{"id":14,"date":"2020-01-22T09:49:49","date_gmt":"2020-01-22T09:49:49","guid":{"rendered":"https:\/\/www.almacgroup.com\/diagnostics\/?page_id=14"},"modified":"2025-12-02T15:04:31","modified_gmt":"2025-12-02T15:04:31","slug":"clinical-trial-assay-development","status":"publish","type":"page","link":"https:\/\/www.almacgroup.com\/diagnostics\/clinical-trial-solutions\/clinical-trial-assay-development\/","title":{"rendered":"Custom Assay Development"},"content":{"rendered":"\n<p class=\"has-large-font-size\">Custom Assay Development<\/p>\n\n\n\n<div style=\"height:35px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p id=\"block-b3babc5c-628f-4ad1-a9fb-16aa8974b3c6\">Almac Diagnostic Services&nbsp;offer a complete custom assay development and validation service that can develop assays across the continuum from RUO to IUO to CDx depending on client biomarker programme needs.<\/p>\n\n\n\n<p id=\"block-5333b97c-e25b-4fe7-8d87-cad055bd3ab1\">Almac Diagnostic Services\u2019 Product Development team supports development and validation of Almac and Third Party products, whether custom-made or off-the-shelf solutions, for exploratory, investigational and commercial use.<\/p>\n\n\n\n<p id=\"block-5333b97c-e25b-4fe7-8d87-cad055bd3ab1\">As assays progress from research assays towards assays for use in clinical trial stratification the assay level of complexity increases, as does the stringent validation requirements, regulatory requirements and reporting.<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-medium-font-size\" id=\"h-assay-development-roadmap\"><strong>Assay Development Roadmap<\/strong><\/h2>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"346\" data-src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/02\/Custom-Assay-Development-Roadmap-Image-1024x346.png\" alt=\"\" class=\"wp-image-5827 lazyload\" data-srcset=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/02\/Custom-Assay-Development-Roadmap-Image-1024x346.png 1024w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/02\/Custom-Assay-Development-Roadmap-Image-300x101.png 300w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/02\/Custom-Assay-Development-Roadmap-Image-768x259.png 768w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/02\/Custom-Assay-Development-Roadmap-Image-480x162.png 480w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/02\/Custom-Assay-Development-Roadmap-Image.png 1274w\" data-sizes=\"(max-width: 1024px) 100vw, 1024px\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 1024px; --smush-placeholder-aspect-ratio: 1024\/346;\" \/><noscript><img decoding=\"async\" width=\"1024\" height=\"346\" src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/02\/Custom-Assay-Development-Roadmap-Image-1024x346.png\" alt=\"\" class=\"wp-image-5827\" srcset=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/02\/Custom-Assay-Development-Roadmap-Image-1024x346.png 1024w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/02\/Custom-Assay-Development-Roadmap-Image-300x101.png 300w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/02\/Custom-Assay-Development-Roadmap-Image-768x259.png 768w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/02\/Custom-Assay-Development-Roadmap-Image-480x162.png 480w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/02\/Custom-Assay-Development-Roadmap-Image.png 1274w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/noscript><\/figure>\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\" id=\"block-6bf688f7-e23a-41fb-8f95-e0125511f6d6\"><strong>Assay Development<\/strong><\/h4>\n\n\n\n<p id=\"block-15e217eb-2b18-4154-8333-b8dcd8ab2b03\">Almac Diagnostic Services has extensive experience in the development and delivery of RNA &amp; DNA based <strong>Research Use Only (RUO) assays<\/strong>, generating high quality data for clients.<\/p>\n\n\n\n<p id=\"block-ae17f462-746e-4f9b-aa1f-e724f00c9498\">We work from <strong>multiple sample types<\/strong> (FFPE, Fresh Frozen, Blood and Others) and offer clients complete flexibility to be able to run assays on a <strong>wide range of platforms<\/strong> including IHC, NGS, qPCR and ddPCR technologies as well as nanoString.<\/p>\n\n\n\n<p id=\"block-9ca3ee41-7d5b-4dd2-a08c-5b9e72b0ff95\">More details on the platforms we offer &amp; our quality and accreditation systems can be found in our&nbsp;<strong><a href=\"\/diagnostics\/platforms-technologies\/\">Platforms &amp; Technologies<\/a><\/strong>&nbsp;and&nbsp;<strong><a href=\"\/diagnostics\/supporting-services\/global-laboratories\/quality-management-system-qms\/\">Quality Management System (QMS)<\/a><\/strong>&nbsp;sections.<\/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\" id=\"block-4e591969-e0cf-4e21-b37e-e8773810ed28\"><strong>Assay Validation<\/strong><\/h4>\n\n\n\n<p id=\"block-c91ce1af-836e-480c-854f-8a3ba2c11017\">The process of developing a discovered biomarker into a test suitable for clinical delivery is complex, but it is an area in which Almac has significant experience.<\/p>\n\n\n\n<p id=\"block-ed643e7a-35df-4224-8676-87a9635d67f1\">Almac can develop biomarkers into tests for clinical delivery on a range of multiple platforms. We develop, validate and run <strong>Investigational Use Only (IUO)<\/strong> assays as part of the clinical trial process where some ultimately progress towards <strong><a href=\"\/diagnostics\/companion-diagnostics\/\">Companion Diagnostic (CDx)<\/a> <\/strong>assays for commercial launch.<\/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\" id=\"h-almac-pd-biomarker-testing-service\"><strong><strong>Almac PD Biomarker Testing Service<\/strong><\/strong><\/h4>\n\n\n\n<p>Almac Diagnostic Services can also help Biopharma clients<strong>&nbsp;validate reliable PD assays<\/strong>&nbsp;that can help provide invaluable guidance within their drug development programmes.<\/p>\n\n\n\n<p>Almac can develop and perform PD testing on&nbsp;<a href=\"https:\/\/www.almacgroup.com\/diagnostics\/supporting-services\/platforms-technologies\/\"><strong>multiple technology platforms<\/strong><\/a>&nbsp;across&nbsp;<strong>multiple sample types<\/strong>&nbsp;for&nbsp;<strong>qPCR<\/strong>&nbsp;and Next Generation Sequencing&nbsp;<strong>(NGS)<\/strong>&nbsp;from our global CLIA and CAP-accredited <a href=\"https:\/\/www.almacgroup.com\/diagnostics\/supporting-services\/global-laboratories\/\"><strong>labs<\/strong><\/a>.<\/p>\n\n\n\n\n    <div class=\"u-flex u-flex-justify-start   u-m-t-auto \">\n                            <a class=\"c-btn c-btn-primary c-btn--red\" href=\"\/diagnostics\/clinical-trial-solutions\/pharmacodynamic-biomarker-testing\/\">Find out more<\/a>\n                    <\/div>\n\n\n\n<div style=\"height:48px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"wp-block-heading has-medium-font-size\" id=\"block-b9252bec-7a0d-4fa5-a01c-89c40c75d6e5\"><strong>Our Range of Services<\/strong><\/h4>\n\n\n\n<ul id=\"block-53a483d0-cd32-4669-96f8-34ecabbbc89d\" class=\"wp-block-list\">\n<li>Determining the Optimal Platform for Assay Delivery<\/li>\n\n\n\n<li>Assay Design, Platform Selection &amp; Migration<\/li>\n\n\n\n<li>Almac Proprietary panel of qPCR reference genes<\/li>\n\n\n\n<li>Assay Transfer &amp; Validation for clinical delivery<\/li>\n\n\n\n<li>Control Gene Selection<\/li>\n\n\n\n<li>Analytical Validation of the assay to CLIA, CLEP, CE-IVD and FDA standards&nbsp;<\/li>\n\n\n\n<li>Developing the assay instructions for use (IFU)&nbsp;<\/li>\n\n\n\n<li>Generating appropriate Reference Samples for validation or clinical delivery<\/li>\n\n\n\n<li>Software (Verified and tested) to automate the production of test reports from raw test data&nbsp;<\/li>\n\n\n\n<li>Test interface and Reporting<\/li>\n\n\n\n<li>Phase I, II and III Clinical Trial Testing<\/li>\n<\/ul>\n\n\n\n<div style=\"height:48px\" 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\/EORTC1.jpg\" alt=\"\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 350px; --smush-placeholder-aspect-ratio: 350\/200;\"><noscript><img decoding=\"async\" class=\"u-m-b2\" src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/03\/EORTC1.jpg\" alt=\"\"><\/noscript>\n                        \n                                                    <p class=\"c-resource__category\">News<\/p>\n                        \n                        \n                                                    <p class=\"u-m-y2 u-text-small ie-block-height\">Almac Diagnostic Services and EORTC Establish Collaboration for Tumour Molecular Profiling<\/p>\n                        \n                                                                                                                        <a class=\"u-m-t-auto c-btn c-btn-secondary c-btn--red\" href=\"\/news\/almac-diagnostics-eortc-establish-collaboration-tumour-molecular-profiling\/\" 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=\"\" 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=\"\"><\/noscript>\n                        \n                                                    <p class=\"c-resource__category\">Webinar<\/p>\n                        \n                        \n                                                    <p class=\"u-m-y2 u-text-small ie-block-height\">NGS Panels \u2013 From Patient Selection to CDx<\/p>\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\/2020\/03\/Developing-and-Applying-Biomarkers-in-Early-Phase-Clinical-Trials-PNG-350x197-1.png\" alt=\"\" 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\/Developing-and-Applying-Biomarkers-in-Early-Phase-Clinical-Trials-PNG-350x197-1.png\" alt=\"\"><\/noscript>\n                        \n                                                    <p class=\"c-resource__category\">Webinar<\/p>\n                        \n                        \n                                                    <p class=\"u-m-y2 u-text-small ie-block-height\">Developing and Applying Biomarkers in Early Phase Clinical Trials<\/p>\n                        \n                                                                                                                        <a class=\"u-m-t-auto c-btn c-btn-secondary c-btn--red\" href=\"\/diagnostics\/diagnostic-resource\/developing-and-applying-biomarkers-in-early-phase-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\/Next-Generation-Sequencing-in-Companion-Diagnostic-Development-350x197-1.png\" alt=\"\" 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\/Next-Generation-Sequencing-in-Companion-Diagnostic-Development-350x197-1.png\" alt=\"\"><\/noscript>\n                        \n                                                    <p class=\"c-resource__category\">Webinar<\/p>\n                        \n                        \n                                                    <p class=\"u-m-y2 u-text-small ie-block-height\">Next Generation Sequencing in Companion Diagnostic Development\r\n\r\n<\/p>\n                        \n                                                                                                                        <a class=\"u-m-t-auto c-btn c-btn-secondary c-btn--red\" href=\"diagnostics\/diagnostic-resource\/next-generation-sequencing-in-companion-diagnostic-development\/\" target=\"\">Learn more<\/a>\n                                                                                                        <\/div> <!-- \/c-related-resoucres__panel -->\n                    <\/article>\n                    <\/div>\n    <\/div>\n","protected":false},"excerpt":{"rendered":"<p>Custom Assay Development Almac Diagnostic Services&nbsp;offer a complete custom assay development and validation service that can develop assays across the continuum from RUO to IUO to CDx depending on client biomarker programme needs. Almac Diagnostic Services\u2019 Product Development team supports development and validation of Almac and Third Party products, whether custom-made or off-the-shelf solutions, for [&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-14","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>Custom Assay Development - Diagnostic Services<\/title>\n<meta name=\"description\" content=\"Clinical Trial Assay Development - Extensive expertise in the development of CLIA validated clinical trial assays. 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