u4e4b\u9593\u7684\u7f3a\u53e3\uff0c\u5728\u6cbb\u7642\u65b9\u6cd5\u8fc5\u901f\u6f14\u8b8a\u7684\u6642\u4ee3\u4e2d\uff0c\u70ba\u60a3\u8005\u63d0\u4f9b\u4e86\u66f4\u5ee3\u6cdb\u7684\u9078\u64c7\u3002 \u80fd\u5c07\u9019\u9805\u6280\u8853\u5e36\u7d66\u5168\u7403\u7684\u816b\u7624\u79d1\u91ab\u751f\uff0c\u4ee4\u6211\u5011\u611f\u5230\u76f8\u7576\u81ea\u8c6a\u3002\u300d \u96c6\u5718\u91ab\u7642\u4e8b\u52d9\u9ad8\u7d1a\u7e3d\u76e3 Darshana Patil \u535a\u58eb\u5247\u8868\u793a\uff1a\u300c\u6211\u5011\u4ee5\u7d44\u7e54\u70ba\u57fa\u790e\u7684\u57fa\u56e0\u9ad4\u6aa2\u6e2c\u65b9\u6848\u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u662f\u5c0d\u672c\u516c\u53f8\u79d1\u5b78\u6280\u8853\u548c\u54c1\u8cea\u7cfb\u7d71\u7684\u5be6\u8cea\u9a57\u8b49\u3002 \u6b64\u8209\u4ee4\u6211\u5011\u5f97\u4ee5\u70ba\u816b\u7624\u79d1\u91ab\u751f\u63d0\u4f9b\u53ef\u9760\u3001\u6a19\u6e96\u5316\u7684\u57fa\u56e0\u9ad4\u8cc7\u8a0a\uff0c\u70ba\u8907\u96dc\u7684\u6cbb\u7642\u6c7a\u7b56\u63d0\u4f9b\u6307\u5f15\uff0c\u4e26\u4e14\u978f\u56fa\u4e86\u6211\u5011\u7684\u627f\u8afe\uff0c\u5c31\u662f\u8981\u7d50\u5408\u5148\u9032\u57fa\u56e0\u9ad4\u6280\u8853\u3001\u56b4\u8b39\u79d1\u5b78\u65b9\u6cd5\u8207\u81e8\u5e8a\u5be6\u52d9\u50f9\u503c\u4f86\u670d\u52d9\u764c\u75c7\u75c5\u60a3\u8005\u3002\u300d \u7814\u767c\u8207\u5275\u65b0\u7e3d\u76e3 Dadasaheb Akolkar \u535a\u58eb\u88dc\u5145\u9053\uff1a\u300c\u9019\u6b21\u7372\u5f97\u6838\u51c6\uff0c\u5145\u5206\u9ad4\u73fe\u4e86\u6211\u5011\u7684\u79d1\u5b78\u8207\u54c1\u8cea\u5718\u968a\u5728 CellDx-Tissue \u5e73\u53f0\u958b\u767c\u904e\u7a0b\u4e2d\u6240\u5c55\u73fe\u51fa\u7684\u4e00\u81f4\u6027\u3001\u56b4\u8b39\u6027\u53ca\u4ee5\u81e8\u5e8a\u70ba\u5c0e\u5411\u7684\u8a2d\u8a08\u7406\u5ff5\u3002 \u6211\u5011\u71b1\u5207\u671f\u5f85\u5c07\u9019\u9805\u8b8a\u9769\u6027\u7684\u7cbe\u6e96\u816b\u7624\u91ab\u5b78\u89e3\u6c7a\u65b9\u6848\u63a8\u5ee3\u81f3\u5168\u7403\u5e02\u5834\uff0c\u8b93\u66f4\u591a\u764c\u75c7\u75c5\u60a3\u8005\u53d7\u60e0\u3002\u300d \u95dc\u65bc Datar Cancer Genetics Datar Cancer Genetics (DCG) \u662f\u4e00\u9593\u5168\u7403\u6027\u3001\u7531\u4eba\u5de5\u667a\u80fd\u9a45\u52d5\u7684\u7cbe\u6e96\u816b\u7624\u91ab\u5b78\u516c\u53f8\uff0c\u5c08\u6ce8\u65bc\u958b\u767c\u53ca\u63d0\u4f9b\u5148\u9032\u7684\u764c\u75c7\u8a3a\u65b7\u6280\u8853\uff0c\u5305\u62ec\u7528\u65bc\u65e9\u671f\u6aa2\u6e2c\u3001\u6cbb\u7642\u9078\u64c7\u548c\u764c\u75c7\u76e3\u6e2c\u7684\u975e\u4fb5\u5165\u6027\u6db2\u614b\u5207\u7247\u53ca\u4ee5\u7d44\u7e54\u70ba\u57fa\u790e\u7684\u591a\u9ad4\u5b78\u89e3\u6c7a\u65b9\u6848\u3002 DCG \u64c1\u6709\u7372\u5f97 UKAS\u3001CAP \u53ca CLIA \u8a8d\u8b49\u7684\u5be6\u9a57\u5ba4\uff0c\u696d\u52d9\u8db3\u8de1\u904d\u53ca\u82f1\u570b\u3001\u6b50\u76df\u3001\u7f8e\u570b\u3001\u6d77\u7063\u5408\u4f5c\u59d4\u54e1\u6703\u570b\u5bb6\u548c\u4e9e\u6d32\u3002 DCG \u8207\u5168\u7403\u81e8\u5e8a\u91ab\u751f\u53ca\u764c\u75c7\u4e2d\u5fc3\u5408\u4f5c\uff0c\u70ba\u5be6\u9ad4\u5668\u5b98\u764c\u75c7\u60a3\u8005\u63d0\u4f9b\u500b\u4eba\u5c08\u5c6c\u7684\u764c\u75c7\u8b77\u7406\u3002 \u7db2\u9801\uff1ahttps:\\\/\\\/datarpgx.com\\\/celldx-tissue\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=436020#breadcrumb\"},\"inLanguage\":\"zh-TW\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=436020\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-TW\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=436020#primaryimage\",\"url\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/wp-content\\\/uploads\\\/2026\\\/05\\\/Datar_Cancer_Genetics_US_FDA.jpg\",\"contentUrl\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/wp-content\\\/uploads\\\/2026\\\/05\\\/Datar_Cancer_Genetics_US_FDA.jpg\",\"width\":400,\"height\":400},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=436020#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"\u9996\u9801\",\"item\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Datar Cancer Genetics \u7684 CellDx-Tissue \u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u70ba\u8a72\u9805\u5229\u7528 DNA \u8207 RNA \u9032\u884c\u7684\u5be6\u9ad4\u816b\u7624\u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u6aa2\u6e2c\u5beb\u4e0b\u91cc\u7a0b\u7891\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#website\",\"url\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/\",\"name\":\"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\",\"description\":\"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831PingtungTimes\uff0c\u6700\u95dc\u5fc3\u5728\u5730\u7684\u5a92\u9ad4\",\"publisher\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"zh-TW\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#organization\",\"name\":\"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\",\"url\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-TW\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/wp-content\\\/uploads\\\/2023\\\/02\\\/logo-150.png\",\"contentUrl\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/wp-content\\\/uploads\\\/2023\\\/02\\\/logo-150.png\",\"width\":150,\"height\":150,\"caption\":\"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\"},\"image\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/pingtungnews\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#\\\/schema\\\/person\\\/683b937f29ec1537972f6c41e22a2cf3\",\"name\":\"\u7f8e\u901a\u793e\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-TW\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/6c21e24ce33ca5d4572e343395adac2bbef44ff7035a74ea2cab2443c7f0a5f3?s=96&d=blank&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/6c21e24ce33ca5d4572e343395adac2bbef44ff7035a74ea2cab2443c7f0a5f3?s=96&d=blank&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/6c21e24ce33ca5d4572e343395adac2bbef44ff7035a74ea2cab2443c7f0a5f3?s=96&d=blank&r=g\",\"caption\":\"\u7f8e\u901a\u793e\"},\"url\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?author=16\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Datar Cancer Genetics \u7684 CellDx-Tissue \u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u70ba\u8a72\u9805\u5229\u7528 DNA \u8207 RNA \u9032\u884c\u7684\u5be6\u9ad4\u816b\u7624\u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u6aa2\u6e2c\u5beb\u4e0b\u91cc\u7a0b\u7891 - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","description":"\u662f\u6b21\u6838\u51c6\u8a8d\u5b9a\u4e86 CellDx-Tissue \u7684 DNA \u8207 RNA \u96d9\u5206\u6790\u7269\u5de5\u4f5c\u6d41\u7a0b\uff0c\u6db5\u84cb 517 \u500b\u8207\u764c\u75c7\u76f8\u95dc\u7684\u57fa\u56e0\uff0c\u4e26\u80fd\u4ee5 RNA \u5c64\u7d1a\u8b49\u64da\u5075\u6e2c ALK\u3001RET \u8207 ROS1 \u7b49\u95dc\u9375\u878d\u5408\u57fa\u56e0 \u5370\u5ea6\u7d0d\u897f\u514b2026\u5e745\u670815\u65e5 \/\u7f8e\u901a\u793e\/ -- \u5168\u7403\u7cbe\u6e96\u816b\u7624\u91ab\u5b78\u516c\u53f8 Datar Cancer Genetics (DCG) \u4eca\u65e5\u5ba3\u4f48\uff0c\u5176\u9069\u7528\u65bc\u6240\u6709\u5be6\u9ad4\u816b\u7624\u3001\u4ee5\u7d44\u7e54\u70ba\u57fa\u790e\u7684\u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790 (comprehensive genomic profiling\uff0c\u7c21\u7a31 CGP) \u6aa2\u6e2c\u65b9\u6cd5 CellDx-Tissue\uff0c\u5df2\u7372\u5f97\u7f8e\u570b\u98df\u54c1\u53ca\u85e5\u7269\u7ba1\u7406\u5c40\uff08US Food and Drug Administration\uff0c\u7c21\u7a31\u7f8e\u570b FDA\uff09\u7684\u6838\u51c6\u3002      CellDx-Tissue- \u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u6aa2\u6e2c  \u662f\u6b21\u6838\u51c6\u9032\u4e00\u6b65\u978f\u56fa DCG \u5728\u63d0\u4f9b\u7a81\u7834\u6027\u5e73\u53f0\u65b9\u9762\u7684\u5730\u4f4d\uff0c\u8a72\u5e73\u53f0\u65e8\u5728\u5354\u52a9\u5168\u7403\u816b\u7624\u79d1\u91ab\u751f\u6839\u64da\u5c08\u696d\u6307\u5f15\u4f5c\u51fa\u500b\u4eba\u5c08\u5c6c\u7684\u81e8\u5e8a\u7ba1\u7406\u6c7a\u7b56\uff0c\u4e26\u4e14\u8207\u8a72\u516c\u53f8\u65e9\u524d\u91dd\u5c0d\u5176\u6db2\u614b\u5207\u7247\u5e73\u53f0\u800c\u7372\u5f97\u7684\u7f8e\u570b FDA \u7a81\u7834\u6027\u91ab\u7642\u5668\u6750\u8a8d\u5b9a (US FDA Breakthrough Device Designations) \u4e92\u76f8\u88dc\u8db3\u3002 \u95dc\u65bc CellDx-Tissue CellDx-Tissue \u662f\u4e00\u7a2e\u5b9a\u6027\u9ad4\u5916\u8a3a\u65b7 (IVD) \u6aa2\u6e2c\uff0c\u5b83\u5229\u7528\u6a19\u9776\u5f0f\u6b21\u4e16\u4ee3\u5b9a\u5e8f (NGS) \u6280\u8853\uff0c\u5c0d\u5f9e\u798f\u723e\u99ac\u6797\u56fa\u5b9a\u77f3\u881f\u5305\u57cb (FFPE) \u5be6\u9ad4\u816b\u7624\u60a3\u8005\u7684\u816b\u7624\u7d44\u7e54\u4e2d\u5206\u96e2\u7684 DNA \u53ca RNA \u9032\u884c\u5206\u6790\u3002 \u6b64\u6aa2\u6e2c\u5206\u6790 517 \u500b\u8207\u764c\u75c7\u76f8\u95dc\u7684\u57fa\u56e0\uff0c\u76ee\u7684\u5728\u65bc\u63d0\u4f9b\u6709\u95dc\u9ad4\u7d30\u80de\u55ae\u6838\u82f7\u9178\u8b8a\u7570 (SNV)\u3001\u5c0f\u7247\u6bb5\u63d2\u5165\u548c\u7f3a\u5931 (InDels)\u3001ERBB2 \u57fa\u56e0\u64f4\u589e\u8207\u6d89\u53ca ALK\u3001RET \u548c ROS1 \u7684\u57fa\u56e0\u878d\u5408\u8cc7\u8a0a\u3002 CellDx-Tissue \u70ba\u55ae\u4e00\u5be6\u9a57\u5ba4\u6aa2\u6e2c\uff0c\u7531 Datar Cancer Genetics \u65d7\u4e0b\u7372\u5f97 CAP \u53ca CLIA \u8a8d\u8b49\u7684\u5be6\u9a57\u5ba4\u9032\u884c\u3002 \u91cd\u8981\u610f\u7fa9 \u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u5df2\u6210\u70ba\u5be6\u9ad4\u816b\u7624\u81e8\u5e8a\u7ba1\u7406\u7684\u6838\u5fc3\u7d44\u6210\u90e8\u5206\uff0c\u5354\u52a9\u81e8\u5e8a\u91ab\u751f\u5728\u591a\u7a2e\u764c\u75c7\u985e\u578b\u4e2d\u5168\u9762\u89e3\u6790\u816b\u7624\u57fa\u56e0\u9ad4\u8b8a\u7570\u3002 \u7f8e\u570b FDA \u7684\u6838\u51c6\u904e\u7a0b\u65e2\u7e41\u8907\u4ea6\u56b4\u683c\uff0c\u6db5\u84cb\u5206\u6790\u3001\u81e8\u5e8a\u53ca\u8cc7\u8a0a\u79d1\u6280\u7b49\u9818\u57df\u3002 \u00a0 \u9019\u6b21\u6838\u51c6\u978f\u56fa\u4e86 DCG \u7684\u5730\u4f4d\uff0c\u4ee4\u516c\u53f8\u5f97\u4ee5\u5728\u81e8\u5e8a\u7ba1\u7406\u652f\u63f4\u3001\u8f49\u5316\u7814\u7a76\u8207\u751f\u7269\u6a19\u8a18\u958b\u767c\u7b49\u9818\u57df\uff0c\u8207\u570b\u969b\u81e8\u5e8a\u3001\u5b78\u8853\u53ca\u751f\u7269\u88fd\u85e5\u5925\u4f34\u65bc\u5171\u540c\u7684\u6cd5\u898f\u57fa\u790e\u4e0a\u5c55\u958b\u5408\u4f5c\u3002 \u5168\u7403\u7b56\u7565\u8207\u696d\u52d9\u62d3\u5c55\u9ad8\u7d1a\u7e3d\u76e3 Vineet Datta \u535a\u58eb\u8868\u793a\uff1a\u300cCellDx-Tissue \u6aa2\u6e2c\u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u70ba DCG \u6240\u63d0\u4f9b\u7684\u91cd\u8981\u89e3\u6c7a\u65b9\u6848\u589e\u6dfb\u4e86\u300c\u9ec3\u91d1\u6a19\u6e96\u300d\u7d1a\u5225\u7684\u76e3\u7ba1\u8a8d\u53ef\u3002 CellDx-Tissue \u5f4c\u88dc\u4e86\u57fa\u56e0\u9ad4\u8907\u96dc\u6027\u8207\u81e8\u5e8a\u6c7a\u7b56\u4e4b\u9593\u7684\u7f3a\u53e3\uff0c\u5728\u6cbb\u7642\u65b9\u6cd5\u8fc5\u901f\u6f14\u8b8a\u7684\u6642\u4ee3\u4e2d\uff0c\u70ba\u60a3\u8005\u63d0\u4f9b\u4e86\u66f4\u5ee3\u6cdb\u7684\u9078\u64c7\u3002 \u80fd\u5c07\u9019\u9805\u6280\u8853\u5e36\u7d66\u5168\u7403\u7684\u816b\u7624\u79d1\u91ab\u751f\uff0c\u4ee4\u6211\u5011\u611f\u5230\u76f8\u7576\u81ea\u8c6a\u3002\u300d \u96c6\u5718\u91ab\u7642\u4e8b\u52d9\u9ad8\u7d1a\u7e3d\u76e3 Darshana Patil \u535a\u58eb\u5247\u8868\u793a\uff1a\u300c\u6211\u5011\u4ee5\u7d44\u7e54\u70ba\u57fa\u790e\u7684\u57fa\u56e0\u9ad4\u6aa2\u6e2c\u65b9\u6848\u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u662f\u5c0d\u672c\u516c\u53f8\u79d1\u5b78\u6280\u8853\u548c\u54c1\u8cea\u7cfb\u7d71\u7684\u5be6\u8cea\u9a57\u8b49\u3002 \u6b64\u8209\u4ee4\u6211\u5011\u5f97\u4ee5\u70ba\u816b\u7624\u79d1\u91ab\u751f\u63d0\u4f9b\u53ef\u9760\u3001\u6a19\u6e96\u5316\u7684\u57fa\u56e0\u9ad4\u8cc7\u8a0a\uff0c\u70ba\u8907\u96dc\u7684\u6cbb\u7642\u6c7a\u7b56\u63d0\u4f9b\u6307\u5f15\uff0c\u4e26\u4e14\u978f\u56fa\u4e86\u6211\u5011\u7684\u627f\u8afe\uff0c\u5c31\u662f\u8981\u7d50\u5408\u5148\u9032\u57fa\u56e0\u9ad4\u6280\u8853\u3001\u56b4\u8b39\u79d1\u5b78\u65b9\u6cd5\u8207\u81e8\u5e8a\u5be6\u52d9\u50f9\u503c\u4f86\u670d\u52d9\u764c\u75c7\u75c5\u60a3\u8005\u3002\u300d \u7814\u767c\u8207\u5275\u65b0\u7e3d\u76e3 Dadasaheb Akolkar \u535a\u58eb\u88dc\u5145\u9053\uff1a\u300c\u9019\u6b21\u7372\u5f97\u6838\u51c6\uff0c\u5145\u5206\u9ad4\u73fe\u4e86\u6211\u5011\u7684\u79d1\u5b78\u8207\u54c1\u8cea\u5718\u968a\u5728 CellDx-Tissue \u5e73\u53f0\u958b\u767c\u904e\u7a0b\u4e2d\u6240\u5c55\u73fe\u51fa\u7684\u4e00\u81f4\u6027\u3001\u56b4\u8b39\u6027\u53ca\u4ee5\u81e8\u5e8a\u70ba\u5c0e\u5411\u7684\u8a2d\u8a08\u7406\u5ff5\u3002 \u6211\u5011\u71b1\u5207\u671f\u5f85\u5c07\u9019\u9805\u8b8a\u9769\u6027\u7684\u7cbe\u6e96\u816b\u7624\u91ab\u5b78\u89e3\u6c7a\u65b9\u6848\u63a8\u5ee3\u81f3\u5168\u7403\u5e02\u5834\uff0c\u8b93\u66f4\u591a\u764c\u75c7\u75c5\u60a3\u8005\u53d7\u60e0\u3002\u300d \u95dc\u65bc Datar Cancer Genetics Datar Cancer Genetics (DCG) \u662f\u4e00\u9593\u5168\u7403\u6027\u3001\u7531\u4eba\u5de5\u667a\u80fd\u9a45\u52d5\u7684\u7cbe\u6e96\u816b\u7624\u91ab\u5b78\u516c\u53f8\uff0c\u5c08\u6ce8\u65bc\u958b\u767c\u53ca\u63d0\u4f9b\u5148\u9032\u7684\u764c\u75c7\u8a3a\u65b7\u6280\u8853\uff0c\u5305\u62ec\u7528\u65bc\u65e9\u671f\u6aa2\u6e2c\u3001\u6cbb\u7642\u9078\u64c7\u548c\u764c\u75c7\u76e3\u6e2c\u7684\u975e\u4fb5\u5165\u6027\u6db2\u614b\u5207\u7247\u53ca\u4ee5\u7d44\u7e54\u70ba\u57fa\u790e\u7684\u591a\u9ad4\u5b78\u89e3\u6c7a\u65b9\u6848\u3002 DCG \u64c1\u6709\u7372\u5f97 UKAS\u3001CAP \u53ca CLIA \u8a8d\u8b49\u7684\u5be6\u9a57\u5ba4\uff0c\u696d\u52d9\u8db3\u8de1\u904d\u53ca\u82f1\u570b\u3001\u6b50\u76df\u3001\u7f8e\u570b\u3001\u6d77\u7063\u5408\u4f5c\u59d4\u54e1\u6703\u570b\u5bb6\u548c\u4e9e\u6d32\u3002 DCG \u8207\u5168\u7403\u81e8\u5e8a\u91ab\u751f\u53ca\u764c\u75c7\u4e2d\u5fc3\u5408\u4f5c\uff0c\u70ba\u5be6\u9ad4\u5668\u5b98\u764c\u75c7\u60a3\u8005\u63d0\u4f9b\u500b\u4eba\u5c08\u5c6c\u7684\u764c\u75c7\u8b77\u7406\u3002 \u7db2\u9801\uff1ahttps:\/\/datarpgx.com\/celldx-tissue","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/pingtungtimes.com.tw\/?p=436020","og_locale":"zh_TW","og_type":"article","og_title":"Datar Cancer Genetics \u7684 CellDx-Tissue \u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u70ba\u8a72\u9805\u5229\u7528 DNA \u8207 RNA \u9032\u884c\u7684\u5be6\u9ad4\u816b\u7624\u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u6aa2\u6e2c\u5beb\u4e0b\u91cc\u7a0b\u7891 - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","og_description":"\u662f\u6b21\u6838\u51c6\u8a8d\u5b9a\u4e86 CellDx-Tissue \u7684 DNA \u8207 RNA \u96d9\u5206\u6790\u7269\u5de5\u4f5c\u6d41\u7a0b\uff0c\u6db5\u84cb 517 \u500b\u8207\u764c\u75c7\u76f8\u95dc\u7684\u57fa\u56e0\uff0c\u4e26\u80fd\u4ee5 RNA \u5c64\u7d1a\u8b49\u64da\u5075\u6e2c ALK\u3001RET \u8207 ROS1 \u7b49\u95dc\u9375\u878d\u5408\u57fa\u56e0 \u5370\u5ea6\u7d0d\u897f\u514b2026\u5e745\u670815\u65e5 \/\u7f8e\u901a\u793e\/ -- \u5168\u7403\u7cbe\u6e96\u816b\u7624\u91ab\u5b78\u516c\u53f8 Datar Cancer Genetics (DCG) \u4eca\u65e5\u5ba3\u4f48\uff0c\u5176\u9069\u7528\u65bc\u6240\u6709\u5be6\u9ad4\u816b\u7624\u3001\u4ee5\u7d44\u7e54\u70ba\u57fa\u790e\u7684\u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790 (comprehensive genomic profiling\uff0c\u7c21\u7a31 CGP) \u6aa2\u6e2c\u65b9\u6cd5 CellDx-Tissue\uff0c\u5df2\u7372\u5f97\u7f8e\u570b\u98df\u54c1\u53ca\u85e5\u7269\u7ba1\u7406\u5c40\uff08US Food and Drug Administration\uff0c\u7c21\u7a31\u7f8e\u570b FDA\uff09\u7684\u6838\u51c6\u3002      CellDx-Tissue- \u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u6aa2\u6e2c  \u662f\u6b21\u6838\u51c6\u9032\u4e00\u6b65\u978f\u56fa DCG \u5728\u63d0\u4f9b\u7a81\u7834\u6027\u5e73\u53f0\u65b9\u9762\u7684\u5730\u4f4d\uff0c\u8a72\u5e73\u53f0\u65e8\u5728\u5354\u52a9\u5168\u7403\u816b\u7624\u79d1\u91ab\u751f\u6839\u64da\u5c08\u696d\u6307\u5f15\u4f5c\u51fa\u500b\u4eba\u5c08\u5c6c\u7684\u81e8\u5e8a\u7ba1\u7406\u6c7a\u7b56\uff0c\u4e26\u4e14\u8207\u8a72\u516c\u53f8\u65e9\u524d\u91dd\u5c0d\u5176\u6db2\u614b\u5207\u7247\u5e73\u53f0\u800c\u7372\u5f97\u7684\u7f8e\u570b FDA \u7a81\u7834\u6027\u91ab\u7642\u5668\u6750\u8a8d\u5b9a (US FDA Breakthrough Device Designations) \u4e92\u76f8\u88dc\u8db3\u3002 \u95dc\u65bc CellDx-Tissue CellDx-Tissue \u662f\u4e00\u7a2e\u5b9a\u6027\u9ad4\u5916\u8a3a\u65b7 (IVD) \u6aa2\u6e2c\uff0c\u5b83\u5229\u7528\u6a19\u9776\u5f0f\u6b21\u4e16\u4ee3\u5b9a\u5e8f (NGS) \u6280\u8853\uff0c\u5c0d\u5f9e\u798f\u723e\u99ac\u6797\u56fa\u5b9a\u77f3\u881f\u5305\u57cb (FFPE) \u5be6\u9ad4\u816b\u7624\u60a3\u8005\u7684\u816b\u7624\u7d44\u7e54\u4e2d\u5206\u96e2\u7684 DNA \u53ca RNA \u9032\u884c\u5206\u6790\u3002 \u6b64\u6aa2\u6e2c\u5206\u6790 517 \u500b\u8207\u764c\u75c7\u76f8\u95dc\u7684\u57fa\u56e0\uff0c\u76ee\u7684\u5728\u65bc\u63d0\u4f9b\u6709\u95dc\u9ad4\u7d30\u80de\u55ae\u6838\u82f7\u9178\u8b8a\u7570 (SNV)\u3001\u5c0f\u7247\u6bb5\u63d2\u5165\u548c\u7f3a\u5931 (InDels)\u3001ERBB2 \u57fa\u56e0\u64f4\u589e\u8207\u6d89\u53ca ALK\u3001RET \u548c ROS1 \u7684\u57fa\u56e0\u878d\u5408\u8cc7\u8a0a\u3002 CellDx-Tissue \u70ba\u55ae\u4e00\u5be6\u9a57\u5ba4\u6aa2\u6e2c\uff0c\u7531 Datar Cancer Genetics \u65d7\u4e0b\u7372\u5f97 CAP \u53ca CLIA \u8a8d\u8b49\u7684\u5be6\u9a57\u5ba4\u9032\u884c\u3002 \u91cd\u8981\u610f\u7fa9 \u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u5df2\u6210\u70ba\u5be6\u9ad4\u816b\u7624\u81e8\u5e8a\u7ba1\u7406\u7684\u6838\u5fc3\u7d44\u6210\u90e8\u5206\uff0c\u5354\u52a9\u81e8\u5e8a\u91ab\u751f\u5728\u591a\u7a2e\u764c\u75c7\u985e\u578b\u4e2d\u5168\u9762\u89e3\u6790\u816b\u7624\u57fa\u56e0\u9ad4\u8b8a\u7570\u3002 \u7f8e\u570b FDA \u7684\u6838\u51c6\u904e\u7a0b\u65e2\u7e41\u8907\u4ea6\u56b4\u683c\uff0c\u6db5\u84cb\u5206\u6790\u3001\u81e8\u5e8a\u53ca\u8cc7\u8a0a\u79d1\u6280\u7b49\u9818\u57df\u3002 \u00a0 \u9019\u6b21\u6838\u51c6\u978f\u56fa\u4e86 DCG \u7684\u5730\u4f4d\uff0c\u4ee4\u516c\u53f8\u5f97\u4ee5\u5728\u81e8\u5e8a\u7ba1\u7406\u652f\u63f4\u3001\u8f49\u5316\u7814\u7a76\u8207\u751f\u7269\u6a19\u8a18\u958b\u767c\u7b49\u9818\u57df\uff0c\u8207\u570b\u969b\u81e8\u5e8a\u3001\u5b78\u8853\u53ca\u751f\u7269\u88fd\u85e5\u5925\u4f34\u65bc\u5171\u540c\u7684\u6cd5\u898f\u57fa\u790e\u4e0a\u5c55\u958b\u5408\u4f5c\u3002 \u5168\u7403\u7b56\u7565\u8207\u696d\u52d9\u62d3\u5c55\u9ad8\u7d1a\u7e3d\u76e3 Vineet Datta \u535a\u58eb\u8868\u793a\uff1a\u300cCellDx-Tissue \u6aa2\u6e2c\u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u70ba DCG \u6240\u63d0\u4f9b\u7684\u91cd\u8981\u89e3\u6c7a\u65b9\u6848\u589e\u6dfb\u4e86\u300c\u9ec3\u91d1\u6a19\u6e96\u300d\u7d1a\u5225\u7684\u76e3\u7ba1\u8a8d\u53ef\u3002 CellDx-Tissue \u5f4c\u88dc\u4e86\u57fa\u56e0\u9ad4\u8907\u96dc\u6027\u8207\u81e8\u5e8a\u6c7a\u7b56\u4e4b\u9593\u7684\u7f3a\u53e3\uff0c\u5728\u6cbb\u7642\u65b9\u6cd5\u8fc5\u901f\u6f14\u8b8a\u7684\u6642\u4ee3\u4e2d\uff0c\u70ba\u60a3\u8005\u63d0\u4f9b\u4e86\u66f4\u5ee3\u6cdb\u7684\u9078\u64c7\u3002 \u80fd\u5c07\u9019\u9805\u6280\u8853\u5e36\u7d66\u5168\u7403\u7684\u816b\u7624\u79d1\u91ab\u751f\uff0c\u4ee4\u6211\u5011\u611f\u5230\u76f8\u7576\u81ea\u8c6a\u3002\u300d \u96c6\u5718\u91ab\u7642\u4e8b\u52d9\u9ad8\u7d1a\u7e3d\u76e3 Darshana Patil \u535a\u58eb\u5247\u8868\u793a\uff1a\u300c\u6211\u5011\u4ee5\u7d44\u7e54\u70ba\u57fa\u790e\u7684\u57fa\u56e0\u9ad4\u6aa2\u6e2c\u65b9\u6848\u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u662f\u5c0d\u672c\u516c\u53f8\u79d1\u5b78\u6280\u8853\u548c\u54c1\u8cea\u7cfb\u7d71\u7684\u5be6\u8cea\u9a57\u8b49\u3002 \u6b64\u8209\u4ee4\u6211\u5011\u5f97\u4ee5\u70ba\u816b\u7624\u79d1\u91ab\u751f\u63d0\u4f9b\u53ef\u9760\u3001\u6a19\u6e96\u5316\u7684\u57fa\u56e0\u9ad4\u8cc7\u8a0a\uff0c\u70ba\u8907\u96dc\u7684\u6cbb\u7642\u6c7a\u7b56\u63d0\u4f9b\u6307\u5f15\uff0c\u4e26\u4e14\u978f\u56fa\u4e86\u6211\u5011\u7684\u627f\u8afe\uff0c\u5c31\u662f\u8981\u7d50\u5408\u5148\u9032\u57fa\u56e0\u9ad4\u6280\u8853\u3001\u56b4\u8b39\u79d1\u5b78\u65b9\u6cd5\u8207\u81e8\u5e8a\u5be6\u52d9\u50f9\u503c\u4f86\u670d\u52d9\u764c\u75c7\u75c5\u60a3\u8005\u3002\u300d \u7814\u767c\u8207\u5275\u65b0\u7e3d\u76e3 Dadasaheb Akolkar \u535a\u58eb\u88dc\u5145\u9053\uff1a\u300c\u9019\u6b21\u7372\u5f97\u6838\u51c6\uff0c\u5145\u5206\u9ad4\u73fe\u4e86\u6211\u5011\u7684\u79d1\u5b78\u8207\u54c1\u8cea\u5718\u968a\u5728 CellDx-Tissue \u5e73\u53f0\u958b\u767c\u904e\u7a0b\u4e2d\u6240\u5c55\u73fe\u51fa\u7684\u4e00\u81f4\u6027\u3001\u56b4\u8b39\u6027\u53ca\u4ee5\u81e8\u5e8a\u70ba\u5c0e\u5411\u7684\u8a2d\u8a08\u7406\u5ff5\u3002 \u6211\u5011\u71b1\u5207\u671f\u5f85\u5c07\u9019\u9805\u8b8a\u9769\u6027\u7684\u7cbe\u6e96\u816b\u7624\u91ab\u5b78\u89e3\u6c7a\u65b9\u6848\u63a8\u5ee3\u81f3\u5168\u7403\u5e02\u5834\uff0c\u8b93\u66f4\u591a\u764c\u75c7\u75c5\u60a3\u8005\u53d7\u60e0\u3002\u300d \u95dc\u65bc Datar Cancer Genetics Datar Cancer Genetics (DCG) \u662f\u4e00\u9593\u5168\u7403\u6027\u3001\u7531\u4eba\u5de5\u667a\u80fd\u9a45\u52d5\u7684\u7cbe\u6e96\u816b\u7624\u91ab\u5b78\u516c\u53f8\uff0c\u5c08\u6ce8\u65bc\u958b\u767c\u53ca\u63d0\u4f9b\u5148\u9032\u7684\u764c\u75c7\u8a3a\u65b7\u6280\u8853\uff0c\u5305\u62ec\u7528\u65bc\u65e9\u671f\u6aa2\u6e2c\u3001\u6cbb\u7642\u9078\u64c7\u548c\u764c\u75c7\u76e3\u6e2c\u7684\u975e\u4fb5\u5165\u6027\u6db2\u614b\u5207\u7247\u53ca\u4ee5\u7d44\u7e54\u70ba\u57fa\u790e\u7684\u591a\u9ad4\u5b78\u89e3\u6c7a\u65b9\u6848\u3002 DCG \u64c1\u6709\u7372\u5f97 UKAS\u3001CAP \u53ca CLIA \u8a8d\u8b49\u7684\u5be6\u9a57\u5ba4\uff0c\u696d\u52d9\u8db3\u8de1\u904d\u53ca\u82f1\u570b\u3001\u6b50\u76df\u3001\u7f8e\u570b\u3001\u6d77\u7063\u5408\u4f5c\u59d4\u54e1\u6703\u570b\u5bb6\u548c\u4e9e\u6d32\u3002 DCG \u8207\u5168\u7403\u81e8\u5e8a\u91ab\u751f\u53ca\u764c\u75c7\u4e2d\u5fc3\u5408\u4f5c\uff0c\u70ba\u5be6\u9ad4\u5668\u5b98\u764c\u75c7\u60a3\u8005\u63d0\u4f9b\u500b\u4eba\u5c08\u5c6c\u7684\u764c\u75c7\u8b77\u7406\u3002 \u7db2\u9801\uff1ahttps:\/\/datarpgx.com\/celldx-tissue","og_url":"https:\/\/pingtungtimes.com.tw\/?p=436020","og_site_name":"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","article_publisher":"https:\/\/www.facebook.com\/pingtungnews","article_published_time":"2026-05-15T14:00:00+00:00","og_image":[{"width":3000,"height":1990,"url":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2023\/02\/logo-150.png","type":"image\/jpeg"}],"author":"\u7f8e\u901a\u793e","twitter_card":"summary_large_image","twitter_misc":{"\u4f5c\u8005:":"\u7f8e\u901a\u793e"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"NewsArticle","@id":"https:\/\/pingtungtimes.com.tw\/?p=436020#article","isPartOf":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=436020"},"author":{"name":"\u7f8e\u901a\u793e","@id":"https:\/\/pingtungtimes.com.tw\/#\/schema\/person\/683b937f29ec1537972f6c41e22a2cf3"},"headline":"Datar Cancer Genetics \u7684 CellDx-Tissue \u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u70ba\u8a72\u9805\u5229\u7528 DNA \u8207 RNA \u9032\u884c\u7684\u5be6\u9ad4\u816b\u7624\u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u6aa2\u6e2c\u5beb\u4e0b\u91cc\u7a0b\u7891","datePublished":"2026-05-15T14:00:00+00:00","mainEntityOfPage":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=436020"},"wordCount":87,"publisher":{"@id":"https:\/\/pingtungtimes.com.tw\/#organization"},"image":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=436020#primaryimage"},"thumbnailUrl":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2026\/05\/Datar_Cancer_Genetics_US_FDA.jpg","articleSection":["\u7f8e\u901a\u793e"],"inLanguage":"zh-TW"},{"@type":"WebPage","@id":"https:\/\/pingtungtimes.com.tw\/?p=436020","url":"https:\/\/pingtungtimes.com.tw\/?p=436020","name":"Datar Cancer Genetics \u7684 CellDx-Tissue \u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u70ba\u8a72\u9805\u5229\u7528 DNA \u8207 RNA \u9032\u884c\u7684\u5be6\u9ad4\u816b\u7624\u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u6aa2\u6e2c\u5beb\u4e0b\u91cc\u7a0b\u7891 - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","isPartOf":{"@id":"https:\/\/pingtungtimes.com.tw\/#website"},"primaryImageOfPage":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=436020#primaryimage"},"image":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=436020#primaryimage"},"thumbnailUrl":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2026\/05\/Datar_Cancer_Genetics_US_FDA.jpg","datePublished":"2026-05-15T14:00:00+00:00","description":"\u662f\u6b21\u6838\u51c6\u8a8d\u5b9a\u4e86 CellDx-Tissue \u7684 DNA \u8207 RNA \u96d9\u5206\u6790\u7269\u5de5\u4f5c\u6d41\u7a0b\uff0c\u6db5\u84cb 517 \u500b\u8207\u764c\u75c7\u76f8\u95dc\u7684\u57fa\u56e0\uff0c\u4e26\u80fd\u4ee5 RNA \u5c64\u7d1a\u8b49\u64da\u5075\u6e2c ALK\u3001RET \u8207 ROS1 \u7b49\u95dc\u9375\u878d\u5408\u57fa\u56e0 \u5370\u5ea6\u7d0d\u897f\u514b2026\u5e745\u670815\u65e5 \/\u7f8e\u901a\u793e\/ -- \u5168\u7403\u7cbe\u6e96\u816b\u7624\u91ab\u5b78\u516c\u53f8 Datar Cancer Genetics (DCG) \u4eca\u65e5\u5ba3\u4f48\uff0c\u5176\u9069\u7528\u65bc\u6240\u6709\u5be6\u9ad4\u816b\u7624\u3001\u4ee5\u7d44\u7e54\u70ba\u57fa\u790e\u7684\u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790 (comprehensive genomic profiling\uff0c\u7c21\u7a31 CGP) \u6aa2\u6e2c\u65b9\u6cd5 CellDx-Tissue\uff0c\u5df2\u7372\u5f97\u7f8e\u570b\u98df\u54c1\u53ca\u85e5\u7269\u7ba1\u7406\u5c40\uff08US Food and Drug Administration\uff0c\u7c21\u7a31\u7f8e\u570b FDA\uff09\u7684\u6838\u51c6\u3002 CellDx-Tissue- \u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u6aa2\u6e2c \u662f\u6b21\u6838\u51c6\u9032\u4e00\u6b65\u978f\u56fa DCG \u5728\u63d0\u4f9b\u7a81\u7834\u6027\u5e73\u53f0\u65b9\u9762\u7684\u5730\u4f4d\uff0c\u8a72\u5e73\u53f0\u65e8\u5728\u5354\u52a9\u5168\u7403\u816b\u7624\u79d1\u91ab\u751f\u6839\u64da\u5c08\u696d\u6307\u5f15\u4f5c\u51fa\u500b\u4eba\u5c08\u5c6c\u7684\u81e8\u5e8a\u7ba1\u7406\u6c7a\u7b56\uff0c\u4e26\u4e14\u8207\u8a72\u516c\u53f8\u65e9\u524d\u91dd\u5c0d\u5176\u6db2\u614b\u5207\u7247\u5e73\u53f0\u800c\u7372\u5f97\u7684\u7f8e\u570b FDA \u7a81\u7834\u6027\u91ab\u7642\u5668\u6750\u8a8d\u5b9a (US FDA Breakthrough Device Designations) \u4e92\u76f8\u88dc\u8db3\u3002 \u95dc\u65bc CellDx-Tissue CellDx-Tissue \u662f\u4e00\u7a2e\u5b9a\u6027\u9ad4\u5916\u8a3a\u65b7 (IVD) \u6aa2\u6e2c\uff0c\u5b83\u5229\u7528\u6a19\u9776\u5f0f\u6b21\u4e16\u4ee3\u5b9a\u5e8f (NGS) \u6280\u8853\uff0c\u5c0d\u5f9e\u798f\u723e\u99ac\u6797\u56fa\u5b9a\u77f3\u881f\u5305\u57cb (FFPE) \u5be6\u9ad4\u816b\u7624\u60a3\u8005\u7684\u816b\u7624\u7d44\u7e54\u4e2d\u5206\u96e2\u7684 DNA \u53ca RNA \u9032\u884c\u5206\u6790\u3002 \u6b64\u6aa2\u6e2c\u5206\u6790 517 \u500b\u8207\u764c\u75c7\u76f8\u95dc\u7684\u57fa\u56e0\uff0c\u76ee\u7684\u5728\u65bc\u63d0\u4f9b\u6709\u95dc\u9ad4\u7d30\u80de\u55ae\u6838\u82f7\u9178\u8b8a\u7570 (SNV)\u3001\u5c0f\u7247\u6bb5\u63d2\u5165\u548c\u7f3a\u5931 (InDels)\u3001ERBB2 \u57fa\u56e0\u64f4\u589e\u8207\u6d89\u53ca ALK\u3001RET \u548c ROS1 \u7684\u57fa\u56e0\u878d\u5408\u8cc7\u8a0a\u3002 CellDx-Tissue \u70ba\u55ae\u4e00\u5be6\u9a57\u5ba4\u6aa2\u6e2c\uff0c\u7531 Datar Cancer Genetics \u65d7\u4e0b\u7372\u5f97 CAP \u53ca CLIA \u8a8d\u8b49\u7684\u5be6\u9a57\u5ba4\u9032\u884c\u3002 \u91cd\u8981\u610f\u7fa9 \u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u5df2\u6210\u70ba\u5be6\u9ad4\u816b\u7624\u81e8\u5e8a\u7ba1\u7406\u7684\u6838\u5fc3\u7d44\u6210\u90e8\u5206\uff0c\u5354\u52a9\u81e8\u5e8a\u91ab\u751f\u5728\u591a\u7a2e\u764c\u75c7\u985e\u578b\u4e2d\u5168\u9762\u89e3\u6790\u816b\u7624\u57fa\u56e0\u9ad4\u8b8a\u7570\u3002 \u7f8e\u570b FDA \u7684\u6838\u51c6\u904e\u7a0b\u65e2\u7e41\u8907\u4ea6\u56b4\u683c\uff0c\u6db5\u84cb\u5206\u6790\u3001\u81e8\u5e8a\u53ca\u8cc7\u8a0a\u79d1\u6280\u7b49\u9818\u57df\u3002 \u00a0 \u9019\u6b21\u6838\u51c6\u978f\u56fa\u4e86 DCG \u7684\u5730\u4f4d\uff0c\u4ee4\u516c\u53f8\u5f97\u4ee5\u5728\u81e8\u5e8a\u7ba1\u7406\u652f\u63f4\u3001\u8f49\u5316\u7814\u7a76\u8207\u751f\u7269\u6a19\u8a18\u958b\u767c\u7b49\u9818\u57df\uff0c\u8207\u570b\u969b\u81e8\u5e8a\u3001\u5b78\u8853\u53ca\u751f\u7269\u88fd\u85e5\u5925\u4f34\u65bc\u5171\u540c\u7684\u6cd5\u898f\u57fa\u790e\u4e0a\u5c55\u958b\u5408\u4f5c\u3002 \u5168\u7403\u7b56\u7565\u8207\u696d\u52d9\u62d3\u5c55\u9ad8\u7d1a\u7e3d\u76e3 Vineet Datta \u535a\u58eb\u8868\u793a\uff1a\u300cCellDx-Tissue \u6aa2\u6e2c\u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u70ba DCG \u6240\u63d0\u4f9b\u7684\u91cd\u8981\u89e3\u6c7a\u65b9\u6848\u589e\u6dfb\u4e86\u300c\u9ec3\u91d1\u6a19\u6e96\u300d\u7d1a\u5225\u7684\u76e3\u7ba1\u8a8d\u53ef\u3002 CellDx-Tissue \u5f4c\u88dc\u4e86\u57fa\u56e0\u9ad4\u8907\u96dc\u6027\u8207\u81e8\u5e8a\u6c7a\u7b56\u4e4b\u9593\u7684\u7f3a\u53e3\uff0c\u5728\u6cbb\u7642\u65b9\u6cd5\u8fc5\u901f\u6f14\u8b8a\u7684\u6642\u4ee3\u4e2d\uff0c\u70ba\u60a3\u8005\u63d0\u4f9b\u4e86\u66f4\u5ee3\u6cdb\u7684\u9078\u64c7\u3002 \u80fd\u5c07\u9019\u9805\u6280\u8853\u5e36\u7d66\u5168\u7403\u7684\u816b\u7624\u79d1\u91ab\u751f\uff0c\u4ee4\u6211\u5011\u611f\u5230\u76f8\u7576\u81ea\u8c6a\u3002\u300d \u96c6\u5718\u91ab\u7642\u4e8b\u52d9\u9ad8\u7d1a\u7e3d\u76e3 Darshana Patil \u535a\u58eb\u5247\u8868\u793a\uff1a\u300c\u6211\u5011\u4ee5\u7d44\u7e54\u70ba\u57fa\u790e\u7684\u57fa\u56e0\u9ad4\u6aa2\u6e2c\u65b9\u6848\u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u662f\u5c0d\u672c\u516c\u53f8\u79d1\u5b78\u6280\u8853\u548c\u54c1\u8cea\u7cfb\u7d71\u7684\u5be6\u8cea\u9a57\u8b49\u3002 \u6b64\u8209\u4ee4\u6211\u5011\u5f97\u4ee5\u70ba\u816b\u7624\u79d1\u91ab\u751f\u63d0\u4f9b\u53ef\u9760\u3001\u6a19\u6e96\u5316\u7684\u57fa\u56e0\u9ad4\u8cc7\u8a0a\uff0c\u70ba\u8907\u96dc\u7684\u6cbb\u7642\u6c7a\u7b56\u63d0\u4f9b\u6307\u5f15\uff0c\u4e26\u4e14\u978f\u56fa\u4e86\u6211\u5011\u7684\u627f\u8afe\uff0c\u5c31\u662f\u8981\u7d50\u5408\u5148\u9032\u57fa\u56e0\u9ad4\u6280\u8853\u3001\u56b4\u8b39\u79d1\u5b78\u65b9\u6cd5\u8207\u81e8\u5e8a\u5be6\u52d9\u50f9\u503c\u4f86\u670d\u52d9\u764c\u75c7\u75c5\u60a3\u8005\u3002\u300d \u7814\u767c\u8207\u5275\u65b0\u7e3d\u76e3 Dadasaheb Akolkar \u535a\u58eb\u88dc\u5145\u9053\uff1a\u300c\u9019\u6b21\u7372\u5f97\u6838\u51c6\uff0c\u5145\u5206\u9ad4\u73fe\u4e86\u6211\u5011\u7684\u79d1\u5b78\u8207\u54c1\u8cea\u5718\u968a\u5728 CellDx-Tissue \u5e73\u53f0\u958b\u767c\u904e\u7a0b\u4e2d\u6240\u5c55\u73fe\u51fa\u7684\u4e00\u81f4\u6027\u3001\u56b4\u8b39\u6027\u53ca\u4ee5\u81e8\u5e8a\u70ba\u5c0e\u5411\u7684\u8a2d\u8a08\u7406\u5ff5\u3002 \u6211\u5011\u71b1\u5207\u671f\u5f85\u5c07\u9019\u9805\u8b8a\u9769\u6027\u7684\u7cbe\u6e96\u816b\u7624\u91ab\u5b78\u89e3\u6c7a\u65b9\u6848\u63a8\u5ee3\u81f3\u5168\u7403\u5e02\u5834\uff0c\u8b93\u66f4\u591a\u764c\u75c7\u75c5\u60a3\u8005\u53d7\u60e0\u3002\u300d \u95dc\u65bc Datar Cancer Genetics Datar Cancer Genetics (DCG) \u662f\u4e00\u9593\u5168\u7403\u6027\u3001\u7531\u4eba\u5de5\u667a\u80fd\u9a45\u52d5\u7684\u7cbe\u6e96\u816b\u7624\u91ab\u5b78\u516c\u53f8\uff0c\u5c08\u6ce8\u65bc\u958b\u767c\u53ca\u63d0\u4f9b\u5148\u9032\u7684\u764c\u75c7\u8a3a\u65b7\u6280\u8853\uff0c\u5305\u62ec\u7528\u65bc\u65e9\u671f\u6aa2\u6e2c\u3001\u6cbb\u7642\u9078\u64c7\u548c\u764c\u75c7\u76e3\u6e2c\u7684\u975e\u4fb5\u5165\u6027\u6db2\u614b\u5207\u7247\u53ca\u4ee5\u7d44\u7e54\u70ba\u57fa\u790e\u7684\u591a\u9ad4\u5b78\u89e3\u6c7a\u65b9\u6848\u3002 DCG \u64c1\u6709\u7372\u5f97 UKAS\u3001CAP \u53ca CLIA \u8a8d\u8b49\u7684\u5be6\u9a57\u5ba4\uff0c\u696d\u52d9\u8db3\u8de1\u904d\u53ca\u82f1\u570b\u3001\u6b50\u76df\u3001\u7f8e\u570b\u3001\u6d77\u7063\u5408\u4f5c\u59d4\u54e1\u6703\u570b\u5bb6\u548c\u4e9e\u6d32\u3002 DCG \u8207\u5168\u7403\u81e8\u5e8a\u91ab\u751f\u53ca\u764c\u75c7\u4e2d\u5fc3\u5408\u4f5c\uff0c\u70ba\u5be6\u9ad4\u5668\u5b98\u764c\u75c7\u60a3\u8005\u63d0\u4f9b\u500b\u4eba\u5c08\u5c6c\u7684\u764c\u75c7\u8b77\u7406\u3002 \u7db2\u9801\uff1ahttps:\/\/datarpgx.com\/celldx-tissue","breadcrumb":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=436020#breadcrumb"},"inLanguage":"zh-TW","potentialAction":[{"@type":"ReadAction","target":["https:\/\/pingtungtimes.com.tw\/?p=436020"]}]},{"@type":"ImageObject","inLanguage":"zh-TW","@id":"https:\/\/pingtungtimes.com.tw\/?p=436020#primaryimage","url":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2026\/05\/Datar_Cancer_Genetics_US_FDA.jpg","contentUrl":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2026\/05\/Datar_Cancer_Genetics_US_FDA.jpg","width":400,"height":400},{"@type":"BreadcrumbList","@id":"https:\/\/pingtungtimes.com.tw\/?p=436020#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"\u9996\u9801","item":"https:\/\/pingtungtimes.com.tw\/"},{"@type":"ListItem","position":2,"name":"Datar Cancer Genetics \u7684 CellDx-Tissue \u7372\u5f97\u7f8e\u570b FDA \u6838\u51c6\uff0c\u70ba\u8a72\u9805\u5229\u7528 DNA \u8207 RNA \u9032\u884c\u7684\u5be6\u9ad4\u816b\u7624\u5168\u65b9\u4f4d\u57fa\u56e0\u9ad4\u5206\u6790\u6aa2\u6e2c\u5beb\u4e0b\u91cc\u7a0b\u7891"}]},{"@type":"WebSite","@id":"https:\/\/pingtungtimes.com.tw\/#website","url":"https:\/\/pingtungtimes.com.tw\/","name":"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","description":"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831PingtungTimes\uff0c\u6700\u95dc\u5fc3\u5728\u5730\u7684\u5a92\u9ad4","publisher":{"@id":"https:\/\/pingtungtimes.com.tw\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/pingtungtimes.com.tw\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"zh-TW"},{"@type":"Organization","@id":"https:\/\/pingtungtimes.com.tw\/#organization","name":"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","url":"https:\/\/pingtungtimes.com.tw\/","logo":{"@type":"ImageObject","inLanguage":"zh-TW","@id":"https:\/\/pingtungtimes.com.tw\/#\/schema\/logo\/image\/","url":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2023\/02\/logo-150.png","contentUrl":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2023\/02\/logo-150.png","width":150,"height":150,"caption":"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831"},"image":{"@id":"https:\/\/pingtungtimes.com.tw\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/pingtungnews"]},{"@type":"Person","@id":"https:\/\/pingtungtimes.com.tw\/#\/schema\/person\/683b937f29ec1537972f6c41e22a2cf3","name":"\u7f8e\u901a\u793e","image":{"@type":"ImageObject","inLanguage":"zh-TW","@id":"https:\/\/secure.gravatar.com\/avatar\/6c21e24ce33ca5d4572e343395adac2bbef44ff7035a74ea2cab2443c7f0a5f3?s=96&d=blank&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/6c21e24ce33ca5d4572e343395adac2bbef44ff7035a74ea2cab2443c7f0a5f3?s=96&d=blank&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/6c21e24ce33ca5d4572e343395adac2bbef44ff7035a74ea2cab2443c7f0a5f3?s=96&d=blank&r=g","caption":"\u7f8e\u901a\u793e"},"url":"https:\/\/pingtungtimes.com.tw\/?author=16"}]}},"_links":{"self":[{"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=\/wp\/v2\/posts\/436020","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=\/wp\/v2\/users\/16"}],"replies":[{"embeddable":true,"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=436020"}],"version-history":[{"count":0,"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=\/wp\/v2\/posts\/436020\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=\/wp\/v2\/media\/436021"}],"wp:attachment":[{"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=436020"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=436020"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=436020"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}