{"id":2361,"date":"2025-02-01T22:02:48","date_gmt":"2025-02-01T22:02:48","guid":{"rendered":"https:\/\/www.nordicbioscience.com\/?page_id=2361"},"modified":"2025-06-01T15:16:44","modified_gmt":"2025-06-01T15:16:44","slug":"ecm-biomarkers-in-the-best-framework","status":"publish","type":"page","link":"https:\/\/www.nordicbioscience.com\/why-biomarkers\/ecm-biomarkers-in-the-best-framework\/","title":{"rendered":"ECM Biomarkers In The BEST Framework"},"content":{"rendered":"<section class=\"title-block\">\n    <div class=\"inner xl:p-10 lg:p-8 lg:pb-0 xl:pb-0 p-5 pb-0 max-w-[1440px] mx-auto\">\n        <div class=\"breadcrumbs\">\n            <ul class=\"flex text-body-sm text-blue\">\n                <li class=\"flex items-center after:mx-[5px] after:content-[''] after:my-auto after:inline-block after:w-1 after:h-1 after:rounded-full after:bg-gray-400 after:aspect-square\">\n                    <a class=\"py-1 opacity-75 xl:hover:opacity-100 truncate max-w-40\" href=\"https:\/\/www.nordicbioscience.com\">Home<\/a>\n                <\/li>\n                <li class=\"flex items-center after:mx-[5px] after:content-[''] after:my-auto after:inline-block after:w-1 after:h-1 after:rounded-full after:bg-gray-400 after:aspect-square\">\n                                <a class=\"opacity-75 xl:hover:opacity-100 truncate max-w-40\" href=\"https:\/\/www.nordicbioscience.com\/why-biomarkers\/\">Why Biomarkers?<\/a>\n                              <\/li>                <li class=\"flex items-center truncate max-w-40\"> \n                    \n                    <p class=\"\"class=\"py-1\">\n                    ECM Biomarkers In The BEST Framework                    <\/p>\n                <\/li>\n            <\/ul>\n        <\/div>\n        <h1 class=\"font-bold text-navy text-m-title-lg xl:text-d-title-lg\">ECM Biomarkers In The BEST Framework<\/h1>\n            <\/div>\n<\/section>\n\n\n<section class=\"two-column group white bg-white\">\n        <!-- \n        initialize dynamic classes\n        bg-grey\n        bg-dark\n        lg:flex-row-reverse\n        lg:flex-row\n        -->\n   <div class=\"inner items-center lg:p-8 xl:p-10 p-5 max-w-[1440px] mx-auto flex gap-4 lg:gap-8 xl:gap-10 flex-col lg:flex-row\">\n        <article class=\"flex flex-col justify-between flex-1 text-column lg:py-8 xl:py-10\">\n            <div class=\"\">\n                <div>\n                                    <h2 class=\"mb-4 font-bold xl:mb-8 title text-m-title-lg xl:text-d-title-md group-[.white]:text-navy group-[.grey]:text-navy group-[.dark]:text-fontlight\">Biomarkers of ECM remodeling<\/h2>\n                 \n\n                <\/div>\n                <div class=\"wysiwyg mb-8 xl:mb-0 body-text group-[.white]:text-blue group-[.grey]:text-blue group-[.dark]:text-fontlightbody\">\n                    <p>Extracellular matrix (ECM) turnover and homeostasis is becoming increasingly acknowledged as a pathological factor affected by fibro-inflammatory diseases. This process is involved in multiple different disease indications, including those affecting the liver, kidneys, heart, and lungs. Because of this increasingly clear association to many different pathologies, biomarkers reflecting tissue destruction and fibrosis can be implemented across disease indications to help guide drug development and clinical trial evaluation.<\/p>\n<p>Novel treatments are being investigated for their effect on ECM remodeling, calling in turn for novel biomarkers to reflect this impact; such biomarkers may reveal novel drug targets and help separate pathological pathways. An essential fact of drug development is that biomarkers of ECM remodeling provide tools for evaluating changes to the ground substance in the organs. This is because collagens and other ECM proteins make up the main bulk of organs.<\/p>\n<p>In fact, more than 50 different diseases are associated with changes in the tissues of organs, tissue formation or degradation, leading to tissue changes that affect tissue function. For example, dysregulated tissue homeostasis is a common feature associated with fibro-inflammatory diseases. It is implicated as both a cause and consequence of disease and outcome, is associated with up to 35% of deaths in the western world and is projected to increase. To be truly efficacious, and not just symptomatic, drug developers should also focus on treatments that affect the organs and reverse the organ damage conflicted in the ECM.<\/p>\n                <\/div>\n                                <\/div>\n                        <\/article>\n        <figure class=\"flex-1 rounded-md -order-1 xl:order-none  xl:rounded-xl overflow-clip media-column shadow-main\">\n            <img decoding=\"async\" class=\"object-cover min-h-full aspect-square\" src=\"https:\/\/www.nordicbioscience.com\/wp-content\/uploads\/2025\/01\/shutterstock_1470753386-scaled.webp\" alt=\"\">\n        <\/figure>   \n    <\/div>\n<\/section>\n\n\n\n<section class=\"two-column-text group  bg-\">\n   <div class=\"inner lg:p-8 xl:p-10 p-5 max-w-[1440px] mx-auto flex gap-4 lg:flex-row lg:gap-8 xl:gap-10 flex-col\">\n        <div class=\"w-full left-column lg:w-1\/2 xl:w-1\/2 wysiwyg\">\n             <p><!-- wp:image {\"lightbox\":{\"enabled\":true},\"id\":2367,\"sizeSlug\":\"large\",\"linkDestination\":\"none\",\"align\":\"center\"} --><\/p>\n<figure class=\"wp-block-image aligncenter size-large\"><a href=\"https:\/\/www.nordicbioscience.com\/wp-content\/uploads\/2025\/02\/tissue-turnover-quantification-nordic-bioscience-scaled.webp\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-2367 size-full\" src=\"https:\/\/www.nordicbioscience.com\/wp-content\/uploads\/2025\/02\/tissue-turnover-quantification-nordic-bioscience-scaled.webp\" alt=\"\" width=\"2560\" height=\"1739\" srcset=\"https:\/\/www.nordicbioscience.com\/wp-content\/uploads\/2025\/02\/tissue-turnover-quantification-nordic-bioscience-scaled.webp 2560w, https:\/\/www.nordicbioscience.com\/wp-content\/uploads\/2025\/02\/tissue-turnover-quantification-nordic-bioscience-300x204.webp 300w, https:\/\/www.nordicbioscience.com\/wp-content\/uploads\/2025\/02\/tissue-turnover-quantification-nordic-bioscience-1024x696.webp 1024w, https:\/\/www.nordicbioscience.com\/wp-content\/uploads\/2025\/02\/tissue-turnover-quantification-nordic-bioscience-768x522.webp 768w, https:\/\/www.nordicbioscience.com\/wp-content\/uploads\/2025\/02\/tissue-turnover-quantification-nordic-bioscience-1536x1043.webp 1536w, https:\/\/www.nordicbioscience.com\/wp-content\/uploads\/2025\/02\/tissue-turnover-quantification-nordic-bioscience-2048x1391.webp 2048w\" sizes=\"auto, (max-width: 2560px) 100vw, 2560px\" \/><\/a><figcaption class=\"wp-element-caption\"><em><strong>Figure 1.<\/strong>\u00a0Quantifying pathological tissue turnover distinguished from healthy tissue turnover.<\/em><\/figcaption><\/figure>\n<p><!-- \/wp:image --><\/p>\n        <\/div>\n        <div class=\"w-full right-column lg:w-1\/2 xl:w-1\/2 wysiwyg\">\n             <p>During normal tissue homeostasis, there is a balance between tissue formation and degradation, necessary to preserve tissue function.<\/p>\n<p>In disease affected tissue the balance is distorted, which can lead to impaired tissue- and organ function.<\/p>\n<p>These processes can be quantified by biomarkers reflecting ECM turnover, but advanced assays measuring specific neo-epitopes are needed which accurately quantify both tissue formation and degradation, in order to quantify the balance.<\/p>\n<p>The process of tissue formation and degradation is constantly ongoing but turns pathological when deposition of newly formed proteins exceeds the degradation or vice versa. These tissue changes can be monitored non-invasively in blood tests, however, it is important to know exactly what the applied biomarkers reflect. Specific neo-epitope generated biomarkers serve as a more accurate measure of ongoing tissue modulation as compared to epitopes that are generically generated, which impacts the information and utility that can be derived thereof (figure 1).<\/p>\n        <\/div>   \n    <\/div>\n<\/section>\n\n\n\n<section class=\"two-column-text group  bg-\">\n   <div class=\"inner lg:p-8 xl:p-10 p-5 max-w-[1440px] mx-auto flex gap-4 lg:flex-row lg:gap-8 xl:gap-10 flex-col\">\n        <div class=\"w-full left-column lg:w-1\/2 xl:w-1\/2 wysiwyg\">\n             <div class=\"page-header page-header-custom-default\">\n<h2 class=\"block-fc\">ECM biomarkers and the FDA\u2019s BEST framework<\/h2>\n<\/div>\n<p>The major constituent of the ECM is collagen. Currently, 28 different types of collagens are known. Each of these collagens give rise to unique epitopes being released during formation and degradation, and these epitopes can be targeted as non-invasive biomarkers to provide insight in tissue turnover, which have the potential of assisting and guiding drug development in several aspects (table 2). These collagens are found in almost all tissues throughout the body but exhibit different expression patterns in diseases.<\/p>\n<p>As a result, the epitopes derived during formation and degradation can provide specific insight in pathological tissue turnover, which can facilitate increased understanding of disease status and progression, and risk of outcome. Therapeutic intervention targeting ECM turnover aiming at restoring tissue homeostasis will have an impact on the serological concentration of ECM epitopes, thus, to develop and market truly efficacious treatments targeting these processes, novel biomarkers are needed.<\/p>\n        <\/div>\n        <div class=\"w-full right-column lg:w-1\/2 xl:w-1\/2 wysiwyg\">\n             <p><!-- wp:image {\"lightbox\":{\"enabled\":false},\"id\":2385,\"sizeSlug\":\"large\",\"linkDestination\":\"custom\",\"align\":\"center\"} --><\/p>\n<figure class=\"wp-block-image aligncenter size-large\"><a href=\"https:\/\/www.nordicbioscience.com\/wp-content\/uploads\/2025\/02\/best-nomenclature-applied-to-ecm-biomarkers-nordic-bioscience-scaled.webp\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-2385 size-full\" src=\"https:\/\/www.nordicbioscience.com\/wp-content\/uploads\/2025\/02\/best-nomenclature-applied-to-ecm-biomarkers-nordic-bioscience-scaled.webp\" alt=\"\" width=\"2560\" height=\"1198\" srcset=\"https:\/\/www.nordicbioscience.com\/wp-content\/uploads\/2025\/02\/best-nomenclature-applied-to-ecm-biomarkers-nordic-bioscience-scaled.webp 2560w, https:\/\/www.nordicbioscience.com\/wp-content\/uploads\/2025\/02\/best-nomenclature-applied-to-ecm-biomarkers-nordic-bioscience-300x140.webp 300w, https:\/\/www.nordicbioscience.com\/wp-content\/uploads\/2025\/02\/best-nomenclature-applied-to-ecm-biomarkers-nordic-bioscience-1024x479.webp 1024w, https:\/\/www.nordicbioscience.com\/wp-content\/uploads\/2025\/02\/best-nomenclature-applied-to-ecm-biomarkers-nordic-bioscience-768x360.webp 768w, https:\/\/www.nordicbioscience.com\/wp-content\/uploads\/2025\/02\/best-nomenclature-applied-to-ecm-biomarkers-nordic-bioscience-1536x719.webp 1536w, https:\/\/www.nordicbioscience.com\/wp-content\/uploads\/2025\/02\/best-nomenclature-applied-to-ecm-biomarkers-nordic-bioscience-2048x959.webp 2048w\" sizes=\"auto, (max-width: 2560px) 100vw, 2560px\" \/><\/a><figcaption class=\"wp-element-caption\"><em><strong>Table 1.<\/strong>\u00a0BEST nomenclature applied to ECM biomarkers. Given the ability of ECM biomarkers to accurately reflect ongoing tissue remodeling, they can potentially be used and applied according to several of the\u00a0<a href=\"https:\/\/www.nordicbioscience.com\/fda-biomarker-guidelines-best\/\" data-type=\"page\" data-id=\"2354\">BEST classification criteria<\/a>.<\/em><\/figcaption><!-- \/wp:image --><\/figure>\n        <\/div>   \n    <\/div>\n<\/section>\n\n\n<section class=\"two-column group white bg-white\">\n        <!-- \n        initialize dynamic classes\n        bg-greybg\n        bg-dark\n        xl:flex-row-reverse\n        xl:flex-row\n        -->\n   <div class=\"inner xl:p-10 lg:p-8 p-5 max-w-[1440px] mx-auto flex gap-4 xl:gap-10 flex-col xl:flex-row-reverse\">\n        <article class=\"flex flex-col justify-between flex-1 text-column\">\n            <div class=\"\">\n                <div>\n                                    <h2 class=\"mb-4 font-bold xl:mb-8 title text-m-title-lg xl:text-d-title-lg group-[.white]:text-navy 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