{"id":16,"date":"2020-01-22T09:50:09","date_gmt":"2020-01-22T09:50:09","guid":{"rendered":"https:\/\/www.almacgroup.com\/diagnostics\/?page_id=16"},"modified":"2025-02-21T11:22:15","modified_gmt":"2025-02-21T11:22:15","slug":"cdx-development","status":"publish","type":"page","link":"https:\/\/www.almacgroup.com\/diagnostics\/clinical-trial-solutions\/cdx-development\/","title":{"rendered":"CDx Development &#038; Validation"},"content":{"rendered":"\n<h4 class=\"wp-block-heading has-large-font-size\">A Collaborative CDx Partnership Approach<\/h4>\n\n\n\n<p>When it comes to the discovery, development &amp; validation of companion diagnostics (CDx) for future precision medicines, no two pharmaceutical or biotech companies will ever have the same needs.<\/p>\n\n\n\n<p>At Almac Diagnostic Services, we understand these needs: timelines can be challenging, platform flexibility may be required, regulatory approaches may vary &amp; clinical studies often require bespoke methodologies.<\/p>\n\n\n\n<p>Almac Diagnostic Services has experience in CDx development from the fundamental research and discovery phase, through the conduct of clinical trials and the manufacturing of IVD kits or ssPMA lab developed tests, to the patient sample testing.<\/p>\n\n\n\n<p>We partner with Global Biopharma companies in a truly collaborative way, typically setting up joint steering committees with our partners to guide CDx development programmes as they progress towards commercialisation.<\/p>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"wp-block-heading has-medium-font-size\"><strong><strong>Complete Flexibility for your CDx Programme Needs<\/strong><\/strong><\/h4>\n\n\n\n<p>Our approach to CDx development &amp; validation has been designed to offer you complete flexibility, with a range of diagnostic platform and chemistry options and specialist supporting services, tailored to your specific drug and companion diagnostic development requirements.<\/p>\n\n\n\n<p><span style=\"text-decoration: underline;\">Our CDx Capabilities:<\/span><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Multiple Disease Areas<\/strong>&nbsp;(Experience in both Oncology and Non-Oncology Indications)<\/li>\n\n\n\n<li><strong>Platform Agility &amp; Strategic Commercial Agreements<\/strong>&nbsp;(NGS, qPCR)<\/li>\n\n\n\n<li><strong>Global Laboratory Facilities<\/strong>&nbsp;(UK\/EU, USA and China Partner Laboratories)<\/li>\n\n\n\n<li><strong>Flexible CDx Development &amp;&nbsp;<a href=\"\/diagnostics\/clinical-trial-solutions\/cdx-commercialisation\/\">CDx Commercialisation Models<\/a><\/strong>&nbsp;(ssPMA or IVD Kit)<\/li>\n<\/ul>\n\n\n\n<p><span style=\"text-decoration: underline;\">Our CDx Accreditations:<\/span><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Regulatory Submission Experience<\/strong>: FDA, MHRA and EMA<\/li>\n\n\n\n<li><strong>Laboratories:<\/strong>&nbsp;CLIA &amp; CAP certified and ISO17025 &amp; ISO15189 accredited<\/li>\n\n\n\n<li><strong>Manufacturing Accreditations:&nbsp;<\/strong>ISO13485 for design and development of IVD assays<\/li>\n\n\n\n<li><strong>Software Development Accreditations:&nbsp;<\/strong>ISO14971 &amp; IEC62304 accredited<\/li>\n<\/ul>\n\n\n\n<p><span style=\"text-decoration: underline;\">Supporting Services:<\/span><\/p>\n\n\n\n<p>With expert supporting services teams in&nbsp;<strong><a href=\"\/diagnostics\/supporting-services\/project-management-expertise\/\">Project Management<\/a><\/strong>,&nbsp;<strong><a href=\"\/diagnostics\/supporting-services\/data-sciences\/\">Data Sciences<\/a><\/strong>&nbsp;and&nbsp;<strong><a href=\"\/diagnostics\/supporting-services\/regulatory-and-quality-proficiency\/\">Quality &amp; Regulatory Affairs<\/a><\/strong>&nbsp;we ensure that your individual project objectives are met on time, within budget and that deliver CDx solutions that add real value.<\/p>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"wp-block-heading has-medium-font-size\"><strong><strong>CDx Experience<\/strong><\/strong><\/h4>\n\n\n\n<p>Almac has significant CDx development experience in both oncology and non-oncology settings.<\/p>\n\n\n\n<p><span style=\"text-decoration: underline;\">CDx programmes span:<\/span><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Single Site<\/strong> and <strong>IVD kit <\/strong>commercial models<\/li>\n\n\n\n<li><strong>Various Technologies<\/strong>(NGS and qPCR)<\/li>\n\n\n\n<li><strong>Differing sample types <\/strong>(blood, tumour and saliva)<\/li>\n<\/ul>\n\n\n\n<p><span style=\"text-decoration: underline;\">Biomarker programmes including the following diseases<\/span>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Multiple cancer types<\/strong><\/li>\n\n\n\n<li><strong>Ulcerative Colitis (UCD)<\/strong><\/li>\n\n\n\n<li><strong>Crohn\u2019s disease<\/strong><\/li>\n\n\n\n<li><strong>Kidney disease<\/strong><\/li>\n\n\n\n<li><strong>Liver disease<\/strong><\/li>\n\n\n\n<li><strong>COPD &amp; Asthma<\/strong><\/li>\n\n\n\n<li><strong>Neuropsychiatry<\/strong><\/li>\n<\/ul>\n\n\n\n<div style=\"height:48px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-medium-font-size\"><strong>CDx Development &amp; Validation Services \u2013 Detailed Information<\/strong><\/p>\n\n\n<!-- Accordions -->\n<section class=\"u-bg-white u-p-y4 t-theme-component-overwrite\" id=\"accordionBlock\">\n\t<div class=\"o-wrapper\">\n\t\t<div class=\"o-grid o-grid--center\">\n\t\t\t<div class=\"o-grid__item u-width-full u-align-center u-align-left@m\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t<div class=\"u-m-t2\">\n\t\t\t\t\t<div class=\"c-accordion js-accordion\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<article id=\"item1\" class=\"c-accordion__item u-c-mid-grey accordion-1\">\n\t\t\t\t\t\t        <h4 class=\"c-accordion__title u-bg-white u-c-mid-grey js-accordionTarget-one\">CDx ASSAY DEVELOPMENT &#038; VALIDATION<\/h4>\n\t\t\t\t\t\t        <div class=\"c-accordion__content u-bg-white\">\n\t\t\t\t\t\t\t\t\t<div class=\"o-grid\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<!-- if image is there then allow content to sit with it -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<!-- if not then content goes full width -->\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\"><b><img decoding=\"async\" class=\"wp-image-4320 alignright lazyload\" data-src=\"\/diagnostics\/wp-content\/uploads\/sites\/3\/2021\/11\/DX-Images_CDx-ASSAY-DEVELOPMENT-VALIDATION-.jpg\" alt=\"\" width=\"110\" height=\"143\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 110px; --smush-placeholder-aspect-ratio: 110\/143;\" \/><noscript><img decoding=\"async\" class=\" wp-image-4320 alignright\" src=\"\/diagnostics\/wp-content\/uploads\/sites\/3\/2021\/11\/DX-Images_CDx-ASSAY-DEVELOPMENT-VALIDATION-.jpg\" alt=\"\" width=\"110\" height=\"143\" \/><\/noscript><\/b><\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">Our Assay Development &amp; Validation team are responsible for the following with respect to CDx Assays<\/span><\/p>\n<ul>\n<li aria-level=\"1\"><b>Assay design via selection of assay components from approved suppliers\u00a0<\/b><\/li>\n<li aria-level=\"1\"><b>Establishment of analytical methodologies and associated QC metrics<\/b><\/li>\n<li aria-level=\"1\"><b>Formal product lock achieved under design control and risk management (QSR 820, IVDD\/IVDR and ISO13485 &amp; 14971 compliance)<\/b><\/li>\n<li aria-level=\"1\"><b>Engagement with relevant regulatory authority to outline product development plan and obtain feedback to ensure alignment<\/b><\/li>\n<li aria-level=\"1\"><b>The assay\u2019s analytical and clinical validation (performed in compliance with ISO13485, CFR 860.7 and IVDD\/IVDR, CLSI guidelines and importantly regulatory feedback obtained via pre-submission process)<\/b><\/li>\n<li aria-level=\"1\"><b>Management of design change<\/b><\/li>\n<li aria-level=\"1\"><b>Feasibility analysis, risk analysis and validation prior to regulatory submissions for approval of design change<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">All validation is performed under design control and risk management.<\/span><br \/>\n<span style=\"font-weight: 400;\">All supported by Almac\u2019s Biostatistics team who liaise and work collaboratively with the Assay Development and Validation team to establish the analysis plans, data management flow and reporting for each validation study performed.<\/span><\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/article>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<article id=\"item2\" class=\"c-accordion__item u-c-mid-grey accordion-2\">\n\t\t\t\t\t\t        <h4 class=\"c-accordion__title u-bg-white u-c-mid-grey js-accordionTarget-one\">CDx SOFTWARE<\/h4>\n\t\t\t\t\t\t        <div class=\"c-accordion__content u-bg-white\">\n\t\t\t\t\t\t\t\t\t<div class=\"o-grid\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<!-- if image is there then allow content to sit with it -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<!-- if not then content goes full width -->\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\"><img decoding=\"async\" class=\"size-full wp-image-4319 alignright lazyload\" data-src=\"\/diagnostics\/wp-content\/uploads\/sites\/3\/2021\/11\/DX-Images_CDx-SOFTWARE.jpg\" alt=\"\" width=\"148\" height=\"122\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 148px; --smush-placeholder-aspect-ratio: 148\/122;\" \/><noscript><img decoding=\"async\" class=\"size-full wp-image-4319 alignright\" src=\"\/diagnostics\/wp-content\/uploads\/sites\/3\/2021\/11\/DX-Images_CDx-SOFTWARE.jpg\" alt=\"\" width=\"148\" height=\"122\" \/><\/noscript><\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">Almac\u2019s software development team develop and validate software in compliance with IEC62304 as well as ISO14971 and QSR Part 820.30 and have supported Almac IVD programmes.<\/span><br \/>\n<span style=\"font-weight: 400;\">Almac\u2019s software team have extensive experience of engaging with the FDA to support obtaining IDE approval, pre-submissions and preparation for PMA submissions. Additionally, they are also instrumental in supporting CE-marking of clinical trial assays.<\/span><br \/>\n<span style=\"font-weight: 400;\">In terms of compliance of software processes, the following FDA guidance documents are complied with:<\/span><\/p>\n<ul>\n<li>General Principles of Software Validation<\/li>\n<li>Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices<\/li>\n<li>Off-the-Shelf Software Use in Medical Devices<\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Almac also perform cybersecurity design and risk management as practices as per the following guidance documents:<\/span><\/p>\n<ul>\n<li>Content of Premarket Submissions for Management of Cybersecurity in Medical Devices<\/li>\n<li>Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software<\/li>\n<li>The NIST\u2019s Framework for Improving Critical Infrastructure Cybersecurity<\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Finally, with respect to data integrity, data analysis and reporting software that is developed and validated will be examined with reference to the Data Integrity and Compliance with Drug CGMP Questions and Answers Guidance to Industry 2018 document. Almac ensure all system data is generated and stored in a manner to conform to ALCOA principles (attributable, legible, contemporaneous, original, accurate).<\/span><\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/article>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<article id=\"item3\" class=\"c-accordion__item u-c-mid-grey accordion-3\">\n\t\t\t\t\t\t        <h4 class=\"c-accordion__title u-bg-white u-c-mid-grey js-accordionTarget-one\">CDx MANUFACTURING<\/h4>\n\t\t\t\t\t\t        <div class=\"c-accordion__content u-bg-white\">\n\t\t\t\t\t\t\t\t\t<div class=\"o-grid\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<!-- if image is there then allow content to sit with it -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<!-- if not then content goes full width -->\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\"><img decoding=\"async\" class=\"wp-image-4318 alignright lazyload\" data-src=\"\/diagnostics\/wp-content\/uploads\/sites\/3\/2021\/11\/DX-Images_CDx-MANUFACTURING.jpg\" alt=\"\" width=\"129\" height=\"137\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 129px; --smush-placeholder-aspect-ratio: 129\/137;\" \/><noscript><img decoding=\"async\" class=\" wp-image-4318 alignright\" src=\"\/diagnostics\/wp-content\/uploads\/sites\/3\/2021\/11\/DX-Images_CDx-MANUFACTURING.jpg\" alt=\"\" width=\"129\" height=\"137\" \/><\/noscript><\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">The manufacturing team have extensive experience of engaging with the FDA to support obtaining IDE approval, pre-submissions and preparation for PMA submissions; additionally, they are also instrumental in supporting CE-marking of clinical trial assays.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Almac have a manufacturing team who have established IVD manufacturing processes which constitute current Good Manufacturing Practice (cGMP), are CFR 820 compliant and have achieved ISO13485 certification.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">These processes result in generation of the necessary evidence to ensure consistent assay component supply, adequate reagent release processes for the validation studies and a robust assay assembly, labelling, release and monitoring process for final commercialisation.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Following supplier qualification, all reagent and platform specifications are locked and agreed, and this is documented via execution of Agreements with the relevant manufacturers, with subsequent on-going monitoring of all suppliers against defined criteria.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Supplier selection and manufacturing plan will follow the guidelines laid out in GHTF\/SG3\/N17:2008 Quality Management System \u2013 Medical Devices- Guidance on the Controls of Products and Services Obtained from Suppliers.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Following selection of components and product lock, the assay system is verified, the assay is then assembled and released by Almac in accordance with ISO13485.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The ability to manufacture the assay in a commercial setting will be assessed via process validation.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Monitoring and surveillance procedures of the assay are developed to ensure continued process verification of the commercial product.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Find out more information on Almac\u2019s <\/span><a href=\"\/diagnostics\/cdx-manufacturing\/\"><b>CDx Manufacturing <\/b><\/a><b>Capabilities.<\/b><\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/article>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<\/div> <!-- \/c-tabs -->\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div> <!-- \/o-grid -->\n\t<\/div> <!-- \/o-wrapper -->\n<\/section>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-interested-in-starting-a-cdx-partnership-with-almac\">Interested in starting a CDx Partnership with Almac?  <\/h4>\n\n\n\n\n    <div class=\"u-flex u-flex-justify-start   u-m-t-auto \">\n                            <a class=\"c-btn c-btn-secondary c-btn--red\" href=\"\/diagnostics\/contact-us\/\">Get in touch<\/a>\n                    <\/div>\n\n\n\n<div style=\"height:91px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"o-wrapper\">\n\t<div class=\"o-grid\">\n\n\t\t<div class=\"o-grid__item u-width-full \">\n\t\t\t\t\t\t\t<h2 class=\"u-m-b4\">Related Resources<\/h2>\n\t\t\t\t\t<\/div>\n\n\t<\/div>\n            <div class=\"o-grid u-flex-align-stretch u-m-b3\">\n\n            \n                                            <article class=\"o-grid__item u-width-3\/12 u-width-4\/12@l u-width-6\/12@m u-width-full@s u-flex u-m-b3 u-a-full\">\n                    <div class=\"c-related-resources__panel u-flex u-flex-direction-column u-flex-align-flex-start u-p-x2 u-p-y2 u-m-b2\">\n                \n                                                <img decoding=\"async\" class=\"u-m-b2 lazyload\" data-src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/03\/NGS-Panels-\u2013-From-Patient-Selection-to-CDx-350x197-1.jpg\" alt=\"NGS Panels \u2013 From Patient Selection to CDx\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 350px; --smush-placeholder-aspect-ratio: 350\/197;\"><noscript><img decoding=\"async\" class=\"u-m-b2\" src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/03\/NGS-Panels-\u2013-From-Patient-Selection-to-CDx-350x197-1.jpg\" alt=\"NGS Panels \u2013 From Patient Selection to CDx\"><\/noscript>\n                        \n                                                    <p class=\"c-resource__category\">Webinar<\/p>\n                        \n                                                    <h4 class=\"u-m-t2\">NGS Panels \u2013 From Patient Selection to CDx<\/h4>\n                        \n                        \n                                                                                                                        <a class=\"u-m-t-auto c-btn c-btn-secondary c-btn--red\" href=\"diagnostics\/diagnostic-resource\/ngs-panels-from-patient-selection-to-cdx\/\" target=\"\">Learn more<\/a>\n                                                                                                        <\/div> <!-- \/c-related-resoucres__panel -->\n                    <\/article>\n                                            <article class=\"o-grid__item u-width-3\/12 u-width-4\/12@l u-width-6\/12@m u-width-full@s u-flex u-m-b3 u-a-full\">\n                    <div class=\"c-related-resources__panel u-flex u-flex-direction-column u-flex-align-flex-start u-p-x2 u-p-y2 u-m-b2\">\n                \n                                                <img decoding=\"async\" class=\"u-m-b2 lazyload\" data-src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2021\/04\/brexit-e1619526329631.jpg\" alt=\"The Almac Advantage \u2013 Post-Brexit Northern Ireland IVD Landscape\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 479px; --smush-placeholder-aspect-ratio: 479\/252;\"><noscript><img decoding=\"async\" class=\"u-m-b2\" src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2021\/04\/brexit-e1619526329631.jpg\" alt=\"The Almac Advantage \u2013 Post-Brexit Northern Ireland IVD Landscape\"><\/noscript>\n                        \n                                                    <p class=\"c-resource__category\">Article<\/p>\n                        \n                                                    <h4 class=\"u-m-t2\">The Almac Advantage \u2013 Post-Brexit Northern Ireland IVD Landscape<\/h4>\n                        \n                        \n                                                                                                                        <a class=\"u-m-t-auto c-btn c-btn-secondary c-btn--red\" href=\"https:\/\/www.almacgroup.com\/diagnostics\/diagnostic-resource\/the-almac-advantage-post-brexit-northern-ireland-ivd-landscape\/\" target=\"\">Learn more<\/a>\n                                                                                                        <\/div> <!-- \/c-related-resoucres__panel -->\n                    <\/article>\n                                            <article class=\"o-grid__item u-width-3\/12 u-width-4\/12@l u-width-6\/12@m u-width-full@s u-flex u-m-b3 u-a-full\">\n                    <div class=\"c-related-resources__panel u-flex u-flex-direction-column u-flex-align-flex-start u-p-x2 u-p-y2 u-m-b2\">\n                \n                                                <img decoding=\"async\" class=\"u-m-b2 lazyload\" data-src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/12\/Liquid-Biopsy-iStock-Photo-2-e1619687085988.jpg\" alt=\"The Realities of Running Next-Generation Sequencing Liquid Biopsy Panels in Clinical Trials\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 600px; --smush-placeholder-aspect-ratio: 600\/340;\"><noscript><img decoding=\"async\" class=\"u-m-b2\" src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/12\/Liquid-Biopsy-iStock-Photo-2-e1619687085988.jpg\" alt=\"The Realities of Running Next-Generation Sequencing Liquid Biopsy Panels in Clinical Trials\"><\/noscript>\n                        \n                                                    <p class=\"c-resource__category\">Webinar<\/p>\n                        \n                                                    <h4 class=\"u-m-t2\">The Realities of Running Next-Generation Sequencing Liquid Biopsy Panels in Clinical Trials<\/h4>\n                        \n                        \n                                                                                                                        <a class=\"u-m-t-auto c-btn c-btn-secondary c-btn--red\" href=\"https:\/\/www.almacgroup.com\/diagnostics\/diagnostic-resource\/the-realities-of-running-next-generation-sequencing-liquid-biopsy-panels-in-clinical-trials\/\" target=\"\">Learn more<\/a>\n                                                                                                        <\/div> <!-- \/c-related-resoucres__panel -->\n                    <\/article>\n                                            <article class=\"o-grid__item u-width-3\/12 u-width-4\/12@l u-width-6\/12@m u-width-full@s u-flex u-m-b3 u-a-full\">\n                    <div class=\"c-related-resources__panel u-flex u-flex-direction-column u-flex-align-flex-start u-p-x2 u-p-y2 u-m-b2\">\n                \n                                                <img decoding=\"async\" class=\"u-m-b2 lazyload\" data-src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/03\/NGS-Panels-\u2013-From-Patient-Selection-to-CDx-350x197-1.jpg\" alt=\"Overcoming the Challenges of Taking RNA Biomarkers into Clinical Trials\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 350px; --smush-placeholder-aspect-ratio: 350\/197;\"><noscript><img decoding=\"async\" class=\"u-m-b2\" src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/03\/NGS-Panels-\u2013-From-Patient-Selection-to-CDx-350x197-1.jpg\" alt=\"Overcoming the Challenges of Taking RNA Biomarkers into Clinical Trials\"><\/noscript>\n                        \n                                                    <p class=\"c-resource__category\">Webinar<\/p>\n                        \n                                                    <h4 class=\"u-m-t2\">Overcoming the Challenges of Taking RNA Biomarkers into Clinical Trials<\/h4>\n                        \n                        \n                                                                                                                        <a class=\"u-m-t-auto c-btn c-btn-secondary c-btn--red\" href=\"https:\/\/www.almacgroup.com\/diagnostics\/diagnostic-resource\/overcoming-the-challenges-of-taking-rna-biomarkers-into-clinical-trials\/\" target=\"\">Learn more<\/a>\n                                                                                                        <\/div> <!-- \/c-related-resoucres__panel -->\n                    <\/article>\n                    <\/div>\n    <\/div>\n","protected":false},"excerpt":{"rendered":"<p>A Collaborative CDx Partnership Approach When it comes to the discovery, development &amp; validation of companion diagnostics (CDx) for future precision medicines, no two pharmaceutical or biotech companies will ever have the same needs. At Almac Diagnostic Services, we understand these needs: timelines can be challenging, platform flexibility may be required, regulatory approaches may vary [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":8,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-16","page","type-page","status-publish","hentry"],"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 Development &amp; Validation - Diagnostic Services<\/title>\n<meta name=\"description\" content=\"CDx Development and Commercialisation - Multiplex companion diagnostics provide a proven means of capturing complex biology. 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