{"id":4138,"date":"2024-11-11T07:00:00","date_gmt":"2024-11-11T07:00:00","guid":{"rendered":"https:\/\/moneycompass.com.my\/cn\/nordic-bioscience%e6%94%b6%e5%88%b0fda%e7%9a%84%e6%94%af%e6%8c%81%e4%bf%a1\/"},"modified":"2024-11-11T07:00:00","modified_gmt":"2024-11-11T07:00:00","slug":"nordic-bioscience%e6%94%b6%e5%88%b0fda%e7%9a%84%e6%94%af%e6%8c%81%e4%bf%a1","status":"publish","type":"post","link":"https:\/\/moneycompass.com.my\/cn\/nordic-bioscience%e6%94%b6%e5%88%b0fda%e7%9a%84%e6%94%af%e6%8c%81%e4%bf%a1\/","title":{"rendered":"Nordic Bioscience\u6536\u5230FDA\u7684\u652f\u6301\u4fe1"},"content":{"rendered":"<p><span class=\"legendSpanClass\">\u4e39\u9ea6\u6d77\u83b1\u4e4c<\/span><span class=\"legendSpanClass\">2024\u5e7411\u670811\u65e5<\/span> \/\u7f8e\u901a\u793e\/ &#8212; \u9886\u5148\u7684\u751f\u7269\u6807\u5fd7\u7269\u516c\u53f8Nordic Bioscience\u5ba3\u5e03\uff0c\u5176CPa9-HNE\u751f\u7269\u6807\u5fd7\u7269\u68c0\u6d4b\u83b7\u5f97\u4e86U.S. Food and Drug Administration\uff08FDA\uff09\u7684\u652f\u6301\u4fe1\uff08Letter of Support\uff0c\u7b80\u79f0LoS\uff09\u3002<\/p>\n<div><\/div>\n<p>\u5728\u8fc7\u53bb\u7684\u4e09\u5341\u5e74\u91cc\uff0cNordic Bioscience\u5728\u9ad8\u5f71\u54cd\u529b\u671f\u520a\u4e0a\u53d1\u8868\u7684\u79d1\u5b66\u7a81\u7834\u3001\u5bf9\u9ad8\u7cbe\u5ea6\u81ea\u52a8\u5316\u4eea\u5668[1]\u7684\u6301\u7eed\u6539\u8fdb\uff0c\u4ee5\u53ca\u5b98\u65b9\u76d1\u7ba1\u90e8\u95e8\u7684\u4e00\u81f4\u6279\u51c6\u7684\u63a8\u52a8\u4e0b\uff0c\u4e0d\u65ad\u63a8\u8fdb\u5176ProteinFingerprint Biomarker Technology\u2122\u6280\u672f\u7684\u53d1\u5c55\u3002<\/p>\n<p>\u201c\u5353\u8d8a\u7684\u79d1\u5b66\u6210\u5c31\u3001\u9ad8\u8d28\u91cf\u7684\u751f\u7269\u6807\u5fd7\u7269\u4ee5\u53ca\u76d1\u7ba1\u673a\u6784\u7684\u652f\u6301\uff0c\u8fd9\u4e09\u5927\u4f18\u52bf\u4f7f\u6211\u4eec\u5728\u7ade\u4e89\u4e2d\u8131\u9896\u800c\u51fa\u3002\u201d Nordic Bioscience\u9996\u5e2d\u6267\u884c\u5b98Morten A. Karsdal\u8868\u793a\u3002 \u201cCPa9-HNE\u652f\u6301\u4fe1\u4e0d\u4ec5\u662f\u6211\u4eec\u6210\u529f\u6545\u4e8b\u4e2d\u7684\u53c8\u4e00\u4e2a\u91cc\u7a0b\u7891\u5f0f\u6210\u5c31\uff0c\u4e5f\u662f\u6211\u4eec\u8f9b\u52e4\u5de5\u4f5c\u7684\u56e2\u961f\u53ef\u4ee5\u6df1\u611f\u81ea\u8c6a\u7684\u6210\u679c\u3002\u201d<\/p>\n<p>CPa9-HNE\u751f\u7269\u6807\u5fd7\u7269\u7528\u4e8e\u6d4b\u91cf\u7531\u4eba\u7c7b\u4e2d\u6027\u7c92\u7ec6\u80de\u5f39\u6027\u86cb\u767d\u9176\u4ea7\u751f\u7684\u9499\u536b\u86cb\u767dS100a9\u7684\u4e00\u4e2a\u7247\u6bb5\u3002 \u5b83\u5728\u708e\u75c7\u6027\u80a0\u75c5\uff08IBD\uff09\u60a3\u8005\u7684\u8840\u6e05\u548c\u8840\u6d46\u4e2d\u68c0\u6d4b\u5230\uff0c\u5e76\u5b9a\u91cf\u6d3b\u5316\u7684\u4e2d\u6027\u7c92\u7ec6\u80de\uff0c\u63d0\u4f9b\u75be\u75c5\u6d3b\u52a8\u7684\u975e\u4fb5\u5165\u6027\u6307\u6807\u3002 \u5728IBD\u8bd5\u9a8c\u4e2d\uff0c\u4e00\u4e2a\u5e38\u89c1\u7684\u836f\u7269\u8bc4\u4f30\u76ee\u6807\u662f\u6cbb\u7597\u4e2d\u5ea6\u81f3\u91cd\u5ea6\u6e83\u75a1\u6027\u7ed3\u80a0\u708e\u6216\u514b\u7f57\u6069\u75c5\u60a3\u8005\u3002 \u4e2d\u6027\u7c92\u7ec6\u80de\u662f\u5bfc\u81f4IBD\u7684\u91cd\u8981\u514d\u75ab\u7ec6\u80de\uff0c\u800cCPa9-HNE\u80fd\u591f\u6539\u5584\u75be\u75c5\u6d3b\u52a8\u76d1\u6d4b\u3002<\/p>\n<p>\u201c\u8fd9\u5c01\u652f\u6301\u4fe1\u5f70\u663e\u4e86\u6211\u4eec\u5e0c\u671b\u901a\u8fc7CPa9-HNE\u5b9e\u73b0\u7684\u76ee\u6807\uff1a\u8fd9\u4e00\u6807\u5fd7\u7269\u6709\u53ef\u80fd\u4f5c\u4e3a\u672a\u6765\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u7684\u60a3\u8005\u7b5b\u9009\u5de5\u5177\uff0c\u5e2e\u52a9\u8bc6\u522b\u51fa\u66f4\u6709\u53ef\u80fd\u51fa\u73b0\u4e2d\u5ea6\u6216\u91cd\u5ea6\u5185\u7aa5\u955c\u4e0b\u75be\u75c5\u6d3b\u52a8\u7684\u60a3\u8005\u3002\u201dNordic Bioscience\u80c3\u80a0\u9053\u75be\u75c5\u79d1\u5b66\u603b\u76d1Joachim H\u00f8g Mortensen\u8865\u5145\u9053\u3002\u201c\u8fd9\u53ef\u4ee5\u5927\u5927\u7b80\u5316\u60a3\u8005\u62db\u52df\u6d41\u7a0b\uff0c\u786e\u4fdd\u7cbe\u51c6\u5b9a\u4f4d\u6b63\u786e\u7684\u60a3\u8005\u7fa4\u4f53\u3002 \u6b64\u5916\uff0cCPa9-HNE\u4f5c\u4e3a\u8840\u6e05\u9499\u536b\u86cb\u767d\u751f\u7269\u6807\u5fd7\u7269\uff0c\u53ef\u63d0\u4f9b\u57fa\u4e8e\u8840\u6db2\u7684\u75be\u75c5\u6d3b\u52a8\u6d4b\u91cf\u65b9\u6cd5\uff0c\u5e76\u6709\u671b\u7528\u4e8e\u76d1\u6d4b\u75be\u75c5\u6d3b\u52a8\u548c\u6cbb\u7597\u53cd\u5e94\u3002\u201d<\/p>\n<p>Nordic Bioscience\u5728ECM\u91cd\u5851\u7814\u7a76\u9886\u57df\u62e5\u6709\u6df1\u539a\u7684\u5386\u53f2\u79ef\u6dc0\uff0c\u5176PRO-C3\u548cPRO-C6\u751f\u7269\u6807\u5fd7\u7269\u83b7\u5f97\u4e86FDA\u7684\u652f\u6301\u4fe1\u3002 \u8be5\u516c\u53f8\u5df2\u5c06FDA\u6279\u51c6\u7684\u9aa8\u751f\u7269\u6807\u5fd7\u7269CTX-I\u548c\u7ea4\u7ef4\u751f\u6210\u751f\u7269\u6807\u5fd7\u7269PRO-C3\u8f6c\u79fb\u5230Roche COBAS\u5e73\u53f0\u3002 Nordic Bioscience\u5f00\u53d1\u4e86\u8d85\u8fc7125\u79cdELISA\u751f\u7269\u6807\u5fd7\u7269\u6765\u91cf\u5316\u72ec\u7279\u7684ECM\u7247\u6bb5\uff0c\u5176\u5de5\u5177\u7528\u4e8e\u5404\u79cd\u75be\u75c5\u7684\u836f\u7269\u5f00\u53d1\u548c\u60a3\u8005\u7b5b\u9009\u7684\u5404\u4e2a\u9636\u6bb5\u3002<\/p>\n<p>[1]CPa9-HNE\u76ee\u524d\u901a\u8fc7\u624b\u6301\u5f0fELISA\u68c0\u6d4b\u8fdb\u884c\u6d4b\u91cf\uff0c\u4f46\u9ad8\u7cbe\u5ea6\u81ea\u52a8\u5316\u5e73\u53f0\u7684\u5f00\u53d1\u5de5\u4f5c\u4ecd\u5728\u8fdb\u884c\u4e2d\u3002 \u4e0d\u9002\u7528\u4e8e\u8bca\u65ad\u7a0b\u5e8f\u3002<\/p>\n<p>\u8054\u7cfb\u4eba\uff1aElijah <a href=\"mailto:Aighobahi%EF%BC%8Ceai@nordicbio.com%EF%BC%8C+45\">Aighobahi\uff0ceai@nordicbio.com\uff0c+45<\/a> 4452 5252<\/p>\n<div><\/div>\n<p>\u00a0<\/p>\n<p>SOURCE  Nordic Bioscience<\/p>","protected":false},"excerpt":{"rendered":"<p>\u4e39\u9ea6\u6d77\u83b1\u4e4c2024\u5e7411\u670811\u65e5 \/\u7f8e\u901a\u793e\/ &#8212; \u9886\u5148\u7684\u751f\u7269\u6807\u5fd7\u7269\u516c\u53f8Nordic Bioscience\u5ba3\u5e03\uff0c\u5176CPa9-HNE\u751f\u7269\u6807\u5fd7\u7269\u68c0\u6d4b\u83b7\u5f97\u4e86U.S. Food and Drug Administration\uff08FDA\uff09\u7684\u652f\u6301\u4fe1\uff08Letter of Support\uff0c\u7b80\u79f0LoS\uff09\u3002 \u5728\u8fc7\u53bb\u7684\u4e09\u5341\u5e74\u91cc\uff0cNordic Bioscience\u5728\u9ad8\u5f71\u54cd\u529b\u671f\u520a\u4e0a\u53d1\u8868\u7684\u79d1\u5b66\u7a81\u7834\u3001\u5bf9\u9ad8\u7cbe\u5ea6\u81ea\u52a8\u5316\u4eea\u5668[1]\u7684\u6301\u7eed\u6539\u8fdb\uff0c\u4ee5\u53ca\u5b98\u65b9\u76d1\u7ba1\u90e8\u95e8\u7684\u4e00\u81f4\u6279\u51c6\u7684\u63a8\u52a8\u4e0b\uff0c\u4e0d\u65ad\u63a8\u8fdb\u5176ProteinFingerprint Biomarker Technology\u2122\u6280\u672f\u7684\u53d1\u5c55\u3002 \u201c\u5353\u8d8a\u7684\u79d1\u5b66\u6210\u5c31\u3001\u9ad8\u8d28\u91cf\u7684\u751f\u7269\u6807\u5fd7\u7269\u4ee5\u53ca\u76d1\u7ba1\u673a\u6784\u7684\u652f\u6301\uff0c\u8fd9\u4e09\u5927\u4f18\u52bf\u4f7f\u6211\u4eec\u5728\u7ade\u4e89\u4e2d\u8131\u9896\u800c\u51fa\u3002\u201d Nordic Bioscience\u9996\u5e2d\u6267\u884c\u5b98Morten A. 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