{"id":45751,"date":"2025-11-04T21:12:19","date_gmt":"2025-11-04T13:12:19","guid":{"rendered":"https:\/\/flcube.com\/?p=45751"},"modified":"2025-11-04T21:12:20","modified_gmt":"2025-11-04T13:12:20","slug":"amoy-diagnostics-announce-nmpa-approval-of-chinas-first-kras-g12c-companion-diagnostic","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=45751","title":{"rendered":"Amoy Diagnostics Announce NMPA Approval of China\u2019s First KRAS\u202fG12C Companion Diagnostic"},"content":{"rendered":"\n<p>Amoy Diagnostics Co., Ltd. (&#8220;AmoyDx&#8221;) have secured approval from the China National Medical Products Administration (NMPA) for the <strong>AmoyDx Pan Lung Cancer PCR (PLC) Panel<\/strong>. This milestone reflects the successful completion of a pivotal, concurrent clinical study that paired the diagnostic reagent with <strong>KRAS\u202fG12C<\/strong> inhibitor garsorasib, brought to market by Chia Tai Tianqing Pharmaceutical Group (CTTQ).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-a-precision-tool-for-non-small-cell-lung-cancer\">A Precision Tool for Non\u2011Small Cell Lung Cancer<\/h3>\n\n\n\n<p>The PLC Panel\u2014leveraging state\u2011of\u2011the\u2011art PCR technology\u2014simultaneously detects activating mutations across <strong>11 key driver genes<\/strong> (EGFR, ALK, ROS1, KRAS, BRAF, HER2, RET, MET, NTRK1, NTRK2, NTRK3). This breadth of coverage not only streamlines genetic profiling but also pinpoints patients whose tumors harbor the clinically actionable KRAS\u202fG12C alteration.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-first-in-china-kras-g12c-companion-diagnostic\">First\u2011In\u2011China KRAS\u202fG12C Companion Diagnostic<\/h3>\n\n\n\n<p>China\u2019s first <strong>KRAS\u202fG12C<\/strong> companion diagnostic product offers a new precision\u2011diagnosis and treatment paradigm for non\u2011small cell lung cancer (NSCLC) patients. Coupled with garsorasib\u2014CTTQ\u2019s licensed KRAS\u202fG12C inhibitor (approved November\u202f8,\u202f2024)\u2014the PLC Panel supports a matched\u2011therapy approach that is rapidly adopted across China, Japan, and Europe.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-market-impact-and-strategic-positioning\">Market Impact and Strategic Positioning<\/h3>\n\n\n\n<p>AmoyDx\u2019s PLC Panel has already achieved marketing approval in Japan and Europe, reinforcing its cross\u2011regional credibility. Riken Genesis\u2019 collaboration with AmoyDx expands its diagnostic footprint while positioning both firms favorably for potential co\u2011development and distribution deals in emerging precision\u2011medicine markets.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Amoy Diagnostics Co., Ltd. (&#8220;AmoyDx&#8221;) have secured approval from the China National Medical Products Administration&#8230;<\/p>\n","protected":false},"author":1,"featured_media":45754,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,22],"tags":[241,661,15,4427],"class_list":["post-45751","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-medical-device","tag-amoy-diagnostics","tag-chia-tai-tianqing-pharmaceutical","tag-product-approvals","tag-riken-genesis"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Amoy Diagnostics Announce NMPA Approval of China\u2019s First KRAS\u202fG12C Companion Diagnostic - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Amoy Diagnostics Co., Ltd. (&quot;AmoyDx&quot;) have secured approval from the China National Medical Products Administration (NMPA) for the AmoyDx Pan Lung Cancer PCR (PLC) Panel. This milestone reflects the successful completion of a pivotal, concurrent clinical study that paired the diagnostic reagent with KRAS\u202fG12C inhibitor garsorasib, brought to market by Chia Tai Tianqing Pharmaceutical Group (CTTQ).\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=45751\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Amoy Diagnostics Announce NMPA Approval of China\u2019s First KRAS\u202fG12C Companion Diagnostic\" \/>\n<meta property=\"og:description\" content=\"Amoy Diagnostics Co., Ltd. (&quot;AmoyDx&quot;) have secured approval from the China National Medical Products Administration (NMPA) for the AmoyDx Pan Lung Cancer PCR (PLC) Panel. 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