{"id":1166,"date":"2020-03-17T14:15:02","date_gmt":"2020-03-17T14:15:02","guid":{"rendered":"https:\/\/www.almacgroup.com\/diagnostics\/?post_type=diagnostic_resource&#038;p=1166"},"modified":"2020-03-17T14:15:04","modified_gmt":"2020-03-17T14:15:04","slug":"cdx-ngs-and-regulation-five-perspectives-from-the-pistoia-alliance","status":"publish","type":"diagnostic_resource","link":"https:\/\/www.almacgroup.com\/diagnostics\/diagnostic-resource\/cdx-ngs-and-regulation-five-perspectives-from-the-pistoia-alliance\/","title":{"rendered":"CDx, NGS and regulation: five perspectives from the Pistoia Alliance"},"content":{"rendered":"\n<p>Dr Stewart McWilliams, VP of Quality and Regulatory Affairs at Almac Diagnostic Services, in conjunction with John Wise and Mike Furness from the Pistoia Alliance and Simon Patton from EMQN have produced an interesting paper on CDx, NGS and Regulation \u2013 Five Perspectives.<\/p>\n\n\n\n<p>Companion diagnostics (CDx) are essential to the practice of precision medicine. Next-generation sequencing is an increasingly important tool in the development of CDx. However, for CDx to be deployed, many different biopharma industry sectors need to collaborate. This paper outlines some of the challenges and opportunities perceived by the biopharmaceutical industry, the Europe Molecular Quality Network, a regulatory agency, a notified body, and a CDx service provider.<\/p>\n\n\n\n<p><a href=\"https:\/\/www.almacgroup.com\/wp-content\/uploads\/2019\/07\/DX_CDx-NGS-and-Regulation_Article.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Click here to download<\/a><\/p>\n","protected":false},"featured_media":0,"template":"","diagnostics_type":[475],"class_list":["post-1166","diagnostic_resource","type-diagnostic_resource","status-publish","hentry","diagnostics_type-diagnostics-articles"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.3.1 (Yoast SEO v26.3) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>CDx, NGS and regulation: five perspectives from the Pistoia Alliance - Diagnostic Services<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.almacgroup.com\/diagnostics\/diagnostic-resource\/cdx-ngs-and-regulation-five-perspectives-from-the-pistoia-alliance\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CDx, NGS and regulation: five perspectives from the Pistoia Alliance\" \/>\n<meta property=\"og:description\" content=\"Dr Stewart McWilliams, VP of Quality and Regulatory Affairs at Almac Diagnostic Services, in conjunction with John Wise and Mike Furness from the Pistoia Alliance and Simon Patton from EMQN have produced an interesting paper on CDx, NGS and Regulation \u2013 Five Perspectives. Companion diagnostics (CDx) are essential to the practice of precision medicine. Next-generation [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.almacgroup.com\/diagnostics\/diagnostic-resource\/cdx-ngs-and-regulation-five-perspectives-from-the-pistoia-alliance\/\" \/>\n<meta property=\"og:site_name\" content=\"Diagnostic Services\" \/>\n<meta property=\"article:modified_time\" content=\"2020-03-17T14:15:04+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/11\/Almac_Logo-e1698941154737.jpeg\" \/>\n\t<meta property=\"og:image:width\" content=\"100\" \/>\n\t<meta property=\"og:image:height\" content=\"52\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Estimated reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.almacgroup.com\/diagnostics\/diagnostic-resource\/cdx-ngs-and-regulation-five-perspectives-from-the-pistoia-alliance\/\",\"url\":\"https:\/\/www.almacgroup.com\/diagnostics\/diagnostic-resource\/cdx-ngs-and-regulation-five-perspectives-from-the-pistoia-alliance\/\",\"name\":\"CDx, NGS and regulation: five perspectives from the Pistoia Alliance - Diagnostic Services\",\"isPartOf\":{\"@id\":\"https:\/\/www.almacgroup.com\/diagnostics\/#website\"},\"datePublished\":\"2020-03-17T14:15:02+00:00\",\"dateModified\":\"2020-03-17T14:15:04+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/www.almacgroup.com\/diagnostics\/diagnostic-resource\/cdx-ngs-and-regulation-five-perspectives-from-the-pistoia-alliance\/#breadcrumb\"},\"inLanguage\":\"en-GB\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.almacgroup.com\/diagnostics\/diagnostic-resource\/cdx-ngs-and-regulation-five-perspectives-from-the-pistoia-alliance\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.almacgroup.com\/diagnostics\/diagnostic-resource\/cdx-ngs-and-regulation-five-perspectives-from-the-pistoia-alliance\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.almacgroup.com\/diagnostics\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"CDx, NGS and regulation: five perspectives from the Pistoia Alliance\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.almacgroup.com\/diagnostics\/#website\",\"url\":\"https:\/\/www.almacgroup.com\/diagnostics\/\",\"name\":\"Diagnostic Services\",\"description\":\"Just another Almac Core Sites site\",\"publisher\":{\"@id\":\"https:\/\/www.almacgroup.com\/diagnostics\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.almacgroup.com\/diagnostics\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-GB\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.almacgroup.com\/diagnostics\/#organization\",\"name\":\"Almac Group Ltd\",\"url\":\"https:\/\/www.almacgroup.com\/diagnostics\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-GB\",\"@id\":\"https:\/\/www.almacgroup.com\/diagnostics\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/04\/almac-logo-with-strapline.jpg\",\"contentUrl\":\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/04\/almac-logo-with-strapline.jpg\",\"width\":643,\"height\":296,\"caption\":\"Almac Group Ltd\"},\"image\":{\"@id\":\"https:\/\/www.almacgroup.com\/diagnostics\/#\/schema\/logo\/image\/\"}}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"CDx, NGS and regulation: five perspectives from the Pistoia Alliance - Diagnostic Services","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:\/\/www.almacgroup.com\/diagnostics\/diagnostic-resource\/cdx-ngs-and-regulation-five-perspectives-from-the-pistoia-alliance\/","og_locale":"en_GB","og_type":"article","og_title":"CDx, NGS and regulation: five perspectives from the Pistoia Alliance","og_description":"Dr Stewart McWilliams, VP of Quality and Regulatory Affairs at Almac Diagnostic Services, in conjunction with John Wise and Mike Furness from the Pistoia Alliance and Simon Patton from EMQN have produced an interesting paper on CDx, NGS and Regulation \u2013 Five Perspectives. 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