{"id":5371,"date":"2024-09-11T13:57:34","date_gmt":"2024-09-11T12:57:34","guid":{"rendered":"https:\/\/www.almacgroup.com\/diagnostics\/?page_id=5371"},"modified":"2025-07-01T12:11:11","modified_gmt":"2025-07-01T11:11:11","slug":"mash-masld-clinical-trial-assays","status":"publish","type":"page","link":"https:\/\/www.almacgroup.com\/diagnostics\/mash-masld-clinical-trial-assays\/","title":{"rendered":"MASH \/ MASLD Clinical Trial Assays"},"content":{"rendered":"\t<div class=\"\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t<p>Almac has developed and analytically validated qPCR genotyping CTAs from blood and buccal specimen types for both PNPLA3 and HSD17B13 genes to determine molecular eligibility for MASH \/MASLD Trials.<\/p>\n<p>The assays are designed to process up to 22 specimens per run with a turnaround time of 5-7 days from specimen receipt at Almac Diagnostic Services.<\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n\n\n\t<div class=\"\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t<h3><strong>PNPLA3 Assay Intended Use<\/strong><\/h3>\n<p>The PNPLA3 Genotyping Clinical Trial Assay (CTA) is a qualitative polymerase chain reaction (PCR) in vitro diagnostic (IVD) assay that allows identification of the I148M (rs738409) genotype within the PNPLA3 gene from DNA isolated from whole blood or buccal swabs and using the QuantStudio5\u2122 Dx instrument.<\/p>\n<p>The Assay will be used to determine the PNPLA3 genotype of subjects that are candidates for clinical trials, evaluating the clinical safety and effectiveness of investigational medicinal products for the treatment of MASH\/MASLD.<\/p>\n<p>The PNPLA3 Genotyping CTA is intended for investigational use only, with testing to be performed at Almac Diagnostic Services\u2019 Clinical Laboratory Improvement Amendments (CLIA) \/ College of American Pathologists (CAP) accredited laboratories located at 19 Seagoe Industrial Estate, Craigavon, BT63 5QD, UK and 4238 Technology Drive, Durham, NC, USA.<\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n\n\n\t<div class=\"\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t<h3><strong>HSD17B13 Assay Intended Use<\/strong><\/h3>\n<p>The HSD17B13 Genotyping Clinical Trial Assay (CTA) is a qualitative polymerase chain reaction (PCR) in vitro diagnostic (IVD) assay that allows allelic discrimination of rs72613567 (Adenine insertion) within the HSD17B13 gene from DNA derived from whole blood or buccal swabs using the QuantStudio5\u2122 Dx instrument.<\/p>\n<p>The Assay will be used to determine the HSD17B13 genotype of subjects that are candidates for clinical trials, evaluating the clinical safety and effectiveness of investigational medicinal products for the treatment of MASH\/MASLD.<\/p>\n<p>The HSD17B13 Genotyping CTA is intended for investigational use only, with testing to be performed at Almac Diagnostic Services\u2019 Clinical Laboratory Improvement Amendments (CLIA) \/ College of American Pathologists (CAP) accredited laboratories located at 19 Seagoe Industrial Estate, Craigavon, BT63 5QD, UK and 4238 Technology Drive, Durham, NC, US.<\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\t<div class=\"\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t<h3><strong>Level of Analytical Validation &amp; Compliance<\/strong><\/h3>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n\n\n\t<div class=\"\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t<p><img decoding=\"async\" class=\"alignnone wp-image-5444 size-full lazyload\" data-src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/09\/Level-of-Analytical-Validation-Compliance.png\" alt=\"\" width=\"602\" height=\"155\" data-srcset=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/09\/Level-of-Analytical-Validation-Compliance.png 602w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/09\/Level-of-Analytical-Validation-Compliance-300x77.png 300w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/09\/Level-of-Analytical-Validation-Compliance-480x124.png 480w\" data-sizes=\"(max-width: 602px) 100vw, 602px\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 602px; --smush-placeholder-aspect-ratio: 602\/155;\" \/><noscript><img decoding=\"async\" class=\"alignnone wp-image-5444 size-full\" src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/09\/Level-of-Analytical-Validation-Compliance.png\" alt=\"\" width=\"602\" height=\"155\" srcset=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/09\/Level-of-Analytical-Validation-Compliance.png 602w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/09\/Level-of-Analytical-Validation-Compliance-300x77.png 300w, https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2024\/09\/Level-of-Analytical-Validation-Compliance-480x124.png 480w\" sizes=\"(max-width: 602px) 100vw, 602px\" \/><\/noscript><\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\t<div class=\"\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t<h3><strong>Key Benefits<\/strong><\/h3>\n<ul>\n<li>High Accuracy, Sensitivity, Specificity &amp; Reproducibility (100%)<\/li>\n<li>EU &amp; US Regulation Compliant for Clinical Trial Use<\/li>\n<li>Delivered from Almac Global Accredited Labs (CLIA \/ CAP \/ ISO15189)<\/li>\n<\/ul>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\t<div class=\"\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t<p><span style=\"color: #ff0000;\"><strong>DOWNLOAD ALMAC ASSAY FACT SHEETS<\/strong><\/span><\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\t<div class=\"\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t<section class=\"o-grid o-grid--fill\">\n<div class=\"o-grid__item u-width-4\/12 u-width-full@s u-m-b3@s\">\n<p class=\"u-block u-m-b3\"><a href=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/07\/90140_ALMAC_DS_PNPLA3_CTA_Factsheet_D1.pdf\">Download Fact Sheet<\/a><\/p>\n<p><a href=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/07\/90140_ALMAC_DS_PNPLA3_CTA_Factsheet_D1.pdf\"><img decoding=\"async\" class=\"alignnone wp-image-5544 size-medium lazyload\" data-src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/07\/PNP-Kit-Fact-Sheet-Cover_2025.png\" alt=\"\" width=\"212\" height=\"300\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 212px; --smush-placeholder-aspect-ratio: 212\/300;\" \/><noscript><img decoding=\"async\" class=\"alignnone wp-image-5544 size-medium\" src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/07\/PNP-Kit-Fact-Sheet-Cover_2025.png\" alt=\"\" width=\"212\" height=\"300\" \/><\/noscript><\/a><\/p>\n<\/div>\n<div class=\"o-grid__item u-width-4\/12 u-width-full@s u-m-b3@s\">\n<p class=\"u-block u-m-b3\"><a href=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/07\/90140_ALMAC_DS_HSD17B13_CTA_Factsheet_D1.pdf\">Download Fact Sheet<\/a><\/p>\n<p><a href=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/07\/90140_ALMAC_DS_HSD17B13_CTA_Factsheet_D1.pdf\"><img decoding=\"async\" class=\"alignnone size-medium wp-image-5553 lazyload\" data-src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/07\/HSD-Genotyping-kit-Fact-Sheet_Cover_2025.png\" alt=\"\" width=\"212\" height=\"300\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" style=\"--smush-placeholder-width: 212px; --smush-placeholder-aspect-ratio: 212\/300;\" \/><noscript><img decoding=\"async\" class=\"alignnone size-medium wp-image-5553\" src=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2025\/07\/HSD-Genotyping-kit-Fact-Sheet_Cover_2025.png\" alt=\"\" width=\"212\" height=\"300\" \/><\/noscript><\/a><\/p>\n<\/div>\n<\/section>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\t<div class=\"\">\n\t\t<div class=\"o-wrapper\">\n\t\t\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t<p><script charset=\"utf-8\" type=\"text\/javascript\" src=\"\/\/js.hsforms.net\/forms\/embed\/v2.js\"><span data-mce-type=\"bookmark\" style=\"display: inline-block; width: 0px; overflow: hidden; line-height: 0;\" class=\"mce_SELRES_start\">\ufeff<\/span><\/script><br \/>\n<script>\nhbspt.forms.create({\nregion: \"na1\",\nportalId: \"742105\",\nformId: \"0133ec69-b8a0-4ef4-9c2e-2b8411b4c699\"\n});\n<\/script><\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":824,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-5371","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>MASH \/ MASLD Clinical Trial Assays - Diagnostic Services<\/title>\n<meta name=\"description\" content=\"Advance your MASH and MAFLD trials with Almac&#039;s specialised assays. 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