{"id":315182,"date":"2025-04-21T19:31:00","date_gmt":"2025-04-21T11:31:00","guid":{"rendered":"https:\/\/pingtungtimes.com.tw\/?p=315182"},"modified":"2025-04-21T19:31:00","modified_gmt":"2025-04-21T11:31:00","slug":"%e4%ba%9e%e6%b4%b2%e9%a6%96%e5%80%8bctdna-mrd%e7%9c%9f%e5%af%a6%e4%b8%96%e7%95%8c%e7%a0%94%e7%a9%b6%e6%88%90%e6%9e%9c%e7%99%bc%e5%b8%83%ef%bc%8c%e7%82%ba%e9%ab%98%e6%80%a7%e5%83%b9%e6%af%94%e7%99%8c","status":"publish","type":"post","link":"https:\/\/pingtungtimes.com.tw\/?p=315182","title":{"rendered":"\u4e9e\u6d32\u9996\u500bctDNA-MRD\u771f\u5be6\u4e16\u754c\u7814\u7a76\u6210\u679c\u767c\u5e03\uff0c\u70ba\u9ad8\u6027\u50f9\u6bd4\u764c\u75c7\u76e3\u6e2c\u63d0\u4f9b\u6709\u529b\u8b49\u64da"},"content":{"rendered":"
\n

\u4e00\u9805\u65bc<\/i> 2025 \u5e74 3 \u6708\u65b0\u8fd1\u767c\u8868\u65bc\u300aJCO Oncology Advances\u300b\u7684\u88e1\u7a0b\u7891\u5f0f\u7814\u7a76\uff0c\u7d0d\u5165623\u540d\u5be6\u9ad4\u7624\uff08\u5305\u62ec\u4e73\u817a\u764c\u3001\u7d50\u76f4\u8178\u764c\u3001\u80ba\u764c\u3001\u80c3\u764c\u3001\u809d\u764c\u548c\u5375\u5de2\u764c\u5171\u516d\u7a2e\u764c\u75c7\u985e\u5225\uff09\u60a3\u8005\uff0c\u5c55\u793a\u4e86
\u5716 1. ctDNA \u5206\u6790\u5de5\u4f5c\u6d41\u7a0b\u3002\u5c0d\u65bc\u65e9\u671f I-III \u671f\u60a3\u8005\uff0c\u5c0d\u914d\u5c0d\u7684\u816b\u7624 FFPE \u548c WBC DNA \u6a23\u672c\u9032\u884c\u6e2c\u5e8f\uff0c\u4ee5\u8b58\u5225 155 \u500b\u764c\u75c7\u76f8\u95dc\u57fa\u56e0\u4e2d\u7684\u816b\u7624\u7279\u7570\u6027\u7a81\u8b8a\u3002\u5229\u7528\u6392\u5e8f\u5f97\u5206\u6700\u9ad8\u7684\u500b\u6027\u5316\u7a81\u8b8a\uff0c\u901a\u904e mPCR \u548c\u8d85\u6df1\u5ea6\u6e2c\u5e8f\u6aa2\u6e2c\u8840\u6f3f\u6a23\u672c\u4e2d\u7684 ctDNA\u3002\u5c0d\u65bc\u8f49\u79fb\u6027 IV \u671f\u60a3\u8005\uff0c\u9664\u4e86\u500b\u6027\u5316\u7a81\u8b8a\u5916\uff0c\u9084\u984d\u5916\u6dfb\u52a0\u4e86\u7d04 500 \u500b\u91dd\u5c0d\u6bcf\u7a2e\u764c\u75c7\u985e\u578b\u7279\u7570\u6027\u7684\u71b1\u9ede\u7a81\u8b8a\u7d44\u9032\u884c\u5206\u6790\u3002<\/span><\/p>\n<\/p><\/div>\n

ctDNA \u7684\u5be6\u6642\u76e3\u6e2c\u5df2\u88ab\u8b49\u660e\u53ef\u6709\u6548\u9810\u6e2c\u65e9\u671f\u764c\u75c7\u5fa9\u767c\uff0c\u5f9e\u800c\u53ca\u6642\u5e72\u9810\u4e26\u6539\u5584\u60a3\u8005\u9810\u5f8c\u3002\u7121\u8ad6\u662f\u65e9\u671f\u9084\u662f\u665a\u671f\u764c\u75c7\u60a3\u8005\uff0cK-TRACKTM<\/sup> \u90fd\u5c55\u73fe\u51fa\u6975\u9ad8\u7684\u5fa9\u767c\u9810\u6e2c\u51c6\u78ba\u6027\u3002\u8853\u5f8c 84.4%<\/b> \u7684 ctDNA \u6aa2\u6e2c\u7d50\u679c\u5448\u967d\u6027\u7684\u60a3\u8005\u6700\u7d42\u5fa9\u767c\uff0c\u800c ctDNA \u6aa2\u6e2c\u7d50\u679c\u5448\u9670\u6027\u7684\u60a3\u8005\u4e2d\uff0c\u9ad8\u9054 96.3%<\/b> \u7684\u60a3\u8005\u4ecd\u4fdd\u6301\u7121\u764c\u72c0\u614b\u3002\u6b64\u5916\uff0c\u8a72\u6aa2\u6e2c\u53ef\u6bd4\u5f71\u50cf\u5b78\u6aa2\u67e5\u7684\u81e8\u5e8a\u8a3a\u65b7\u63d0\u524d 5.5 \u81f3 19.5 \u500b\u6708\u767c\u73fe\u5fa9\u767c\u3002\u540c\u6642\uff0c6 \u500b\u6848\u4f8b\u7814\u7a76\u5c55\u793a\u4e86 ctDNA \u76e3\u6e2c\u5728\u9810\u6e2c\u6cbb\u7642\u53cd\u61c9\u3001\u6307\u5c0e\u8f14\u52a9\u5316\u7642\u6c7a\u7b56\u4ee5\u53ca\u8b58\u5225\u7576\u524d\u9776\u5411\u6cbb\u7642\u7684\u65b0\u8010\u85e5\u7a81\u8b8a\u65b9\u9762\u7684\u81e8\u5e8a\u61c9\u7528\u3002\u5f9e\u800c\u70ba\u81e8\u5e8a\u91ab\u751f\u63d0\u4f9b\u5be6\u6642\u3001\u53ef\u64cd\u4f5c\u7684\u6d1e\u5bdf\uff0c\u70ba\u6cbb\u7642\u6c7a\u7b56\u63d0\u4f9b\u53c3\u8003\u3002<\/p>\n

\n

\"\u5716<\/a>
\u5716 2. ctDNA \u5728\u65e9\u671f\u764c\u75c7\u4e2d\u7684\u9810\u5f8c\u50f9\u503c\u3002(A-D) \u6839\u64da\u8853\u5f8c ctDNA \u72c0\u614b\u5206\u5c64\u7684\u60a3\u8005\uff0c\u5c0d\u7121\u75c5\u751f\u5b58\u671f Disease-free survival (DFS) \u9032\u884c Kaplan-Meier \u5206\u6790\u3002(E) \u5c0d\u65bc\u7591\u4f3c\u5fa9\u767c\u7684\u60a3\u8005\uff0cctDNA \u7d50\u679c\u8207\u5f8c\u7e8c\u8a3a\u65b7\u7684\u4e00\u81f4\u6027\u70ba 87.0%\u3002(F) \u5728\u7591\u4f3c\u548c\u5e38\u898f\u76e3\u6e2c\u75c5\u4f8b\u4e2d\uff0cctDNA \u7684 Variant allele frequency (VAF) \u8207\u5fa9\u767c\u6642\u9593\u5747\u7121\u76f8\u95dc\u6027\u3002<\/span><\/p>\n<\/p><\/div>\n

\u516c\u5e73\u53ef\u53ca\u7684\u91ab\u7642\u9858\u666f<\/b><\/p>\n

Gene Solutions \u9996\u5e2d\u7814\u7a76\u54e1 Dr. Lan N. Tu<\/span> \u8868\u793a\uff1a\u300c\u57fa\u65bc\u816b\u7624\u57fa\u56e0\u5716\u8b5c\u5206\u6790\u7684\u5c16\u7aef\u3001\u500b\u6027\u5316\u764c\u75c7\u6cbb\u7642\u548c\u76e3\u6e2c\u7684\u53ef\u53ca\u6027\uff0c\u5f80\u5f80\u53d6\u6c7a\u65bc\u60a3\u8005\u5c45\u4f4f\u5730\u6216\u7d93\u6fdf\u627f\u53d7\u80fd\u529b\u3002\u6211\u5011\u958b\u767c K-TRACK\u2122 \u7684\u4f7f\u547d\u6b63\u662f\u70ba\u4e86\u5f4c\u5408\u9019\u4e00\u5dee\u8ddd\uff0c\u63d0\u4f9b\u4e00\u7a2e\u50f9\u683c\u5408\u7406\u3001\u7cbe\u51c6\u4e14\u53ef\u7528\u65bc\u5e38\u898f\u81e8\u5e8a\u5be6\u8e10\u7684\u5be6\u6642\u89e3\u6c7a\u65b9\u6848\u3002\u300d<\/b><\/p>\n

Gene Solutions \u6b63\u7a4d\u6975\u6295\u5165\u5169\u5927\u95dc\u9375\u7814\u7a76\u65b9\u5411\uff1a<\/p>\n

1.<\/b>\u6301\u7e8c\u9032\u884c\u7684\u81e8\u5e8a\u8a66\u9a57\u548c\u771f\u5be6\u4e16\u754c\u7814\u7a76<\/p>\n

\u516c\u53f8\u6b63\u5728\u9032\u884c\u5168\u9762\u7684\u7814\u7a76\uff0c\u4ee5\u9a57\u8b49 ctDNA \u5728\u5404\u7a2e\u764c\u75c7\u985e\u578b\u548c\u6cbb\u7642\u968e\u6bb5\u7684\u4f5c\u7528\u3002\u9019\u5305\u62ec\u8a55\u4f30\u80ba\u764c\u4e2d\u5c0d TKI \u548c\u514d\u75ab\u6aa2\u67e5\u9ede\u6291\u5236\u5291\uff08ICIs\uff09\u7684\u53cd\u61c9\u3001\u4e73\u817a\u764c\u7684\u65b0\u8f14\u52a9\u6cbb\u7642\u3001\u76f4\u8178\u764c\u7684\u5168\u7a0b\u65b0\u8f14\u52a9\u6cbb\u7642\uff0c\u4ee5\u53ca\u5229\u7528\u751f\u7269\u6a19\u5fd7\u7269\u6307\u5c0e\u665a\u671f\u764c\u75c7\u514d\u75ab\u6cbb\u7642\u6c7a\u7b56\u7b49\u3002<\/p>\n

2.<\/b>\u751f\u7269\u5236\u85e5\u5408\u4f5c<\/p>\n

Gene Solutions \u6b63\u7a4d\u6975\u5c0b\u6c42\u8207\u751f\u7269\u5236\u85e5\u516c\u53f8\u5408\u4f5c\uff0c\u63d0\u4f9b\u5275\u65b0\u89e3\u6c7a\u65b9\u6848\uff0c\u65e8\u5728\u52a0\u901f\u5404\u7a2e\u6cbb\u7642\u6a21\u5f0f\u7684\u85e5\u7269\u958b\u767c\u3002\u96a8\u8457\u652f\u6301 ctDNA \u7684\u79d1\u5b78\u8b49\u64da\u4e0d\u65b7\u589e\u591a\uff0cGene Solutions \u81f4\u529b\u65bc\u62d3\u5c55\u7814\u7a76\uff0c\u4e26\u8207\u73fe\u6709\u53ca\u65b0\u5408\u4f5c\u4f19\u4f34\u5efa\u7acb\u5408\u4f5c\u95dc\u7cfb\uff0c\u63a2\u7d22\u5176\u5728\u764c\u75c7\u6cbb\u7642\u9818\u57df\u7684\u65b0\u61c9\u7528\u3002\u516c\u53f8\u7684\u767c\u5c55\u65b9\u5411\u8207 FDA \u95dc\u65bc\u5c07 ctDNA \u7528\u4f5c\u751f\u7269\u6a19\u8a18\u7269\uff0c\u7528\u65bc\u958b\u767c\u5be6\u9ad4\u816b\u7624\u6cbb\u6108\u6027\u7642\u6cd5\u7684\u5efa\u8b70\u76f8\u4e00\u81f4\uff0c\u8a72\u5efa\u8b70\u6307\u51fa\uff1a\u300cctDNA \u4f5c\u70ba\u751f\u7269\u6a19\u8a18\u7269\uff0c\u5728\u65e9\u671f\u968e\u6bb5\u5177\u6709\u591a\u7a2e\u6f5b\u5728\u7684\u76e3\u7ba1\u548c\u81e8\u5e8a\u7528\u9014\uff0c\u53ef\u80fd\u6709\u52a9\u65bc\u4e26\u52a0\u901f\u85e5\u7269\u958b\u767c\u3002\u300d(5)<\/sub><\/p>\n

\u95dc\u65bc Gene Solutions<\/b><\/p>\n

Gene Solutions \u662f\u4e00\u5bb6\u4e9e\u6d32\u8de8\u570b\u751f\u7269\u79d1\u6280\u516c\u53f8\uff0c\u5728\u5229\u7528\u5148\u9032\u7684\u4eba\u5de5\u667a\u80fd (AI) \u548c ctDNA \u6280\u8853\u63d0\u4f9b\u5275\u65b0\u764c\u75c7\u6aa2\u6e2c\u89e3\u6c7a\u65b9\u6848\u65b9\u9762\u8655\u65bc\u9818\u5148\u5730\u4f4d\u3002\u516c\u53f8\u8207\u6771\u5357\u4e9e 4,500 \u591a\u5bb6\u91ab\u9662\u548c\u8a3a\u6240\u5408\u4f5c\uff0c\u64c1\u6709\u4e00\u652f\u7531\u7d04 250 \u540d\u751f\u7269\u5b78\u5c08\u5bb6\u548c\u6280\u8853\u4eba\u54e1\u7d44\u6210\u7684\u5c08\u696d\u5718\u968a\uff0c\u54e1\u5de5\u7e3d\u6578\u9054 700 \u4eba\u3002<\/p>\n

Gene Solutions \u5df2\u5728\u6771\u5357\u4e9e\u5730\u5340\u767c\u8868\u4e86 50 \u591a\u7bc7\u540c\u884c\u8a55\u5be9\u7684\u8ad6\u6587\uff0c\u4e26\u958b\u5c55\u4e86 50 \u591a\u9805\u591a\u4e2d\u5fc3\u7814\u7a76\uff0c\u5176\u81ea\u4e3b\u7814\u767c\u6210\u679c\u4ee5\u53ca\u4f4d\u65bc\u65b0\u52a0\u5761\u548c\u8d8a\u5357\u7684 CAP \u8a8d\u8b49\u7684\u65b0\u4e00\u4ee3\u6e2c\u5e8f (NGS) \u5be6\u9a57\u5ba4\u5099\u53d7\u8a8d\u53ef\u3002\u901a\u904e\u5c07\u591a\u7dad\u57fa\u56e0\u7d44\u5b78\u8207\u4eba\u5de5\u667a\u80fd\u9a45\u52d5\u7684\u65b9\u6cd5\u76f8\u7d50\u5408\uff0c\u516c\u53f8\u81f4\u529b\u65bc\u8b8a\u9769\u764c\u75c7\u6cbb\u7642\uff0c\u4ee4\u66f4\u591a\u764c\u75c7\u60a3\u8005\u53d7\u76ca\u3002<\/p>\n

    \n
  1. Hoang, V.-A.N. et al. (2025) ‘Real-World utilization and performance of circulating tumor DNA monitoring to predict recurrence in solid tumors,’ JCO Oncology Advances, Volume 2. DOI: 10.1200\/OA-24-00084<\/span><\/li>\n
  2. Huang, J. et al. (2022) ‘Cancer incidence and mortality in Asian countries: a trend analysis,’ Cancer Control, 29. DOI:10.1177\/10732748221095955.<\/span><\/li>\n
  3. Sharma, R. et al. (2024) ‘Temporal patterns of cancer burden in Asia<\/span>, 1990-2019: a systematic examination for the Global Burden of Disease 2019 study,’ The Lancet Regional Health – Southeast Asia<\/span>, 21, p. 100333. DOI:10.1016\/j.lansea.2023.100333.<\/span><\/li>\n
  4. Kobayashi, S. et al. (2025) ‘Japan<\/span> society of clinical oncology position paper on appropriate clinical use of molecular residual disease (MRD) testing,’ International Journal of Clinical Oncology [Preprint]. DOI:10.1007\/s10147-024-02683-0.<\/span><\/li>\n
  5. Use of Circulating Tumor DNA for Curative-Intent Solid Tumor Drug Development. (2024). In Guidance for Industry [Clinical\/Medical]. FDA Guidances, Content current as of: 01\/17\/2025.<\/span><\/li>\n<\/ol>\n
    <\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

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Tu \u8868\u793a\uff1a\u300c\u57fa\u65bc\u816b\u7624\u57fa\u56e0\u5716\u8b5c\u5206\u6790\u7684\u5c16\u7aef\u3001\u500b\u6027\u5316\u764c\u75c7\u6cbb\u7642\u548c\u76e3\u6e2c\u7684\u53ef\u53ca\u6027\uff0c\u5f80\u5f80\u53d6\u6c7a\u65bc\u60a3\u8005\u5c45\u4f4f\u5730\u6216\u7d93\u6fdf\u627f\u53d7\u80fd\u529b\u3002\u6211\u5011\u958b\u767c K-TRACK\u2122 \u7684\u4f7f\u547d\u6b63\u662f\u70ba\u4e86\u5f4c\u5408\u9019\u4e00\u5dee\u8ddd\uff0c\u63d0\u4f9b\u4e00\u7a2e\u50f9\u683c\u5408\u7406\u3001\u7cbe\u51c6\u4e14\u53ef\u7528\u65bc\u5e38\u898f\u81e8\u5e8a\u5be6\u8e10\u7684\u5be6\u6642\u89e3\u6c7a\u65b9\u6848\u3002\u300d Gene Solutions \u6b63\u7a4d\u6975\u6295\u5165\u5169\u5927\u95dc\u9375\u7814\u7a76\u65b9\u5411\uff1a 1.\u6301\u7e8c\u9032\u884c\u7684\u81e8\u5e8a\u8a66\u9a57\u548c\u771f\u5be6\u4e16\u754c\u7814\u7a76 \u516c\u53f8\u6b63\u5728\u9032\u884c\u5168\u9762\u7684\u7814\u7a76\uff0c\u4ee5\u9a57\u8b49 ctDNA \u5728\u5404\u7a2e\u764c\u75c7\u985e\u578b\u548c\u6cbb\u7642\u968e\u6bb5\u7684\u4f5c\u7528\u3002\u9019\u5305\u62ec\u8a55\u4f30\u80ba\u764c\u4e2d\u5c0d TKI \u548c\u514d\u75ab\u6aa2\u67e5\u9ede\u6291\u5236\u5291\uff08ICIs\uff09\u7684\u53cd\u61c9\u3001\u4e73\u817a\u764c\u7684\u65b0\u8f14\u52a9\u6cbb\u7642\u3001\u76f4\u8178\u764c\u7684\u5168\u7a0b\u65b0\u8f14\u52a9\u6cbb\u7642\uff0c\u4ee5\u53ca\u5229\u7528\u751f\u7269\u6a19\u5fd7\u7269\u6307\u5c0e\u665a\u671f\u764c\u75c7\u514d\u75ab\u6cbb\u7642\u6c7a\u7b56\u7b49\u3002 2.\u751f\u7269\u5236\u85e5\u5408\u4f5c Gene Solutions \u6b63\u7a4d\u6975\u5c0b\u6c42\u8207\u751f\u7269\u5236\u85e5\u516c\u53f8\u5408\u4f5c\uff0c\u63d0\u4f9b\u5275\u65b0\u89e3\u6c7a\u65b9\u6848\uff0c\u65e8\u5728\u52a0\u901f\u5404\u7a2e\u6cbb\u7642\u6a21\u5f0f\u7684\u85e5\u7269\u958b\u767c\u3002\u96a8\u8457\u652f\u6301 ctDNA \u7684\u79d1\u5b78\u8b49\u64da\u4e0d\u65b7\u589e\u591a\uff0cGene Solutions \u81f4\u529b\u65bc\u62d3\u5c55\u7814\u7a76\uff0c\u4e26\u8207\u73fe\u6709\u53ca\u65b0\u5408\u4f5c\u4f19\u4f34\u5efa\u7acb\u5408\u4f5c\u95dc\u7cfb\uff0c\u63a2\u7d22\u5176\u5728\u764c\u75c7\u6cbb\u7642\u9818\u57df\u7684\u65b0\u61c9\u7528\u3002\u516c\u53f8\u7684\u767c\u5c55\u65b9\u5411\u8207 FDA \u95dc\u65bc\u5c07 ctDNA \u7528\u4f5c\u751f\u7269\u6a19\u8a18\u7269\uff0c\u7528\u65bc\u958b\u767c\u5be6\u9ad4\u816b\u7624\u6cbb\u6108\u6027\u7642\u6cd5\u7684\u5efa\u8b70\u76f8\u4e00\u81f4\uff0c\u8a72\u5efa\u8b70\u6307\u51fa\uff1a\u300cctDNA \u4f5c\u70ba\u751f\u7269\u6a19\u8a18\u7269\uff0c\u5728\u65e9\u671f\u968e\u6bb5\u5177\u6709\u591a\u7a2e\u6f5b\u5728\u7684\u76e3\u7ba1\u548c\u81e8\u5e8a\u7528\u9014\uff0c\u53ef\u80fd\u6709\u52a9\u65bc\u4e26\u52a0\u901f\u85e5\u7269\u958b\u767c\u3002\u300d(5) \u95dc\u65bc Gene Solutions Gene Solutions \u662f\u4e00\u5bb6\u4e9e\u6d32\u8de8\u570b\u751f\u7269\u79d1\u6280\u516c\u53f8\uff0c\u5728\u5229\u7528\u5148\u9032\u7684\u4eba\u5de5\u667a\u80fd (AI) \u548c ctDNA \u6280\u8853\u63d0\u4f9b\u5275\u65b0\u764c\u75c7\u6aa2\u6e2c\u89e3\u6c7a\u65b9\u6848\u65b9\u9762\u8655\u65bc\u9818\u5148\u5730\u4f4d\u3002\u516c\u53f8\u8207\u6771\u5357\u4e9e 4,500 \u591a\u5bb6\u91ab\u9662\u548c\u8a3a\u6240\u5408\u4f5c\uff0c\u64c1\u6709\u4e00\u652f\u7531\u7d04 250 \u540d\u751f\u7269\u5b78\u5c08\u5bb6\u548c\u6280\u8853\u4eba\u54e1\u7d44\u6210\u7684\u5c08\u696d\u5718\u968a\uff0c\u54e1\u5de5\u7e3d\u6578\u9054 700 \u4eba\u3002 Gene Solutions \u5df2\u5728\u6771\u5357\u4e9e\u5730\u5340\u767c\u8868\u4e86 50 \u591a\u7bc7\u540c\u884c\u8a55\u5be9\u7684\u8ad6\u6587\uff0c\u4e26\u958b\u5c55\u4e86 50 \u591a\u9805\u591a\u4e2d\u5fc3\u7814\u7a76\uff0c\u5176\u81ea\u4e3b\u7814\u767c\u6210\u679c\u4ee5\u53ca\u4f4d\u65bc\u65b0\u52a0\u5761\u548c\u8d8a\u5357\u7684 CAP \u8a8d\u8b49\u7684\u65b0\u4e00\u4ee3\u6e2c\u5e8f (NGS) \u5be6\u9a57\u5ba4\u5099\u53d7\u8a8d\u53ef\u3002\u901a\u904e\u5c07\u591a\u7dad\u57fa\u56e0\u7d44\u5b78\u8207\u4eba\u5de5\u667a\u80fd\u9a45\u52d5\u7684\u65b9\u6cd5\u76f8\u7d50\u5408\uff0c\u516c\u53f8\u81f4\u529b\u65bc\u8b8a\u9769\u764c\u75c7\u6cbb\u7642\uff0c\u4ee4\u66f4\u591a\u764c\u75c7\u60a3\u8005\u53d7\u76ca\u3002 Hoang, V.-A.N. et al. (2025) 'Real-World utilization and performance of circulating tumor DNA monitoring to predict recurrence in solid tumors,' JCO Oncology Advances, Volume 2. DOI: 10.1200\/OA-24-00084 Huang, J. et al. (2022) 'Cancer incidence and mortality in Asian countries: a trend analysis,' Cancer Control, 29. DOI:10.1177\/10732748221095955. Sharma, R. et al. (2024) 'Temporal patterns of cancer burden in Asia, 1990-2019: a systematic examination for the Global Burden of Disease 2019 study,' The Lancet Regional Health - Southeast Asia, 21, p. 100333. DOI:10.1016\/j.lansea.2023.100333. Kobayashi, S. et al. (2025) 'Japan society of clinical oncology position paper on appropriate clinical use of molecular residual disease (MRD) testing,' International Journal of Clinical Oncology . DOI:10.1007\/s10147-024-02683-0. Use of Circulating Tumor DNA for Curative-Intent Solid Tumor Drug Development. (2024). In Guidance for Industry . FDA Guidances, Content current as of: 01\/17\/2025.\" \/>\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=315182\" \/>\n<meta property=\"og:locale\" content=\"zh_TW\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u4e9e\u6d32\u9996\u500bctDNA-MRD\u771f\u5be6\u4e16\u754c\u7814\u7a76\u6210\u679c\u767c\u5e03\uff0c\u70ba\u9ad8\u6027\u50f9\u6bd4\u764c\u75c7\u76e3\u6e2c\u63d0\u4f9b\u6709\u529b\u8b49\u64da - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\" \/>\n<meta property=\"og:description\" content=\"\u4e00\u9805\u65bc 2025 \u5e74 3 \u6708\u65b0\u8fd1\u767c\u8868\u65bc\u300aJCO Oncology Advances\u300b\u7684\u88e1\u7a0b\u7891\u5f0f\u7814\u7a76\uff0c\u7d0d\u5165623\u540d\u5be6\u9ad4\u7624\uff08\u5305\u62ec\u4e73\u817a\u764c\u3001\u7d50\u76f4\u8178\u764c\u3001\u80ba\u764c\u3001\u80c3\u764c\u3001\u809d\u764c\u548c\u5375\u5de2\u764c\u5171\u516d\u7a2e\u764c\u75c7\u985e\u5225\uff09\u60a3\u8005\uff0c\u5c55\u793a\u4e86\u5716 1. ctDNA \u5206\u6790\u5de5\u4f5c\u6d41\u7a0b\u3002\u5c0d\u65bc\u65e9\u671f I-III \u671f\u60a3\u8005\uff0c\u5c0d\u914d\u5c0d\u7684\u816b\u7624 FFPE \u548c WBC DNA \u6a23\u672c\u9032\u884c\u6e2c\u5e8f\uff0c\u4ee5\u8b58\u5225 155 \u500b\u764c\u75c7\u76f8\u95dc\u57fa\u56e0\u4e2d\u7684\u816b\u7624\u7279\u7570\u6027\u7a81\u8b8a\u3002\u5229\u7528\u6392\u5e8f\u5f97\u5206\u6700\u9ad8\u7684\u500b\u6027\u5316\u7a81\u8b8a\uff0c\u901a\u904e mPCR \u548c\u8d85\u6df1\u5ea6\u6e2c\u5e8f\u6aa2\u6e2c\u8840\u6f3f\u6a23\u672c\u4e2d\u7684 ctDNA\u3002\u5c0d\u65bc\u8f49\u79fb\u6027 IV \u671f\u60a3\u8005\uff0c\u9664\u4e86\u500b\u6027\u5316\u7a81\u8b8a\u5916\uff0c\u9084\u984d\u5916\u6dfb\u52a0\u4e86\u7d04 500 \u500b\u91dd\u5c0d\u6bcf\u7a2e\u764c\u75c7\u985e\u578b\u7279\u7570\u6027\u7684\u71b1\u9ede\u7a81\u8b8a\u7d44\u9032\u884c\u5206\u6790\u3002 ctDNA \u7684\u5be6\u6642\u76e3\u6e2c\u5df2\u88ab\u8b49\u660e\u53ef\u6709\u6548\u9810\u6e2c\u65e9\u671f\u764c\u75c7\u5fa9\u767c\uff0c\u5f9e\u800c\u53ca\u6642\u5e72\u9810\u4e26\u6539\u5584\u60a3\u8005\u9810\u5f8c\u3002\u7121\u8ad6\u662f\u65e9\u671f\u9084\u662f\u665a\u671f\u764c\u75c7\u60a3\u8005\uff0cK-TRACKTM \u90fd\u5c55\u73fe\u51fa\u6975\u9ad8\u7684\u5fa9\u767c\u9810\u6e2c\u51c6\u78ba\u6027\u3002\u8853\u5f8c 84.4% \u7684 ctDNA \u6aa2\u6e2c\u7d50\u679c\u5448\u967d\u6027\u7684\u60a3\u8005\u6700\u7d42\u5fa9\u767c\uff0c\u800c ctDNA \u6aa2\u6e2c\u7d50\u679c\u5448\u9670\u6027\u7684\u60a3\u8005\u4e2d\uff0c\u9ad8\u9054 96.3% \u7684\u60a3\u8005\u4ecd\u4fdd\u6301\u7121\u764c\u72c0\u614b\u3002\u6b64\u5916\uff0c\u8a72\u6aa2\u6e2c\u53ef\u6bd4\u5f71\u50cf\u5b78\u6aa2\u67e5\u7684\u81e8\u5e8a\u8a3a\u65b7\u63d0\u524d 5.5 \u81f3 19.5 \u500b\u6708\u767c\u73fe\u5fa9\u767c\u3002\u540c\u6642\uff0c6 \u500b\u6848\u4f8b\u7814\u7a76\u5c55\u793a\u4e86 ctDNA \u76e3\u6e2c\u5728\u9810\u6e2c\u6cbb\u7642\u53cd\u61c9\u3001\u6307\u5c0e\u8f14\u52a9\u5316\u7642\u6c7a\u7b56\u4ee5\u53ca\u8b58\u5225\u7576\u524d\u9776\u5411\u6cbb\u7642\u7684\u65b0\u8010\u85e5\u7a81\u8b8a\u65b9\u9762\u7684\u81e8\u5e8a\u61c9\u7528\u3002\u5f9e\u800c\u70ba\u81e8\u5e8a\u91ab\u751f\u63d0\u4f9b\u5be6\u6642\u3001\u53ef\u64cd\u4f5c\u7684\u6d1e\u5bdf\uff0c\u70ba\u6cbb\u7642\u6c7a\u7b56\u63d0\u4f9b\u53c3\u8003\u3002 \u5716 2. ctDNA \u5728\u65e9\u671f\u764c\u75c7\u4e2d\u7684\u9810\u5f8c\u50f9\u503c\u3002(A-D) \u6839\u64da\u8853\u5f8c ctDNA \u72c0\u614b\u5206\u5c64\u7684\u60a3\u8005\uff0c\u5c0d\u7121\u75c5\u751f\u5b58\u671f Disease-free survival (DFS) \u9032\u884c Kaplan-Meier \u5206\u6790\u3002(E) \u5c0d\u65bc\u7591\u4f3c\u5fa9\u767c\u7684\u60a3\u8005\uff0cctDNA \u7d50\u679c\u8207\u5f8c\u7e8c\u8a3a\u65b7\u7684\u4e00\u81f4\u6027\u70ba 87.0%\u3002(F) \u5728\u7591\u4f3c\u548c\u5e38\u898f\u76e3\u6e2c\u75c5\u4f8b\u4e2d\uff0cctDNA \u7684 Variant allele frequency (VAF) \u8207\u5fa9\u767c\u6642\u9593\u5747\u7121\u76f8\u95dc\u6027\u3002 \u516c\u5e73\u53ef\u53ca\u7684\u91ab\u7642\u9858\u666f Gene Solutions \u9996\u5e2d\u7814\u7a76\u54e1 Dr. Lan N. Tu \u8868\u793a\uff1a\u300c\u57fa\u65bc\u816b\u7624\u57fa\u56e0\u5716\u8b5c\u5206\u6790\u7684\u5c16\u7aef\u3001\u500b\u6027\u5316\u764c\u75c7\u6cbb\u7642\u548c\u76e3\u6e2c\u7684\u53ef\u53ca\u6027\uff0c\u5f80\u5f80\u53d6\u6c7a\u65bc\u60a3\u8005\u5c45\u4f4f\u5730\u6216\u7d93\u6fdf\u627f\u53d7\u80fd\u529b\u3002\u6211\u5011\u958b\u767c K-TRACK\u2122 \u7684\u4f7f\u547d\u6b63\u662f\u70ba\u4e86\u5f4c\u5408\u9019\u4e00\u5dee\u8ddd\uff0c\u63d0\u4f9b\u4e00\u7a2e\u50f9\u683c\u5408\u7406\u3001\u7cbe\u51c6\u4e14\u53ef\u7528\u65bc\u5e38\u898f\u81e8\u5e8a\u5be6\u8e10\u7684\u5be6\u6642\u89e3\u6c7a\u65b9\u6848\u3002\u300d Gene Solutions \u6b63\u7a4d\u6975\u6295\u5165\u5169\u5927\u95dc\u9375\u7814\u7a76\u65b9\u5411\uff1a 1.\u6301\u7e8c\u9032\u884c\u7684\u81e8\u5e8a\u8a66\u9a57\u548c\u771f\u5be6\u4e16\u754c\u7814\u7a76 \u516c\u53f8\u6b63\u5728\u9032\u884c\u5168\u9762\u7684\u7814\u7a76\uff0c\u4ee5\u9a57\u8b49 ctDNA \u5728\u5404\u7a2e\u764c\u75c7\u985e\u578b\u548c\u6cbb\u7642\u968e\u6bb5\u7684\u4f5c\u7528\u3002\u9019\u5305\u62ec\u8a55\u4f30\u80ba\u764c\u4e2d\u5c0d TKI \u548c\u514d\u75ab\u6aa2\u67e5\u9ede\u6291\u5236\u5291\uff08ICIs\uff09\u7684\u53cd\u61c9\u3001\u4e73\u817a\u764c\u7684\u65b0\u8f14\u52a9\u6cbb\u7642\u3001\u76f4\u8178\u764c\u7684\u5168\u7a0b\u65b0\u8f14\u52a9\u6cbb\u7642\uff0c\u4ee5\u53ca\u5229\u7528\u751f\u7269\u6a19\u5fd7\u7269\u6307\u5c0e\u665a\u671f\u764c\u75c7\u514d\u75ab\u6cbb\u7642\u6c7a\u7b56\u7b49\u3002 2.\u751f\u7269\u5236\u85e5\u5408\u4f5c Gene Solutions \u6b63\u7a4d\u6975\u5c0b\u6c42\u8207\u751f\u7269\u5236\u85e5\u516c\u53f8\u5408\u4f5c\uff0c\u63d0\u4f9b\u5275\u65b0\u89e3\u6c7a\u65b9\u6848\uff0c\u65e8\u5728\u52a0\u901f\u5404\u7a2e\u6cbb\u7642\u6a21\u5f0f\u7684\u85e5\u7269\u958b\u767c\u3002\u96a8\u8457\u652f\u6301 ctDNA \u7684\u79d1\u5b78\u8b49\u64da\u4e0d\u65b7\u589e\u591a\uff0cGene Solutions \u81f4\u529b\u65bc\u62d3\u5c55\u7814\u7a76\uff0c\u4e26\u8207\u73fe\u6709\u53ca\u65b0\u5408\u4f5c\u4f19\u4f34\u5efa\u7acb\u5408\u4f5c\u95dc\u7cfb\uff0c\u63a2\u7d22\u5176\u5728\u764c\u75c7\u6cbb\u7642\u9818\u57df\u7684\u65b0\u61c9\u7528\u3002\u516c\u53f8\u7684\u767c\u5c55\u65b9\u5411\u8207 FDA \u95dc\u65bc\u5c07 ctDNA \u7528\u4f5c\u751f\u7269\u6a19\u8a18\u7269\uff0c\u7528\u65bc\u958b\u767c\u5be6\u9ad4\u816b\u7624\u6cbb\u6108\u6027\u7642\u6cd5\u7684\u5efa\u8b70\u76f8\u4e00\u81f4\uff0c\u8a72\u5efa\u8b70\u6307\u51fa\uff1a\u300cctDNA \u4f5c\u70ba\u751f\u7269\u6a19\u8a18\u7269\uff0c\u5728\u65e9\u671f\u968e\u6bb5\u5177\u6709\u591a\u7a2e\u6f5b\u5728\u7684\u76e3\u7ba1\u548c\u81e8\u5e8a\u7528\u9014\uff0c\u53ef\u80fd\u6709\u52a9\u65bc\u4e26\u52a0\u901f\u85e5\u7269\u958b\u767c\u3002\u300d(5) \u95dc\u65bc Gene Solutions Gene Solutions \u662f\u4e00\u5bb6\u4e9e\u6d32\u8de8\u570b\u751f\u7269\u79d1\u6280\u516c\u53f8\uff0c\u5728\u5229\u7528\u5148\u9032\u7684\u4eba\u5de5\u667a\u80fd (AI) \u548c ctDNA \u6280\u8853\u63d0\u4f9b\u5275\u65b0\u764c\u75c7\u6aa2\u6e2c\u89e3\u6c7a\u65b9\u6848\u65b9\u9762\u8655\u65bc\u9818\u5148\u5730\u4f4d\u3002\u516c\u53f8\u8207\u6771\u5357\u4e9e 4,500 \u591a\u5bb6\u91ab\u9662\u548c\u8a3a\u6240\u5408\u4f5c\uff0c\u64c1\u6709\u4e00\u652f\u7531\u7d04 250 \u540d\u751f\u7269\u5b78\u5c08\u5bb6\u548c\u6280\u8853\u4eba\u54e1\u7d44\u6210\u7684\u5c08\u696d\u5718\u968a\uff0c\u54e1\u5de5\u7e3d\u6578\u9054 700 \u4eba\u3002 Gene Solutions \u5df2\u5728\u6771\u5357\u4e9e\u5730\u5340\u767c\u8868\u4e86 50 \u591a\u7bc7\u540c\u884c\u8a55\u5be9\u7684\u8ad6\u6587\uff0c\u4e26\u958b\u5c55\u4e86 50 \u591a\u9805\u591a\u4e2d\u5fc3\u7814\u7a76\uff0c\u5176\u81ea\u4e3b\u7814\u767c\u6210\u679c\u4ee5\u53ca\u4f4d\u65bc\u65b0\u52a0\u5761\u548c\u8d8a\u5357\u7684 CAP \u8a8d\u8b49\u7684\u65b0\u4e00\u4ee3\u6e2c\u5e8f (NGS) \u5be6\u9a57\u5ba4\u5099\u53d7\u8a8d\u53ef\u3002\u901a\u904e\u5c07\u591a\u7dad\u57fa\u56e0\u7d44\u5b78\u8207\u4eba\u5de5\u667a\u80fd\u9a45\u52d5\u7684\u65b9\u6cd5\u76f8\u7d50\u5408\uff0c\u516c\u53f8\u81f4\u529b\u65bc\u8b8a\u9769\u764c\u75c7\u6cbb\u7642\uff0c\u4ee4\u66f4\u591a\u764c\u75c7\u60a3\u8005\u53d7\u76ca\u3002 Hoang, V.-A.N. et al. (2025) 'Real-World utilization and performance of circulating tumor DNA monitoring to predict recurrence in solid tumors,' JCO Oncology Advances, Volume 2. DOI: 10.1200\/OA-24-00084 Huang, J. et al. (2022) 'Cancer incidence and mortality in Asian countries: a trend analysis,' Cancer Control, 29. DOI:10.1177\/10732748221095955. Sharma, R. et al. (2024) 'Temporal patterns of cancer burden in Asia, 1990-2019: a systematic examination for the Global Burden of Disease 2019 study,' The Lancet Regional Health - Southeast Asia, 21, p. 100333. DOI:10.1016\/j.lansea.2023.100333. Kobayashi, S. et al. (2025) 'Japan society of clinical oncology position paper on appropriate clinical use of molecular residual disease (MRD) testing,' International Journal of Clinical Oncology . DOI:10.1007\/s10147-024-02683-0. Use of Circulating Tumor DNA for Curative-Intent Solid Tumor Drug Development. (2024). In Guidance for Industry . FDA Guidances, Content current as of: 01\/17\/2025.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/pingtungtimes.com.tw\/?p=315182\" \/>\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=\"2025-04-21T11:31:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/image_5022623_31897809.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"400\" \/>\n\t<meta property=\"og:image:height\" content=\"279\" \/>\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\t<meta name=\"twitter:label2\" content=\"\u9810\u4f30\u95b1\u8b80\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 \u5206\u9418\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"NewsArticle\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=315182#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=315182\"},\"author\":{\"name\":\"\u7f8e\u901a\u793e\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#\\\/schema\\\/person\\\/683b937f29ec1537972f6c41e22a2cf3\"},\"headline\":\"\u4e9e\u6d32\u9996\u500bctDNA-MRD\u771f\u5be6\u4e16\u754c\u7814\u7a76\u6210\u679c\u767c\u5e03\uff0c\u70ba\u9ad8\u6027\u50f9\u6bd4\u764c\u75c7\u76e3\u6e2c\u63d0\u4f9b\u6709\u529b\u8b49\u64da\",\"datePublished\":\"2025-04-21T11:31:00+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=315182\"},\"wordCount\":195,\"publisher\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=315182#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/wp-content\\\/uploads\\\/image_5022623_31897809.jpg\",\"articleSection\":[\"\u7f8e\u901a\u793e\"],\"inLanguage\":\"zh-TW\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=315182\",\"url\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=315182\",\"name\":\"\u4e9e\u6d32\u9996\u500bctDNA-MRD\u771f\u5be6\u4e16\u754c\u7814\u7a76\u6210\u679c\u767c\u5e03\uff0c\u70ba\u9ad8\u6027\u50f9\u6bd4\u764c\u75c7\u76e3\u6e2c\u63d0\u4f9b\u6709\u529b\u8b49\u64da - 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Tu \u8868\u793a\uff1a\u300c\u57fa\u65bc\u816b\u7624\u57fa\u56e0\u5716\u8b5c\u5206\u6790\u7684\u5c16\u7aef\u3001\u500b\u6027\u5316\u764c\u75c7\u6cbb\u7642\u548c\u76e3\u6e2c\u7684\u53ef\u53ca\u6027\uff0c\u5f80\u5f80\u53d6\u6c7a\u65bc\u60a3\u8005\u5c45\u4f4f\u5730\u6216\u7d93\u6fdf\u627f\u53d7\u80fd\u529b\u3002\u6211\u5011\u958b\u767c K-TRACK\u2122 \u7684\u4f7f\u547d\u6b63\u662f\u70ba\u4e86\u5f4c\u5408\u9019\u4e00\u5dee\u8ddd\uff0c\u63d0\u4f9b\u4e00\u7a2e\u50f9\u683c\u5408\u7406\u3001\u7cbe\u51c6\u4e14\u53ef\u7528\u65bc\u5e38\u898f\u81e8\u5e8a\u5be6\u8e10\u7684\u5be6\u6642\u89e3\u6c7a\u65b9\u6848\u3002\u300d Gene Solutions \u6b63\u7a4d\u6975\u6295\u5165\u5169\u5927\u95dc\u9375\u7814\u7a76\u65b9\u5411\uff1a 1.\u6301\u7e8c\u9032\u884c\u7684\u81e8\u5e8a\u8a66\u9a57\u548c\u771f\u5be6\u4e16\u754c\u7814\u7a76 \u516c\u53f8\u6b63\u5728\u9032\u884c\u5168\u9762\u7684\u7814\u7a76\uff0c\u4ee5\u9a57\u8b49 ctDNA \u5728\u5404\u7a2e\u764c\u75c7\u985e\u578b\u548c\u6cbb\u7642\u968e\u6bb5\u7684\u4f5c\u7528\u3002\u9019\u5305\u62ec\u8a55\u4f30\u80ba\u764c\u4e2d\u5c0d TKI \u548c\u514d\u75ab\u6aa2\u67e5\u9ede\u6291\u5236\u5291\uff08ICIs\uff09\u7684\u53cd\u61c9\u3001\u4e73\u817a\u764c\u7684\u65b0\u8f14\u52a9\u6cbb\u7642\u3001\u76f4\u8178\u764c\u7684\u5168\u7a0b\u65b0\u8f14\u52a9\u6cbb\u7642\uff0c\u4ee5\u53ca\u5229\u7528\u751f\u7269\u6a19\u5fd7\u7269\u6307\u5c0e\u665a\u671f\u764c\u75c7\u514d\u75ab\u6cbb\u7642\u6c7a\u7b56\u7b49\u3002 2.\u751f\u7269\u5236\u85e5\u5408\u4f5c Gene Solutions \u6b63\u7a4d\u6975\u5c0b\u6c42\u8207\u751f\u7269\u5236\u85e5\u516c\u53f8\u5408\u4f5c\uff0c\u63d0\u4f9b\u5275\u65b0\u89e3\u6c7a\u65b9\u6848\uff0c\u65e8\u5728\u52a0\u901f\u5404\u7a2e\u6cbb\u7642\u6a21\u5f0f\u7684\u85e5\u7269\u958b\u767c\u3002\u96a8\u8457\u652f\u6301 ctDNA \u7684\u79d1\u5b78\u8b49\u64da\u4e0d\u65b7\u589e\u591a\uff0cGene Solutions \u81f4\u529b\u65bc\u62d3\u5c55\u7814\u7a76\uff0c\u4e26\u8207\u73fe\u6709\u53ca\u65b0\u5408\u4f5c\u4f19\u4f34\u5efa\u7acb\u5408\u4f5c\u95dc\u7cfb\uff0c\u63a2\u7d22\u5176\u5728\u764c\u75c7\u6cbb\u7642\u9818\u57df\u7684\u65b0\u61c9\u7528\u3002\u516c\u53f8\u7684\u767c\u5c55\u65b9\u5411\u8207 FDA \u95dc\u65bc\u5c07 ctDNA \u7528\u4f5c\u751f\u7269\u6a19\u8a18\u7269\uff0c\u7528\u65bc\u958b\u767c\u5be6\u9ad4\u816b\u7624\u6cbb\u6108\u6027\u7642\u6cd5\u7684\u5efa\u8b70\u76f8\u4e00\u81f4\uff0c\u8a72\u5efa\u8b70\u6307\u51fa\uff1a\u300cctDNA \u4f5c\u70ba\u751f\u7269\u6a19\u8a18\u7269\uff0c\u5728\u65e9\u671f\u968e\u6bb5\u5177\u6709\u591a\u7a2e\u6f5b\u5728\u7684\u76e3\u7ba1\u548c\u81e8\u5e8a\u7528\u9014\uff0c\u53ef\u80fd\u6709\u52a9\u65bc\u4e26\u52a0\u901f\u85e5\u7269\u958b\u767c\u3002\u300d(5) \u95dc\u65bc Gene Solutions Gene Solutions \u662f\u4e00\u5bb6\u4e9e\u6d32\u8de8\u570b\u751f\u7269\u79d1\u6280\u516c\u53f8\uff0c\u5728\u5229\u7528\u5148\u9032\u7684\u4eba\u5de5\u667a\u80fd (AI) \u548c ctDNA \u6280\u8853\u63d0\u4f9b\u5275\u65b0\u764c\u75c7\u6aa2\u6e2c\u89e3\u6c7a\u65b9\u6848\u65b9\u9762\u8655\u65bc\u9818\u5148\u5730\u4f4d\u3002\u516c\u53f8\u8207\u6771\u5357\u4e9e 4,500 \u591a\u5bb6\u91ab\u9662\u548c\u8a3a\u6240\u5408\u4f5c\uff0c\u64c1\u6709\u4e00\u652f\u7531\u7d04 250 \u540d\u751f\u7269\u5b78\u5c08\u5bb6\u548c\u6280\u8853\u4eba\u54e1\u7d44\u6210\u7684\u5c08\u696d\u5718\u968a\uff0c\u54e1\u5de5\u7e3d\u6578\u9054 700 \u4eba\u3002 Gene Solutions \u5df2\u5728\u6771\u5357\u4e9e\u5730\u5340\u767c\u8868\u4e86 50 \u591a\u7bc7\u540c\u884c\u8a55\u5be9\u7684\u8ad6\u6587\uff0c\u4e26\u958b\u5c55\u4e86 50 \u591a\u9805\u591a\u4e2d\u5fc3\u7814\u7a76\uff0c\u5176\u81ea\u4e3b\u7814\u767c\u6210\u679c\u4ee5\u53ca\u4f4d\u65bc\u65b0\u52a0\u5761\u548c\u8d8a\u5357\u7684 CAP \u8a8d\u8b49\u7684\u65b0\u4e00\u4ee3\u6e2c\u5e8f (NGS) \u5be6\u9a57\u5ba4\u5099\u53d7\u8a8d\u53ef\u3002\u901a\u904e\u5c07\u591a\u7dad\u57fa\u56e0\u7d44\u5b78\u8207\u4eba\u5de5\u667a\u80fd\u9a45\u52d5\u7684\u65b9\u6cd5\u76f8\u7d50\u5408\uff0c\u516c\u53f8\u81f4\u529b\u65bc\u8b8a\u9769\u764c\u75c7\u6cbb\u7642\uff0c\u4ee4\u66f4\u591a\u764c\u75c7\u60a3\u8005\u53d7\u76ca\u3002 Hoang, V.-A.N. et al. (2025) 'Real-World utilization and performance of circulating tumor DNA monitoring to predict recurrence in solid tumors,' JCO Oncology Advances, Volume 2. DOI: 10.1200\\\/OA-24-00084 Huang, J. et al. (2022) 'Cancer incidence and mortality in Asian countries: a trend analysis,' Cancer Control, 29. DOI:10.1177\\\/10732748221095955. Sharma, R. et al. (2024) 'Temporal patterns of cancer burden in Asia, 1990-2019: a systematic examination for the Global Burden of Disease 2019 study,' The Lancet Regional Health - Southeast Asia, 21, p. 100333. DOI:10.1016\\\/j.lansea.2023.100333. Kobayashi, S. et al. (2025) 'Japan society of clinical oncology position paper on appropriate clinical use of molecular residual disease (MRD) testing,' International Journal of Clinical Oncology . DOI:10.1007\\\/s10147-024-02683-0. Use of Circulating Tumor DNA for Curative-Intent Solid Tumor Drug Development. (2024). In Guidance for Industry . 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Tu \u8868\u793a\uff1a\u300c\u57fa\u65bc\u816b\u7624\u57fa\u56e0\u5716\u8b5c\u5206\u6790\u7684\u5c16\u7aef\u3001\u500b\u6027\u5316\u764c\u75c7\u6cbb\u7642\u548c\u76e3\u6e2c\u7684\u53ef\u53ca\u6027\uff0c\u5f80\u5f80\u53d6\u6c7a\u65bc\u60a3\u8005\u5c45\u4f4f\u5730\u6216\u7d93\u6fdf\u627f\u53d7\u80fd\u529b\u3002\u6211\u5011\u958b\u767c K-TRACK\u2122 \u7684\u4f7f\u547d\u6b63\u662f\u70ba\u4e86\u5f4c\u5408\u9019\u4e00\u5dee\u8ddd\uff0c\u63d0\u4f9b\u4e00\u7a2e\u50f9\u683c\u5408\u7406\u3001\u7cbe\u51c6\u4e14\u53ef\u7528\u65bc\u5e38\u898f\u81e8\u5e8a\u5be6\u8e10\u7684\u5be6\u6642\u89e3\u6c7a\u65b9\u6848\u3002\u300d Gene Solutions \u6b63\u7a4d\u6975\u6295\u5165\u5169\u5927\u95dc\u9375\u7814\u7a76\u65b9\u5411\uff1a 1.\u6301\u7e8c\u9032\u884c\u7684\u81e8\u5e8a\u8a66\u9a57\u548c\u771f\u5be6\u4e16\u754c\u7814\u7a76 \u516c\u53f8\u6b63\u5728\u9032\u884c\u5168\u9762\u7684\u7814\u7a76\uff0c\u4ee5\u9a57\u8b49 ctDNA \u5728\u5404\u7a2e\u764c\u75c7\u985e\u578b\u548c\u6cbb\u7642\u968e\u6bb5\u7684\u4f5c\u7528\u3002\u9019\u5305\u62ec\u8a55\u4f30\u80ba\u764c\u4e2d\u5c0d TKI \u548c\u514d\u75ab\u6aa2\u67e5\u9ede\u6291\u5236\u5291\uff08ICIs\uff09\u7684\u53cd\u61c9\u3001\u4e73\u817a\u764c\u7684\u65b0\u8f14\u52a9\u6cbb\u7642\u3001\u76f4\u8178\u764c\u7684\u5168\u7a0b\u65b0\u8f14\u52a9\u6cbb\u7642\uff0c\u4ee5\u53ca\u5229\u7528\u751f\u7269\u6a19\u5fd7\u7269\u6307\u5c0e\u665a\u671f\u764c\u75c7\u514d\u75ab\u6cbb\u7642\u6c7a\u7b56\u7b49\u3002 2.\u751f\u7269\u5236\u85e5\u5408\u4f5c Gene Solutions \u6b63\u7a4d\u6975\u5c0b\u6c42\u8207\u751f\u7269\u5236\u85e5\u516c\u53f8\u5408\u4f5c\uff0c\u63d0\u4f9b\u5275\u65b0\u89e3\u6c7a\u65b9\u6848\uff0c\u65e8\u5728\u52a0\u901f\u5404\u7a2e\u6cbb\u7642\u6a21\u5f0f\u7684\u85e5\u7269\u958b\u767c\u3002\u96a8\u8457\u652f\u6301 ctDNA \u7684\u79d1\u5b78\u8b49\u64da\u4e0d\u65b7\u589e\u591a\uff0cGene Solutions \u81f4\u529b\u65bc\u62d3\u5c55\u7814\u7a76\uff0c\u4e26\u8207\u73fe\u6709\u53ca\u65b0\u5408\u4f5c\u4f19\u4f34\u5efa\u7acb\u5408\u4f5c\u95dc\u7cfb\uff0c\u63a2\u7d22\u5176\u5728\u764c\u75c7\u6cbb\u7642\u9818\u57df\u7684\u65b0\u61c9\u7528\u3002\u516c\u53f8\u7684\u767c\u5c55\u65b9\u5411\u8207 FDA \u95dc\u65bc\u5c07 ctDNA \u7528\u4f5c\u751f\u7269\u6a19\u8a18\u7269\uff0c\u7528\u65bc\u958b\u767c\u5be6\u9ad4\u816b\u7624\u6cbb\u6108\u6027\u7642\u6cd5\u7684\u5efa\u8b70\u76f8\u4e00\u81f4\uff0c\u8a72\u5efa\u8b70\u6307\u51fa\uff1a\u300cctDNA \u4f5c\u70ba\u751f\u7269\u6a19\u8a18\u7269\uff0c\u5728\u65e9\u671f\u968e\u6bb5\u5177\u6709\u591a\u7a2e\u6f5b\u5728\u7684\u76e3\u7ba1\u548c\u81e8\u5e8a\u7528\u9014\uff0c\u53ef\u80fd\u6709\u52a9\u65bc\u4e26\u52a0\u901f\u85e5\u7269\u958b\u767c\u3002\u300d(5) \u95dc\u65bc Gene Solutions Gene Solutions \u662f\u4e00\u5bb6\u4e9e\u6d32\u8de8\u570b\u751f\u7269\u79d1\u6280\u516c\u53f8\uff0c\u5728\u5229\u7528\u5148\u9032\u7684\u4eba\u5de5\u667a\u80fd (AI) \u548c ctDNA \u6280\u8853\u63d0\u4f9b\u5275\u65b0\u764c\u75c7\u6aa2\u6e2c\u89e3\u6c7a\u65b9\u6848\u65b9\u9762\u8655\u65bc\u9818\u5148\u5730\u4f4d\u3002\u516c\u53f8\u8207\u6771\u5357\u4e9e 4,500 \u591a\u5bb6\u91ab\u9662\u548c\u8a3a\u6240\u5408\u4f5c\uff0c\u64c1\u6709\u4e00\u652f\u7531\u7d04 250 \u540d\u751f\u7269\u5b78\u5c08\u5bb6\u548c\u6280\u8853\u4eba\u54e1\u7d44\u6210\u7684\u5c08\u696d\u5718\u968a\uff0c\u54e1\u5de5\u7e3d\u6578\u9054 700 \u4eba\u3002 Gene Solutions \u5df2\u5728\u6771\u5357\u4e9e\u5730\u5340\u767c\u8868\u4e86 50 \u591a\u7bc7\u540c\u884c\u8a55\u5be9\u7684\u8ad6\u6587\uff0c\u4e26\u958b\u5c55\u4e86 50 \u591a\u9805\u591a\u4e2d\u5fc3\u7814\u7a76\uff0c\u5176\u81ea\u4e3b\u7814\u767c\u6210\u679c\u4ee5\u53ca\u4f4d\u65bc\u65b0\u52a0\u5761\u548c\u8d8a\u5357\u7684 CAP \u8a8d\u8b49\u7684\u65b0\u4e00\u4ee3\u6e2c\u5e8f (NGS) \u5be6\u9a57\u5ba4\u5099\u53d7\u8a8d\u53ef\u3002\u901a\u904e\u5c07\u591a\u7dad\u57fa\u56e0\u7d44\u5b78\u8207\u4eba\u5de5\u667a\u80fd\u9a45\u52d5\u7684\u65b9\u6cd5\u76f8\u7d50\u5408\uff0c\u516c\u53f8\u81f4\u529b\u65bc\u8b8a\u9769\u764c\u75c7\u6cbb\u7642\uff0c\u4ee4\u66f4\u591a\u764c\u75c7\u60a3\u8005\u53d7\u76ca\u3002 Hoang, V.-A.N. et al. (2025) 'Real-World utilization and performance of circulating tumor DNA monitoring to predict recurrence in solid tumors,' JCO Oncology Advances, Volume 2. DOI: 10.1200\/OA-24-00084 Huang, J. et al. (2022) 'Cancer incidence and mortality in Asian countries: a trend analysis,' Cancer Control, 29. DOI:10.1177\/10732748221095955. Sharma, R. et al. (2024) 'Temporal patterns of cancer burden in Asia, 1990-2019: a systematic examination for the Global Burden of Disease 2019 study,' The Lancet Regional Health - Southeast Asia, 21, p. 100333. DOI:10.1016\/j.lansea.2023.100333. Kobayashi, S. et al. (2025) 'Japan society of clinical oncology position paper on appropriate clinical use of molecular residual disease (MRD) testing,' International Journal of Clinical Oncology . DOI:10.1007\/s10147-024-02683-0. Use of Circulating Tumor DNA for Curative-Intent Solid Tumor Drug Development. (2024). In Guidance for Industry . FDA Guidances, Content current as of: 01\/17\/2025.","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=315182","og_locale":"zh_TW","og_type":"article","og_title":"\u4e9e\u6d32\u9996\u500bctDNA-MRD\u771f\u5be6\u4e16\u754c\u7814\u7a76\u6210\u679c\u767c\u5e03\uff0c\u70ba\u9ad8\u6027\u50f9\u6bd4\u764c\u75c7\u76e3\u6e2c\u63d0\u4f9b\u6709\u529b\u8b49\u64da - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","og_description":"\u4e00\u9805\u65bc 2025 \u5e74 3 \u6708\u65b0\u8fd1\u767c\u8868\u65bc\u300aJCO Oncology Advances\u300b\u7684\u88e1\u7a0b\u7891\u5f0f\u7814\u7a76\uff0c\u7d0d\u5165623\u540d\u5be6\u9ad4\u7624\uff08\u5305\u62ec\u4e73\u817a\u764c\u3001\u7d50\u76f4\u8178\u764c\u3001\u80ba\u764c\u3001\u80c3\u764c\u3001\u809d\u764c\u548c\u5375\u5de2\u764c\u5171\u516d\u7a2e\u764c\u75c7\u985e\u5225\uff09\u60a3\u8005\uff0c\u5c55\u793a\u4e86\u5716 1. ctDNA \u5206\u6790\u5de5\u4f5c\u6d41\u7a0b\u3002\u5c0d\u65bc\u65e9\u671f I-III \u671f\u60a3\u8005\uff0c\u5c0d\u914d\u5c0d\u7684\u816b\u7624 FFPE \u548c WBC DNA \u6a23\u672c\u9032\u884c\u6e2c\u5e8f\uff0c\u4ee5\u8b58\u5225 155 \u500b\u764c\u75c7\u76f8\u95dc\u57fa\u56e0\u4e2d\u7684\u816b\u7624\u7279\u7570\u6027\u7a81\u8b8a\u3002\u5229\u7528\u6392\u5e8f\u5f97\u5206\u6700\u9ad8\u7684\u500b\u6027\u5316\u7a81\u8b8a\uff0c\u901a\u904e mPCR \u548c\u8d85\u6df1\u5ea6\u6e2c\u5e8f\u6aa2\u6e2c\u8840\u6f3f\u6a23\u672c\u4e2d\u7684 ctDNA\u3002\u5c0d\u65bc\u8f49\u79fb\u6027 IV \u671f\u60a3\u8005\uff0c\u9664\u4e86\u500b\u6027\u5316\u7a81\u8b8a\u5916\uff0c\u9084\u984d\u5916\u6dfb\u52a0\u4e86\u7d04 500 \u500b\u91dd\u5c0d\u6bcf\u7a2e\u764c\u75c7\u985e\u578b\u7279\u7570\u6027\u7684\u71b1\u9ede\u7a81\u8b8a\u7d44\u9032\u884c\u5206\u6790\u3002 ctDNA \u7684\u5be6\u6642\u76e3\u6e2c\u5df2\u88ab\u8b49\u660e\u53ef\u6709\u6548\u9810\u6e2c\u65e9\u671f\u764c\u75c7\u5fa9\u767c\uff0c\u5f9e\u800c\u53ca\u6642\u5e72\u9810\u4e26\u6539\u5584\u60a3\u8005\u9810\u5f8c\u3002\u7121\u8ad6\u662f\u65e9\u671f\u9084\u662f\u665a\u671f\u764c\u75c7\u60a3\u8005\uff0cK-TRACKTM \u90fd\u5c55\u73fe\u51fa\u6975\u9ad8\u7684\u5fa9\u767c\u9810\u6e2c\u51c6\u78ba\u6027\u3002\u8853\u5f8c 84.4% \u7684 ctDNA \u6aa2\u6e2c\u7d50\u679c\u5448\u967d\u6027\u7684\u60a3\u8005\u6700\u7d42\u5fa9\u767c\uff0c\u800c ctDNA \u6aa2\u6e2c\u7d50\u679c\u5448\u9670\u6027\u7684\u60a3\u8005\u4e2d\uff0c\u9ad8\u9054 96.3% \u7684\u60a3\u8005\u4ecd\u4fdd\u6301\u7121\u764c\u72c0\u614b\u3002\u6b64\u5916\uff0c\u8a72\u6aa2\u6e2c\u53ef\u6bd4\u5f71\u50cf\u5b78\u6aa2\u67e5\u7684\u81e8\u5e8a\u8a3a\u65b7\u63d0\u524d 5.5 \u81f3 19.5 \u500b\u6708\u767c\u73fe\u5fa9\u767c\u3002\u540c\u6642\uff0c6 \u500b\u6848\u4f8b\u7814\u7a76\u5c55\u793a\u4e86 ctDNA \u76e3\u6e2c\u5728\u9810\u6e2c\u6cbb\u7642\u53cd\u61c9\u3001\u6307\u5c0e\u8f14\u52a9\u5316\u7642\u6c7a\u7b56\u4ee5\u53ca\u8b58\u5225\u7576\u524d\u9776\u5411\u6cbb\u7642\u7684\u65b0\u8010\u85e5\u7a81\u8b8a\u65b9\u9762\u7684\u81e8\u5e8a\u61c9\u7528\u3002\u5f9e\u800c\u70ba\u81e8\u5e8a\u91ab\u751f\u63d0\u4f9b\u5be6\u6642\u3001\u53ef\u64cd\u4f5c\u7684\u6d1e\u5bdf\uff0c\u70ba\u6cbb\u7642\u6c7a\u7b56\u63d0\u4f9b\u53c3\u8003\u3002 \u5716 2. ctDNA \u5728\u65e9\u671f\u764c\u75c7\u4e2d\u7684\u9810\u5f8c\u50f9\u503c\u3002(A-D) \u6839\u64da\u8853\u5f8c ctDNA \u72c0\u614b\u5206\u5c64\u7684\u60a3\u8005\uff0c\u5c0d\u7121\u75c5\u751f\u5b58\u671f Disease-free survival (DFS) \u9032\u884c Kaplan-Meier \u5206\u6790\u3002(E) \u5c0d\u65bc\u7591\u4f3c\u5fa9\u767c\u7684\u60a3\u8005\uff0cctDNA \u7d50\u679c\u8207\u5f8c\u7e8c\u8a3a\u65b7\u7684\u4e00\u81f4\u6027\u70ba 87.0%\u3002(F) \u5728\u7591\u4f3c\u548c\u5e38\u898f\u76e3\u6e2c\u75c5\u4f8b\u4e2d\uff0cctDNA \u7684 Variant allele frequency (VAF) \u8207\u5fa9\u767c\u6642\u9593\u5747\u7121\u76f8\u95dc\u6027\u3002 \u516c\u5e73\u53ef\u53ca\u7684\u91ab\u7642\u9858\u666f Gene Solutions \u9996\u5e2d\u7814\u7a76\u54e1 Dr. Lan N. Tu \u8868\u793a\uff1a\u300c\u57fa\u65bc\u816b\u7624\u57fa\u56e0\u5716\u8b5c\u5206\u6790\u7684\u5c16\u7aef\u3001\u500b\u6027\u5316\u764c\u75c7\u6cbb\u7642\u548c\u76e3\u6e2c\u7684\u53ef\u53ca\u6027\uff0c\u5f80\u5f80\u53d6\u6c7a\u65bc\u60a3\u8005\u5c45\u4f4f\u5730\u6216\u7d93\u6fdf\u627f\u53d7\u80fd\u529b\u3002\u6211\u5011\u958b\u767c K-TRACK\u2122 \u7684\u4f7f\u547d\u6b63\u662f\u70ba\u4e86\u5f4c\u5408\u9019\u4e00\u5dee\u8ddd\uff0c\u63d0\u4f9b\u4e00\u7a2e\u50f9\u683c\u5408\u7406\u3001\u7cbe\u51c6\u4e14\u53ef\u7528\u65bc\u5e38\u898f\u81e8\u5e8a\u5be6\u8e10\u7684\u5be6\u6642\u89e3\u6c7a\u65b9\u6848\u3002\u300d Gene Solutions \u6b63\u7a4d\u6975\u6295\u5165\u5169\u5927\u95dc\u9375\u7814\u7a76\u65b9\u5411\uff1a 1.\u6301\u7e8c\u9032\u884c\u7684\u81e8\u5e8a\u8a66\u9a57\u548c\u771f\u5be6\u4e16\u754c\u7814\u7a76 \u516c\u53f8\u6b63\u5728\u9032\u884c\u5168\u9762\u7684\u7814\u7a76\uff0c\u4ee5\u9a57\u8b49 ctDNA \u5728\u5404\u7a2e\u764c\u75c7\u985e\u578b\u548c\u6cbb\u7642\u968e\u6bb5\u7684\u4f5c\u7528\u3002\u9019\u5305\u62ec\u8a55\u4f30\u80ba\u764c\u4e2d\u5c0d TKI \u548c\u514d\u75ab\u6aa2\u67e5\u9ede\u6291\u5236\u5291\uff08ICIs\uff09\u7684\u53cd\u61c9\u3001\u4e73\u817a\u764c\u7684\u65b0\u8f14\u52a9\u6cbb\u7642\u3001\u76f4\u8178\u764c\u7684\u5168\u7a0b\u65b0\u8f14\u52a9\u6cbb\u7642\uff0c\u4ee5\u53ca\u5229\u7528\u751f\u7269\u6a19\u5fd7\u7269\u6307\u5c0e\u665a\u671f\u764c\u75c7\u514d\u75ab\u6cbb\u7642\u6c7a\u7b56\u7b49\u3002 2.\u751f\u7269\u5236\u85e5\u5408\u4f5c Gene Solutions \u6b63\u7a4d\u6975\u5c0b\u6c42\u8207\u751f\u7269\u5236\u85e5\u516c\u53f8\u5408\u4f5c\uff0c\u63d0\u4f9b\u5275\u65b0\u89e3\u6c7a\u65b9\u6848\uff0c\u65e8\u5728\u52a0\u901f\u5404\u7a2e\u6cbb\u7642\u6a21\u5f0f\u7684\u85e5\u7269\u958b\u767c\u3002\u96a8\u8457\u652f\u6301 ctDNA \u7684\u79d1\u5b78\u8b49\u64da\u4e0d\u65b7\u589e\u591a\uff0cGene Solutions \u81f4\u529b\u65bc\u62d3\u5c55\u7814\u7a76\uff0c\u4e26\u8207\u73fe\u6709\u53ca\u65b0\u5408\u4f5c\u4f19\u4f34\u5efa\u7acb\u5408\u4f5c\u95dc\u7cfb\uff0c\u63a2\u7d22\u5176\u5728\u764c\u75c7\u6cbb\u7642\u9818\u57df\u7684\u65b0\u61c9\u7528\u3002\u516c\u53f8\u7684\u767c\u5c55\u65b9\u5411\u8207 FDA \u95dc\u65bc\u5c07 ctDNA \u7528\u4f5c\u751f\u7269\u6a19\u8a18\u7269\uff0c\u7528\u65bc\u958b\u767c\u5be6\u9ad4\u816b\u7624\u6cbb\u6108\u6027\u7642\u6cd5\u7684\u5efa\u8b70\u76f8\u4e00\u81f4\uff0c\u8a72\u5efa\u8b70\u6307\u51fa\uff1a\u300cctDNA \u4f5c\u70ba\u751f\u7269\u6a19\u8a18\u7269\uff0c\u5728\u65e9\u671f\u968e\u6bb5\u5177\u6709\u591a\u7a2e\u6f5b\u5728\u7684\u76e3\u7ba1\u548c\u81e8\u5e8a\u7528\u9014\uff0c\u53ef\u80fd\u6709\u52a9\u65bc\u4e26\u52a0\u901f\u85e5\u7269\u958b\u767c\u3002\u300d(5) \u95dc\u65bc Gene Solutions Gene Solutions \u662f\u4e00\u5bb6\u4e9e\u6d32\u8de8\u570b\u751f\u7269\u79d1\u6280\u516c\u53f8\uff0c\u5728\u5229\u7528\u5148\u9032\u7684\u4eba\u5de5\u667a\u80fd (AI) \u548c ctDNA \u6280\u8853\u63d0\u4f9b\u5275\u65b0\u764c\u75c7\u6aa2\u6e2c\u89e3\u6c7a\u65b9\u6848\u65b9\u9762\u8655\u65bc\u9818\u5148\u5730\u4f4d\u3002\u516c\u53f8\u8207\u6771\u5357\u4e9e 4,500 \u591a\u5bb6\u91ab\u9662\u548c\u8a3a\u6240\u5408\u4f5c\uff0c\u64c1\u6709\u4e00\u652f\u7531\u7d04 250 \u540d\u751f\u7269\u5b78\u5c08\u5bb6\u548c\u6280\u8853\u4eba\u54e1\u7d44\u6210\u7684\u5c08\u696d\u5718\u968a\uff0c\u54e1\u5de5\u7e3d\u6578\u9054 700 \u4eba\u3002 Gene Solutions \u5df2\u5728\u6771\u5357\u4e9e\u5730\u5340\u767c\u8868\u4e86 50 \u591a\u7bc7\u540c\u884c\u8a55\u5be9\u7684\u8ad6\u6587\uff0c\u4e26\u958b\u5c55\u4e86 50 \u591a\u9805\u591a\u4e2d\u5fc3\u7814\u7a76\uff0c\u5176\u81ea\u4e3b\u7814\u767c\u6210\u679c\u4ee5\u53ca\u4f4d\u65bc\u65b0\u52a0\u5761\u548c\u8d8a\u5357\u7684 CAP \u8a8d\u8b49\u7684\u65b0\u4e00\u4ee3\u6e2c\u5e8f (NGS) \u5be6\u9a57\u5ba4\u5099\u53d7\u8a8d\u53ef\u3002\u901a\u904e\u5c07\u591a\u7dad\u57fa\u56e0\u7d44\u5b78\u8207\u4eba\u5de5\u667a\u80fd\u9a45\u52d5\u7684\u65b9\u6cd5\u76f8\u7d50\u5408\uff0c\u516c\u53f8\u81f4\u529b\u65bc\u8b8a\u9769\u764c\u75c7\u6cbb\u7642\uff0c\u4ee4\u66f4\u591a\u764c\u75c7\u60a3\u8005\u53d7\u76ca\u3002 Hoang, V.-A.N. et al. (2025) 'Real-World utilization and performance of circulating tumor DNA monitoring to predict recurrence in solid tumors,' JCO Oncology Advances, Volume 2. DOI: 10.1200\/OA-24-00084 Huang, J. et al. (2022) 'Cancer incidence and mortality in Asian countries: a trend analysis,' Cancer Control, 29. DOI:10.1177\/10732748221095955. Sharma, R. et al. (2024) 'Temporal patterns of cancer burden in Asia, 1990-2019: a systematic examination for the Global Burden of Disease 2019 study,' The Lancet Regional Health - Southeast Asia, 21, p. 100333. DOI:10.1016\/j.lansea.2023.100333. Kobayashi, S. et al. (2025) 'Japan society of clinical oncology position paper on appropriate clinical use of molecular residual disease (MRD) testing,' International Journal of Clinical Oncology . DOI:10.1007\/s10147-024-02683-0. Use of Circulating Tumor DNA for Curative-Intent Solid Tumor Drug Development. (2024). In Guidance for Industry . 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Tu \u8868\u793a\uff1a\u300c\u57fa\u65bc\u816b\u7624\u57fa\u56e0\u5716\u8b5c\u5206\u6790\u7684\u5c16\u7aef\u3001\u500b\u6027\u5316\u764c\u75c7\u6cbb\u7642\u548c\u76e3\u6e2c\u7684\u53ef\u53ca\u6027\uff0c\u5f80\u5f80\u53d6\u6c7a\u65bc\u60a3\u8005\u5c45\u4f4f\u5730\u6216\u7d93\u6fdf\u627f\u53d7\u80fd\u529b\u3002\u6211\u5011\u958b\u767c K-TRACK\u2122 \u7684\u4f7f\u547d\u6b63\u662f\u70ba\u4e86\u5f4c\u5408\u9019\u4e00\u5dee\u8ddd\uff0c\u63d0\u4f9b\u4e00\u7a2e\u50f9\u683c\u5408\u7406\u3001\u7cbe\u51c6\u4e14\u53ef\u7528\u65bc\u5e38\u898f\u81e8\u5e8a\u5be6\u8e10\u7684\u5be6\u6642\u89e3\u6c7a\u65b9\u6848\u3002\u300d Gene Solutions \u6b63\u7a4d\u6975\u6295\u5165\u5169\u5927\u95dc\u9375\u7814\u7a76\u65b9\u5411\uff1a 1.\u6301\u7e8c\u9032\u884c\u7684\u81e8\u5e8a\u8a66\u9a57\u548c\u771f\u5be6\u4e16\u754c\u7814\u7a76 \u516c\u53f8\u6b63\u5728\u9032\u884c\u5168\u9762\u7684\u7814\u7a76\uff0c\u4ee5\u9a57\u8b49 ctDNA \u5728\u5404\u7a2e\u764c\u75c7\u985e\u578b\u548c\u6cbb\u7642\u968e\u6bb5\u7684\u4f5c\u7528\u3002\u9019\u5305\u62ec\u8a55\u4f30\u80ba\u764c\u4e2d\u5c0d TKI \u548c\u514d\u75ab\u6aa2\u67e5\u9ede\u6291\u5236\u5291\uff08ICIs\uff09\u7684\u53cd\u61c9\u3001\u4e73\u817a\u764c\u7684\u65b0\u8f14\u52a9\u6cbb\u7642\u3001\u76f4\u8178\u764c\u7684\u5168\u7a0b\u65b0\u8f14\u52a9\u6cbb\u7642\uff0c\u4ee5\u53ca\u5229\u7528\u751f\u7269\u6a19\u5fd7\u7269\u6307\u5c0e\u665a\u671f\u764c\u75c7\u514d\u75ab\u6cbb\u7642\u6c7a\u7b56\u7b49\u3002 2.\u751f\u7269\u5236\u85e5\u5408\u4f5c Gene Solutions \u6b63\u7a4d\u6975\u5c0b\u6c42\u8207\u751f\u7269\u5236\u85e5\u516c\u53f8\u5408\u4f5c\uff0c\u63d0\u4f9b\u5275\u65b0\u89e3\u6c7a\u65b9\u6848\uff0c\u65e8\u5728\u52a0\u901f\u5404\u7a2e\u6cbb\u7642\u6a21\u5f0f\u7684\u85e5\u7269\u958b\u767c\u3002\u96a8\u8457\u652f\u6301 ctDNA \u7684\u79d1\u5b78\u8b49\u64da\u4e0d\u65b7\u589e\u591a\uff0cGene Solutions \u81f4\u529b\u65bc\u62d3\u5c55\u7814\u7a76\uff0c\u4e26\u8207\u73fe\u6709\u53ca\u65b0\u5408\u4f5c\u4f19\u4f34\u5efa\u7acb\u5408\u4f5c\u95dc\u7cfb\uff0c\u63a2\u7d22\u5176\u5728\u764c\u75c7\u6cbb\u7642\u9818\u57df\u7684\u65b0\u61c9\u7528\u3002\u516c\u53f8\u7684\u767c\u5c55\u65b9\u5411\u8207 FDA \u95dc\u65bc\u5c07 ctDNA \u7528\u4f5c\u751f\u7269\u6a19\u8a18\u7269\uff0c\u7528\u65bc\u958b\u767c\u5be6\u9ad4\u816b\u7624\u6cbb\u6108\u6027\u7642\u6cd5\u7684\u5efa\u8b70\u76f8\u4e00\u81f4\uff0c\u8a72\u5efa\u8b70\u6307\u51fa\uff1a\u300cctDNA \u4f5c\u70ba\u751f\u7269\u6a19\u8a18\u7269\uff0c\u5728\u65e9\u671f\u968e\u6bb5\u5177\u6709\u591a\u7a2e\u6f5b\u5728\u7684\u76e3\u7ba1\u548c\u81e8\u5e8a\u7528\u9014\uff0c\u53ef\u80fd\u6709\u52a9\u65bc\u4e26\u52a0\u901f\u85e5\u7269\u958b\u767c\u3002\u300d(5) \u95dc\u65bc Gene Solutions Gene Solutions \u662f\u4e00\u5bb6\u4e9e\u6d32\u8de8\u570b\u751f\u7269\u79d1\u6280\u516c\u53f8\uff0c\u5728\u5229\u7528\u5148\u9032\u7684\u4eba\u5de5\u667a\u80fd (AI) \u548c ctDNA \u6280\u8853\u63d0\u4f9b\u5275\u65b0\u764c\u75c7\u6aa2\u6e2c\u89e3\u6c7a\u65b9\u6848\u65b9\u9762\u8655\u65bc\u9818\u5148\u5730\u4f4d\u3002\u516c\u53f8\u8207\u6771\u5357\u4e9e 4,500 \u591a\u5bb6\u91ab\u9662\u548c\u8a3a\u6240\u5408\u4f5c\uff0c\u64c1\u6709\u4e00\u652f\u7531\u7d04 250 \u540d\u751f\u7269\u5b78\u5c08\u5bb6\u548c\u6280\u8853\u4eba\u54e1\u7d44\u6210\u7684\u5c08\u696d\u5718\u968a\uff0c\u54e1\u5de5\u7e3d\u6578\u9054 700 \u4eba\u3002 Gene Solutions \u5df2\u5728\u6771\u5357\u4e9e\u5730\u5340\u767c\u8868\u4e86 50 \u591a\u7bc7\u540c\u884c\u8a55\u5be9\u7684\u8ad6\u6587\uff0c\u4e26\u958b\u5c55\u4e86 50 \u591a\u9805\u591a\u4e2d\u5fc3\u7814\u7a76\uff0c\u5176\u81ea\u4e3b\u7814\u767c\u6210\u679c\u4ee5\u53ca\u4f4d\u65bc\u65b0\u52a0\u5761\u548c\u8d8a\u5357\u7684 CAP \u8a8d\u8b49\u7684\u65b0\u4e00\u4ee3\u6e2c\u5e8f (NGS) \u5be6\u9a57\u5ba4\u5099\u53d7\u8a8d\u53ef\u3002\u901a\u904e\u5c07\u591a\u7dad\u57fa\u56e0\u7d44\u5b78\u8207\u4eba\u5de5\u667a\u80fd\u9a45\u52d5\u7684\u65b9\u6cd5\u76f8\u7d50\u5408\uff0c\u516c\u53f8\u81f4\u529b\u65bc\u8b8a\u9769\u764c\u75c7\u6cbb\u7642\uff0c\u4ee4\u66f4\u591a\u764c\u75c7\u60a3\u8005\u53d7\u76ca\u3002 Hoang, V.-A.N. et al. (2025) 'Real-World utilization and performance of circulating tumor DNA monitoring to predict recurrence in solid tumors,' JCO Oncology Advances, Volume 2. DOI: 10.1200\/OA-24-00084 Huang, J. et al. (2022) 'Cancer incidence and mortality in Asian countries: a trend analysis,' Cancer Control, 29. DOI:10.1177\/10732748221095955. Sharma, R. et al. (2024) 'Temporal patterns of cancer burden in Asia, 1990-2019: a systematic examination for the Global Burden of Disease 2019 study,' The Lancet Regional Health - Southeast Asia, 21, p. 100333. DOI:10.1016\/j.lansea.2023.100333. Kobayashi, S. et al. (2025) 'Japan society of clinical oncology position paper on appropriate clinical use of molecular residual disease (MRD) testing,' International Journal of Clinical Oncology . DOI:10.1007\/s10147-024-02683-0. Use of Circulating Tumor DNA for Curative-Intent Solid Tumor Drug Development. (2024). In Guidance for Industry . 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