{"id":1442,"date":"2022-04-09T19:12:24","date_gmt":"2022-04-09T11:12:24","guid":{"rendered":"https:\/\/amdl.com.hk\/?page_id=1442"},"modified":"2022-07-15T02:26:26","modified_gmt":"2022-07-14T18:26:26","slug":"fda-authorization","status":"publish","type":"page","link":"https:\/\/amdl.com.hk\/zh\/fda-authorization\/","title":{"rendered":"FDA \u8a8d\u8b49"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1442\" class=\"elementor elementor-1442\" data-elementor-settings=\"{&quot;ha_cmc_init_switcher&quot;:&quot;no&quot;}\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2d3091fd e-flex e-con-boxed e-con e-parent\" data-id=\"2d3091fd\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;animation&quot;:&quot;none&quot;,&quot;_ha_eqh_enable&quot;:false,&quot;motion_fx_devices&quot;:[&quot;desktop&quot;,&quot;tablet&quot;,&quot;mobile&quot;]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-2adaa175 e-flex e-con-boxed e-con e-child\" data-id=\"2adaa175\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7806c344 elementor-widget elementor-widget-heading\" data-id=\"7806c344\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">FDA Authorization<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-74acf63c elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"74acf63c\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-70bdef24 elementor-invisible\" data-id=\"70bdef24\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeIn&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c008c88 elementor-invisible elementor-widget elementor-widget-image\" data-id=\"c008c88\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"848\" height=\"565\" src=\"https:\/\/amdl.com.hk\/wp-content\/uploads\/2022\/04\/fda.jpeg\" class=\"attachment-full size-full wp-image-3944\" alt=\"\" srcset=\"https:\/\/amdl.com.hk\/wp-content\/uploads\/2022\/04\/fda.jpeg 848w, https:\/\/amdl.com.hk\/wp-content\/uploads\/2022\/04\/fda-600x400.jpeg 600w, https:\/\/amdl.com.hk\/wp-content\/uploads\/2022\/04\/fda-300x200.jpeg 300w, https:\/\/amdl.com.hk\/wp-content\/uploads\/2022\/04\/fda-768x512.jpeg 768w\" sizes=\"(max-width: 848px) 100vw, 848px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-6880cadc elementor-invisible\" data-id=\"6880cadc\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;animation&quot;:&quot;fadeIn&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-55148a12 elementor-widget elementor-widget-heading\" data-id=\"55148a12\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">FDA Authorization<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-731177f1 elementor-widget elementor-widget-heading\" data-id=\"731177f1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">Companion Diagnostics (CDx) Test<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-445552e9 elementor-widget elementor-widget-text-editor\" data-id=\"445552e9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>At the heart of all FDA&#8217;s medical product evaluation decisions is a judgment about whether a new product&#8217;s benefits to users will outweigh its risks. No regulated product is totally risk-free, so these judgments are important. With the <span style=\"text-decoration: underline;\"><a href=\"https:\/\/amdl.com.hk\/assay-menus\/\">ONCO\/Reveal\u2122 Dx Lung and Colon Cancer Assay<\/a><\/span>,\u00a0 it is trustworthy that the listed colorectal cancer (CRC)-targeted therapies and non-small cell lung cancer (NSCLC)-targeted therapies can be used as one of the guidelines for prescription. It fills the loopholes in the usage of unstandardized medical device.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t<div class=\"elementor-element elementor-element-73084c9d e-flex e-con-boxed e-con e-parent\" data-id=\"73084c9d\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;none&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6eaa11a4 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"6eaa11a4\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">MiSeqDx System<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2c5275fa elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"2c5275fa\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>In Hong Kong. we are the first who utilize the MiSeq DX system to sequence the genetic profile in the tumour samples and generate report with guidelines for prescription. The MiSeqDx instrument meets stringent performance characteristics, so we can generate accurate and reliable data. For more details, please visit the website of <a href=\"https:\/\/sapac.illumina.com\/systems\/sequencing-platforms\/miseqdx.html\" target=\"_blank\" rel=\"noopener\">Illumina<\/a><strong>.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3df6a649 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"3df6a649\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;,&quot;background_background&quot;:&quot;classic&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-6f6fb9e9 e-con-full e-flex e-con e-child\" data-id=\"6f6fb9e9\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-29dcc509 elementor-tabs-view-horizontal elementor-widget elementor-widget-tabs\" data-id=\"29dcc509\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"tabs.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-tabs\">\n\t\t\t<div class=\"elementor-tabs-wrapper\" role=\"tablist\" >\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-7021\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"true\" data-tab=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"elementor-tab-content-7021\" aria-expanded=\"false\">NGS System<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-7022\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"2\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-7022\" aria-expanded=\"false\">IVD Menu<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-7023\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"3\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-7023\" aria-expanded=\"false\">Workflow<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-7024\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"4\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-7024\" aria-expanded=\"false\">Software<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t<div class=\"elementor-tabs-content-wrapper\" role=\"tablist\" aria-orientation=\"vertical\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"true\" data-tab=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"elementor-tab-content-7021\" aria-expanded=\"false\">NGS System<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-7021\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-7021\" tabindex=\"0\" hidden=\"false\"><h4 class=\"white-txt\">FDA-Regulated and CE-IVD-Marked NGS System<\/h4><p class=\"white-txt\">The MiSeqDx instrument is the first Food and Drug Administration (FDA)-regulated and Conformite Europeene\u00a0<em>in vitro<\/em>\u00a0diagnostic (CE-IVD)-marked platform for NGS. The MiSeqDx instrument meets stringent performance characteristics so you can feel confident you are generating accurate and reliable data. With the MiSeqDx System, clinicians and clinical laboratories now have the tools to obtain comprehensive and reliable DNA sequencing results.<\/p><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"2\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-7022\" aria-expanded=\"false\">IVD Menu<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-7022\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-7022\" tabindex=\"0\" hidden=\"hidden\"><h4 class=\"white-txt\">A Growing IVD Menu<\/h4><p class=\"white-txt\">Designed specifically for clinical laboratories, the MiSeqDx System delivers a broad range of sequencing applications right at your fingertips. Illumina offers two FDA-cleared cystic fibrosis assays and an FDA-approved companion diagnostic to aid in the identification of patients with colorectal cancer for treatment with Vectibix.*<\/p><p class=\"small white-txt\">*Vectibix is a registered trademark of Amgen, Inc.<\/p><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"3\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-7023\" aria-expanded=\"false\">Workflow<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-7023\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-7023\" tabindex=\"0\" hidden=\"hidden\"><h4 class=\"white-txt\">Simple NGS Workflow<\/h4><p class=\"white-txt\">The MiSeqDx instrument provides an easy-to-use, automated workflow. An intuitive touch screen interface makes for simple instrument operation. Plug-and-play reagents with RFID tracking make for added security and convenience. The MiSeqDx instrument eliminates the need for auxiliary hardware and computing resources, saving valuable lab space.<\/p><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"4\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-7024\" aria-expanded=\"false\">Software<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-7024\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-7024\" tabindex=\"0\" hidden=\"hidden\"><h4 class=\"white-txt\">User-Friendly, Intuitive Software<\/h4><p class=\"white-txt\">A user-friendly touch screen interface guides you as you create and set up your sample sheet, then load the sequencing cartridge (provided with pre-loaded reagents). During the run, the system allows you to monitor quality statistics. After DNA sequencing completes, the system software analyzes assay data and generates the results report.*<\/p><p class=\"small white-txt\">* Report generation is only available for the TruSight Cystic Fibrosis 139-Variant Assay, the TruSight Cystic Fibrosis Clinical Sequencing Assay, and the Extended RAS Panel.<\/p><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2cadfe61 e-con-full e-flex e-con e-child\" data-id=\"2cadfe61\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-59a9109d elementor-pagination-position-inside elementor-arrows-position-inside elementor-widget elementor-widget-image-carousel\" data-id=\"59a9109d\" data-element_type=\"widget\" data-e-type=\"widget\" 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role=\"button\" tabindex=\"0\">\n\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-eicon-chevron-right\" viewBox=\"0 0 1000 1000\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M696 533C708 521 713 504 713 487 713 471 708 454 696 446L400 146C388 133 375 125 354 125 338 125 325 129 313 142 300 154 292 171 292 187 292 204 296 221 308 233L563 492 304 771C292 783 288 800 288 817 288 833 296 850 308 863 321 871 338 875 354 875 371 875 388 867 400 854L696 533Z\"><\/path><\/svg>\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t<div class=\"swiper-pagination\"><\/div>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-db7049b e-flex e-con-boxed e-con e-parent\" data-id=\"db7049b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-4fee4f1 e-flex e-con-boxed e-con e-child\" data-id=\"4fee4f1\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f9d9995 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"f9d9995\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Workflow<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-01451a5 e-flex e-con-boxed elementor-invisible e-con e-child\" data-id=\"01451a5\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInUp&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-4e225b3 e-con-full e-flex e-con e-child\" data-id=\"4e225b3\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6c94a04 elementor-widget elementor-widget-image\" data-id=\"6c94a04\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1024\" height=\"562\" src=\"https:\/\/amdl.com.hk\/wp-content\/uploads\/2022\/05\/Process_\u5de5\u4f5c\u5340\u57df-1-1024x562.png\" class=\"attachment-large size-large wp-image-5022\" alt=\"\" srcset=\"https:\/\/amdl.com.hk\/wp-content\/uploads\/2022\/05\/Process_\u5de5\u4f5c\u5340\u57df-1-1024x562.png 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class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Choose from\u00a0our\u00a0menu of FDA-cleared assays available exclusively on the MiSeqDx System.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-11e31d5 e-con-full e-flex e-con e-child\" data-id=\"11e31d5\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-93c11aa elementor-widget elementor-widget-image\" data-id=\"93c11aa\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1024\" height=\"562\" src=\"https:\/\/amdl.com.hk\/wp-content\/uploads\/2022\/05\/Process-02-1024x562.png\" class=\"attachment-large size-large wp-image-5023\" alt=\"\" srcset=\"https:\/\/amdl.com.hk\/wp-content\/uploads\/2022\/05\/Process-02-1024x562.png 1024w, https:\/\/amdl.com.hk\/wp-content\/uploads\/2022\/05\/Process-02-600x329.png 600w, https:\/\/amdl.com.hk\/wp-content\/uploads\/2022\/05\/Process-02-300x165.png 300w, https:\/\/amdl.com.hk\/wp-content\/uploads\/2022\/05\/Process-02-768x421.png 768w, https:\/\/amdl.com.hk\/wp-content\/uploads\/2022\/05\/Process-02-1536x843.png 1536w, https:\/\/amdl.com.hk\/wp-content\/uploads\/2022\/05\/Process-02-1200x658.png 1200w, https:\/\/amdl.com.hk\/wp-content\/uploads\/2022\/05\/Process-02.png 1593w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1736532 elementor-widget elementor-widget-text-editor\" data-id=\"1736532\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The MiSeqDx instrument provides accurate, reliable\u00a0data for\u00a0screening and diagnostic testing.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-cd7eac9 e-con-full e-flex e-con e-child\" data-id=\"cd7eac9\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c10b9e3 elementor-widget elementor-widget-image\" data-id=\"c10b9e3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"561\" src=\"https:\/\/amdl.com.hk\/wp-content\/uploads\/2022\/05\/Process-03-1024x561.png\" class=\"attachment-large size-large wp-image-5024\" alt=\"\" srcset=\"https:\/\/amdl.com.hk\/wp-content\/uploads\/2022\/05\/Process-03-1024x561.png 1024w, https:\/\/amdl.com.hk\/wp-content\/uploads\/2022\/05\/Process-03-600x329.png 600w, https:\/\/amdl.com.hk\/wp-content\/uploads\/2022\/05\/Process-03-300x164.png 300w, https:\/\/amdl.com.hk\/wp-content\/uploads\/2022\/05\/Process-03-768x421.png 768w, https:\/\/amdl.com.hk\/wp-content\/uploads\/2022\/05\/Process-03-1536x842.png 1536w, https:\/\/amdl.com.hk\/wp-content\/uploads\/2022\/05\/Process-03-1200x658.png 1200w, https:\/\/amdl.com.hk\/wp-content\/uploads\/2022\/05\/Process-03.png 1594w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ad2d474 elementor-widget elementor-widget-text-editor\" data-id=\"ad2d474\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The selected analysis initiates automatically. It completes in a few hours and then generates a report.*<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>FDA \u8a8d\u8b49<br \/>\nCompanion Diagnostics (CDx) Test<br \/>\nAt the heart of all FDA\u2019s medical product evaluation decisions is a judgment about whether a new product\u2019s benefits to users will outweigh its risks. No regulated product is totally risk-free, so these judgments are important. With the ONCO\/Reveal\u2122 Dx Lung and Colon Cancer Assay,  it is trustworthy that the listed colorectal cancer (CRC)-targeted therapies and non-small cell lung cancer (NSCLC)-targeted therapies can be used as one of the guidelines for prescription. It fills the loopholes in the usage of unstandardized medical device.<\/p>\n<p>MiSeqDx System<br \/>\nIn Hong Kong. we are the first who utilize the MiSeq DX system to sequence the genetic profile in the tumour samples and generate report with guidelines for prescription. The MiSeqDx instrument meets stringent performance characteristics, so we can generate accurate and reliable data. For more details, please visit the website of Illumina (link: <a href=\"https:\/\/sapac.illumina.com\/systems\/sequencing-platforms\/miseqdx.html\" rel=\"nofollow\">https:\/\/sapac.illumina.com\/systems\/sequencing-platforms\/miseqdx.html<\/a>).<\/p>","protected":false},"author":214404990,"featured_media":6746,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-1442","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA Authorization | Asia Molecular Diagnostics Laboratory Limited (AMDL) \u4e9e\u6d32\u5206\u5b50\u8a3a\u65b7\u5be6\u9a57\u5ba4\u6709\u9650\u516c\u53f8 | \u9999\u6e2f Hong Kong<\/title>\n<meta name=\"description\" content=\"Asia Molecular Diagnostic Laboratory Limited (AMDL) \u4e9e\u6d32\u5206\u5b50\u8a3a\u65b7\u5be6\u9a57\u5ba4\u6709\u9650\u516c\u53f8 is a molecular diagnostic laboratory in Hong Kong. AMDL is a subsidiary of China Biotech Services Holdings Limited \u4e2d\u570b\u751f\u7269\u79d1\u6280\u670d\u52d9\u63a7\u80a1\u6709\u9650\u516c\u53f8. We have An NGS-level molecular laboratory at HKSTP. We are sole distributor of Pillar Biosciences products in Asia and providing world-leading NGS-based clinical testing products &amp; services for oncologist and clients in Hong Kong, China &amp; Asia. 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