{"id":7064,"date":"2023-07-03T09:05:15","date_gmt":"2023-07-03T09:05:15","guid":{"rendered":"\/\/smallcapscn.x5view.co\/?p=7064"},"modified":"2023-08-29T17:58:28","modified_gmt":"2023-08-29T17:58:28","slug":"lumos-diagnostics-receives-fda-clearance-market-febridx-us","status":"publish","type":"post","link":"https:\/\/smallcapscn.x5view.co\/?p=7064","title":{"rendered":"Lumos Diagnostics\u83b7\u5f97FDA\u6279\u51c6\u5728\u7f8e\u56fd\u9500\u552eFebriDx"},"content":{"rendered":"

Lumos Diagnostics (ASX: LDX) \u5df2\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40 (FDA) \u7684\u6279\u51c6\uff0c\u53ef\u4ee5\u5728\u7f8e\u56fd\u9500\u552e\u5176FebriDx\u5feb\u901f\u5373\u65f6\u68c0\u6d4b\u4ea7\u54c1\u3002<\/p>\n

FDA\u786e\u5b9a\u8bca\u65ad\u6d4b\u8bd5\u5df2\u7ecf\u8bc1\u660e\u4e86\u8be5\u516c\u53f8\u4eca\u5e74\u65e9\u4e9b\u65f6\u5019\u63d0\u4ea4\u7684510(k)\u4e0a\u5e02\u524d\u63d0\u4ea4\u7684\u201c\u4e0e\u8c13\u8bcd\u8bbe\u5907\u7684\u5b9e\u8d28\u7b49\u540c\u201d\u3002<\/p>\n

\u8be5\u4ea7\u54c1\u5df2\u83b7\u51c6\u5411\u7f8e\u56fd\u533b\u7597\u4fdd\u5065\u4e13\u4e1a\u4eba\u5458\u9500\u552e\uff0c\u7528\u4e8e\u8bca\u65ad\u7ec6\u83cc\u6027\u6025\u6027\u547c\u5438\u9053\u611f\u67d3\uff0c\u5e76\u5c06\u5176\u4e0e\u6025\u8bca\u60a3\u8005\u7684\u975e\u7ec6\u83cc\u6027(\u6216\u75c5\u6bd2)\u539f\u56e0\u533a\u5206\u5f00\u6765\u3002<\/p>\n

\u8be5\u6d4b\u8bd5\u53ef\u7528\u4e8e\u5e2e\u52a9\u62a4\u7406\u70b9\u7684\u51b3\u7b56\uff0c\u4ee5\u51cf\u5c11\u4e0d\u786e\u5b9a\u6027\uff0c\u907f\u514d\u4e0d\u5fc5\u8981\u7684\u6297\u751f\u7d20\uff0c\u5e76\u5b9e\u73b0\u9002\u5f53\u7684\u60a3\u8005\u7ba1\u7406\u3002<\/p>\n

\u7ed3\u679c\u53ef\u572810\u5206\u949f\u5185\u83b7\u5f97\uff0c99%\u9634\u6027\u9884\u6d4b\u503c(NPV)\u6392\u9664\u7ec6\u83cc\u611f\u67d3\u3002<\/p>\n

FebriDx\u5df2\u7ecf\u5728\u82f1\u56fd\u3001\u6b27\u6d32\u3001\u52a0\u62ff\u5927\u3001\u963f\u62c9\u4f2f\u8054\u5408\u914b\u957f\u56fd\u3001\u5df4\u897f\u3001\u571f\u8033\u5176\u3001\u5df4\u57fa\u65af\u5766\u3001\u65b0\u52a0\u5761\u3001\u9a6c\u6765\u897f\u4e9a\u548c\u6fb3\u5927\u5229\u4e9a\u6ce8\u518c\u3002<\/p>\n

\u786e\u4fdd\u8bb8\u53ef\u548c\u8ba2\u5355<\/h2>\n

Lumos\u9996\u5e2d\u6267\u884c\u5b98Doug Ward\u5bf9FDA\u7684\u6279\u51c6\u8868\u793a\u6b22\u8fce\u3002<\/p>\n

\u4ed6\u8bf4: \u201c\u6211\u4eec\u5f88\u9ad8\u5174\u7ec8\u4e8e\u83b7\u5f97\u4e86FebriDx\u5728\u7f8e\u56fd\u4e0a\u5e02\u7684\u8bb8\u53ef\uff0c\u56e0\u4e3a\u6211\u4eec\u76f8\u4fe1\u5b83\u5728\u6297\u751f\u7d20\u7ba1\u7406\u65b9\u9762\u53d1\u6325\u7740\u91cd\u8981\u4f5c\u7528\u3002\u201d<\/p>\n

\u201c\u6211\u4eec\u73b0\u5728\u9884\u8ba1\u5728\u5e74\u5e95\u524d\u83b7\u5f97\u9996\u6279\u5546\u4e1a\u8ba2\u5355\u2026\u2026\u6211\u4eec\u5c06\u7ee7\u7eed\u4e0e\u5206\u9500\u5408\u4f5c\u4f19\u4f34\u548c\u6f5c\u5728\u7684\u6388\u6743\u5546\u5408\u4f5c\uff0c\u5e76\u5efa\u7acb\u6211\u4eec\u81ea\u5df1\u7684\u91cd\u70b9\u9500\u552e\u5de5\u4f5c\uff0c\u56e0\u4e3a\u6211\u4eec\u51c6\u5907\u5728\u7f8e\u56fd\u63a8\u51faFebriDx\u3002\u201d<\/p>\n

\u4ed6\u8868\u793a\uff0c\u6765\u81ea\u56db\u4e2a\u6b27\u6d32\u5e02\u573a\u5206\u9500\u5546\u7684FebriDx\u8ba2\u5355\u4ecd\u7136\u76f8\u5bf9\u8f83\u5c11\uff0c\u4f46\u201c\u52bf\u5934\u5f00\u59cb\u589e\u5f3a\u201d\u3002<\/p>\n

\u6297\u751f\u7d20\u8010\u836f\u6027<\/h2>\n

\u6839\u636e\u533b\u5b66\u7814\u7a76\uff0c\u5927\u591a\u6570\u54b3\u55fd\u3001\u611f\u5192\u3001\u5589\u5499\u75db\u3001\u6d41\u9f3b\u6d95\u548c\u8033\u75db\u90fd\u662f\u7531\u75c5\u6bd2\u5f15\u8d77\u7684\uff0c\u4e0d\u9700\u8981\u6297\u751f\u7d20\u3002<\/p>\n

\u636e\u62a5\u544a\uff0c\u6297\u751f\u7d20\u8010\u836f\u6027\u5df2\u6210\u4e3a”\u91cd\u5927\u7684\u5168\u7403\u5065\u5eb7\u5a01\u80c1”\uff0c\u4e0d\u9002\u5f53\u6216\u4e0d\u5fc5\u8981\u7684\u5904\u65b9\u88ab\u8ba4\u4e3a\u662f\u5bfc\u81f4\u7ec6\u83cc\u75c5\u539f\u4f53\u6297\u5fae\u751f\u7269\u836f\u7269\u8010\u836f\u6027\u83cc\u682a\u5728\u5168\u7403\u65e5\u76ca\u51fa\u73b0\u7684\u4e00\u4e2a\u91cd\u8981\u56e0\u7d20\u3002<\/p>\n

2021\u5e74\uff0c\u7f8e\u56fd\u95e8\u8bca\u533b\u7597\u4fdd\u5065\u4e13\u4e1a\u4eba\u5458\u5f00\u51fa\u4e862.11\u4ebf\u5f20\u6297\u751f\u7d20\u5904\u65b9\uff0c\u76f8\u5f53\u4e8e\u6bcf1000\u540d\u60a3\u8005\u5f00\u51fa636\u5f20\u5904\u65b9\u3002<\/p>\n

Ward\u5148\u751f\u8bf4:\u201c\u5c3d\u7ba1\u6025\u6027\u547c\u5438\u9053\u611f\u67d3\u4e3b\u8981\u662f\u7531\u75c5\u6bd2\u5f15\u8d77\u7684\uff0c\u4f46\u636e\u62a5\u9053\uff0c\u5b83\u4eec\u662f\u5904\u65b9\u6297\u751f\u7d20\u7684\u6700\u5e38\u89c1\u8bca\u65ad\uff0c\u5176\u4e2d\u591a\u8fbe40%\u7684\u5904\u65b9\u88ab\u8ba4\u4e3a\u662f\u4e0d\u5fc5\u8981\u7684\u3002\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"

Lumos Diagnostics (ASX: LDX) \u5df2\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40 (FDA) \u7684\u6279\u51c6\uff0c\u53ef\u4ee5\u5728\u7f8e\u56fd\u9500\u552e\u5176FebriDx\u5feb\u901f\u5373\u65f6\u68c0\u6d4b\u4ea7\u54c1\u3002 FDA\u786e\u5b9a\u8bca\u65ad\u6d4b\u8bd5\u5df2\u7ecf\u8bc1\u660e\u4e86\u8be5\u516c\u53f8\u4eca\u5e74\u65e9\u4e9b\u65f6\u5019\u63d0\u4ea4\u7684510(k)\u4e0a\u5e02\u524d\u63d0\u4ea4\u7684\u201c\u4e0e\u8c13\u8bcd\u8bbe\u5907\u7684\u5b9e\u8d28\u7b49\u540c\u201d\u3002 \u8be5\u4ea7\u54c1\u5df2\u83b7\u51c6\u5411\u7f8e\u56fd\u533b\u7597\u4fdd\u5065\u4e13\u4e1a\u4eba\u5458\u9500\u552e\uff0c\u7528\u4e8e\u8bca\u65ad\u7ec6\u83cc\u6027\u6025\u6027\u547c\u5438\u9053\u611f\u67d3\uff0c\u5e76\u5c06\u5176\u4e0e\u6025\u8bca\u60a3\u8005\u7684\u975e\u7ec6\u83cc\u6027(\u6216\u75c5\u6bd2)\u539f\u56e0\u533a\u5206\u5f00\u6765\u3002 \u8be5\u6d4b\u8bd5\u53ef\u7528\u4e8e\u5e2e\u52a9\u62a4\u7406\u70b9\u7684\u51b3\u7b56\uff0c\u4ee5\u51cf\u5c11\u4e0d\u786e\u5b9a\u6027\uff0c\u907f\u514d\u4e0d\u5fc5\u8981\u7684\u6297\u751f\u7d20\uff0c\u5e76\u5b9e\u73b0\u9002\u5f53\u7684\u60a3\u8005\u7ba1\u7406\u3002 \u7ed3\u679c\u53ef\u572810\u5206\u949f\u5185\u83b7\u5f97\uff0c99%\u9634\u6027\u9884\u6d4b\u503c(NPV)\u6392\u9664\u7ec6\u83cc\u611f\u67d3\u3002 FebriDx\u5df2\u7ecf\u5728\u82f1\u56fd\u3001\u6b27\u6d32\u3001\u52a0\u62ff\u5927\u3001\u963f\u62c9\u4f2f\u8054\u5408\u914b\u957f\u56fd\u3001\u5df4\u897f\u3001\u571f\u8033\u5176\u3001\u5df4\u57fa\u65af\u5766\u3001\u65b0\u52a0\u5761\u3001\u9a6c\u6765\u897f\u4e9a\u548c\u6fb3\u5927\u5229\u4e9a\u6ce8\u518c\u3002 \u786e\u4fdd\u8bb8\u53ef\u548c\u8ba2\u5355 Lumos\u9996\u5e2d\u6267\u884c\u5b98Doug Ward\u5bf9FDA\u7684\u6279\u51c6\u8868\u793a\u6b22\u8fce\u3002 \u4ed6\u8bf4: \u201c\u6211\u4eec\u5f88\u9ad8\u5174\u7ec8\u4e8e\u83b7\u5f97\u4e86FebriDx\u5728\u7f8e\u56fd\u4e0a\u5e02\u7684\u8bb8\u53ef\uff0c\u56e0\u4e3a\u6211\u4eec\u76f8\u4fe1\u5b83\u5728\u6297\u751f\u7d20\u7ba1\u7406\u65b9\u9762\u53d1\u6325\u7740\u91cd\u8981\u4f5c\u7528\u3002\u201d \u201c\u6211\u4eec\u73b0\u5728\u9884\u8ba1\u5728\u5e74\u5e95\u524d\u83b7\u5f97\u9996\u6279\u5546\u4e1a\u8ba2\u5355\u2026\u2026\u6211\u4eec\u5c06\u7ee7\u7eed\u4e0e\u5206\u9500\u5408\u4f5c\u4f19\u4f34\u548c\u6f5c\u5728\u7684\u6388\u6743\u5546\u5408\u4f5c\uff0c\u5e76\u5efa\u7acb\u6211\u4eec\u81ea\u5df1\u7684\u91cd\u70b9\u9500\u552e\u5de5\u4f5c\uff0c\u56e0\u4e3a\u6211\u4eec\u51c6\u5907\u5728\u7f8e\u56fd\u63a8\u51faFebriDx\u3002\u201d \u4ed6\u8868\u793a\uff0c\u6765\u81ea\u56db\u4e2a\u6b27\u6d32\u5e02\u573a\u5206\u9500\u5546\u7684FebriDx\u8ba2\u5355\u4ecd\u7136\u76f8\u5bf9\u8f83\u5c11\uff0c\u4f46\u201c\u52bf\u5934\u5f00\u59cb\u589e\u5f3a\u201d\u3002 \u6297\u751f\u7d20\u8010\u836f\u6027 \u6839\u636e\u533b\u5b66\u7814\u7a76\uff0c\u5927\u591a\u6570\u54b3\u55fd\u3001\u611f\u5192\u3001\u5589\u5499\u75db\u3001\u6d41\u9f3b\u6d95\u548c\u8033\u75db\u90fd\u662f\u7531\u75c5\u6bd2\u5f15\u8d77\u7684\uff0c\u4e0d\u9700\u8981\u6297\u751f\u7d20\u3002 \u636e\u62a5\u544a\uff0c\u6297\u751f\u7d20\u8010\u836f\u6027\u5df2\u6210\u4e3a”\u91cd\u5927\u7684\u5168\u7403\u5065\u5eb7\u5a01\u80c1”\uff0c\u4e0d\u9002\u5f53\u6216\u4e0d\u5fc5\u8981\u7684\u5904\u65b9\u88ab\u8ba4\u4e3a\u662f\u5bfc\u81f4\u7ec6\u83cc\u75c5\u539f\u4f53\u6297\u5fae\u751f\u7269\u836f\u7269\u8010\u836f\u6027\u83cc\u682a\u5728\u5168\u7403\u65e5\u76ca\u51fa\u73b0\u7684\u4e00\u4e2a\u91cd\u8981\u56e0\u7d20\u3002 2021\u5e74\uff0c\u7f8e\u56fd\u95e8\u8bca\u533b\u7597\u4fdd\u5065\u4e13\u4e1a\u4eba\u5458\u5f00\u51fa\u4e862.11\u4ebf\u5f20\u6297\u751f\u7d20\u5904\u65b9\uff0c\u76f8\u5f53\u4e8e\u6bcf1000\u540d\u60a3\u8005\u5f00\u51fa636\u5f20\u5904\u65b9\u3002 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