{"id":1635,"date":"2025-01-30T09:34:03","date_gmt":"2025-01-30T09:34:03","guid":{"rendered":"https:\/\/www.nordicbioscience.com\/?page_id=1635"},"modified":"2025-06-06T08:34:03","modified_gmt":"2025-06-06T08:34:03","slug":"regulatory-services-and-biomarker-validation","status":"publish","type":"page","link":"https:\/\/www.nordicbioscience.com\/laboratory-services\/regulatory-services-and-biomarker-validation\/","title":{"rendered":"Regulatory Services and Biomarker Validation"},"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\/laboratory-services\/\">Laboratory Services<\/a>\n                              <\/li>                <li class=\"flex items-center truncate max-w-40\"> \n                    \n                    <p class=\"\"class=\"py-1\">\n                    Regulatory Services and Biomarker Validation                    <\/p>\n                <\/li>\n            <\/ul>\n        <\/div>\n        <h1 class=\"font-bold text-navy text-m-title-lg xl:text-d-title-lg\">Regulatory Services and Biomarker Validation<\/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\">Hurdles of biochemical assay validation<\/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>According to the FDA, a biomarker is a\u00a0<em>&#8220;defined characteristic measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions.&#8221;<\/em><\/p>\n<p>Biomarkers enrich clinical research, but it is critical that communication from the generation of an idea to the development of a cure be transparent. Unfortunately, confusion prevails due to inadequate terminology, which hinders the effective use and clinical relevance of biomarkers.<\/p>\n<p>Only a limited number of compounds are approved as drugs, despite the countless compounds that go through the time-consuming and costly clinical development phases, not to mention the issues of demonstrable efficacy or safety. If such a drug candidate fails at a later stage, the investment losses are devastating.<\/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\/05\/nordic_bio32466.jpg\" alt=\"\">\n        <\/figure>   \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-reverse\">\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\">The validation process <\/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>The validation of a biomarker is a lengthy regulatory, technical, and clinical process. Validation requirements are further complicated by regional differences. Both the FDA and the EU require clinical validation according to\u00a0protocols and standards of the Clinical and Laboratory Standards Institute (CLSI), which provide guidelines for the highest quality assays, and both regions require two studies conducted under Good Clinical Practice (GCP). Technical validation is tied to CLSI protocols by the FDA. At the same time, the EU requires validation according to the\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-bioanalytical-method-validation_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">EMA guidelines on validation of bioanalytical methods<\/a>.<\/p>\n<p>For the FDA,\u00a0biomarker validation\u00a0is a\u00a0<a href=\"https:\/\/www.fda.gov\/drugs\/biomarker-qualification-program\/about-biomarkers-and-qualification#How_are_biomarkers_qualified_for_drug_development_\" target=\"_blank\" rel=\"noopener noreferrer\">three-stage process<\/a>\u00a0that begins with a Letter of Intent that initiates the qualification process for the context of use in drug development. The second stage includes a Qualification Plan that defines the intended development of supporting qualification data. The final stage involves all of the data collected to support the qualification of the biomarker, known as the Full Qualification Package. Once qualified, the biomarker receives a recommendation from the FDA based on a comprehensive review.<\/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\/05\/nordic_bio32265.jpg\" alt=\"\">\n        <\/figure>   \n    <\/div>\n<\/section>\n\n\n\n<div style=\"height:var(--wp--preset--spacing--50)\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\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\">Translational tools in the regulatory field<\/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>Translational tools such as blood-based biomarkers can provide important information about efficacy, safety, mode of action, and response to treatment in drug development. However, many of these biomarkers lack tissue specificity, leaving gaps between disease pathology and cellular origin, making these markers not fully translatable and pharmacodynamically modulable.<\/p>\n<p>Collagen fragments, however, released into the bloodstream during protein formation and degradation, reflect tissue-specific turnover. Changes in tissue turnover can be quantified and used in preclinical and clinical research. This\u00a0<a href=\"https:\/\/www.nordicbioscience.com\/technology\/nordic-proteinfingerprint-technology\/\">Protein Fingerprint technology\u00a0<\/a>enables more accurate measurement of pharmacodynamic modulation and supports the development of drug candidates at every clinical stage.<\/p>\n<p>Nordic Bioscience has developed FDA-approved biomarkers, CTX-I, a marker of bone resorption, and osteocalcin, a marker of bone formation. A third biomarker, <a href=\"https:\/\/www.nordicbioscience.com\/biomarker-portfolio\/pro-c6\/\">PRO-C6<\/a>, which measures the\u00a0<a href=\"https:\/\/www.nordicbioscience.com\/endotrophin-as-a-novel-biomarker-in-hfpef-identification-of-a-high-risk-endotype\/\">adverse effects endotrophin in Heart Failure with preserved Ejection Fraction (HFpEF)<\/a>, recently received a\u00a0<a href=\"https:\/\/www.nordicbioscience.com\/about\/news-events\/endotrophin-pro-c6-letter-of-support-by-fda\" target=\"_blank\" rel=\"noopener noreferrer\">Letter of Support<\/a>\u00a0from the FDA.<\/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\/05\/nordic_bio32285.jpg\" alt=\"\">\n        <\/figure>   \n    <\/div>\n<\/section>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"579\" src=\"https:\/\/www.nordicbioscience.com\/wp-content\/uploads\/2025\/01\/steps-of-biochemical-assay-validation-webp-1024x579.webp\" alt=\"\" class=\"wp-image-1650\" srcset=\"https:\/\/www.nordicbioscience.com\/wp-content\/uploads\/2025\/01\/steps-of-biochemical-assay-validation-webp-1024x579.webp 1024w, https:\/\/www.nordicbioscience.com\/wp-content\/uploads\/2025\/01\/steps-of-biochemical-assay-validation-webp-300x169.webp 300w, https:\/\/www.nordicbioscience.com\/wp-content\/uploads\/2025\/01\/steps-of-biochemical-assay-validation-webp-768x434.webp 768w, https:\/\/www.nordicbioscience.com\/wp-content\/uploads\/2025\/01\/steps-of-biochemical-assay-validation-webp-1536x868.webp 1536w, https:\/\/www.nordicbioscience.com\/wp-content\/uploads\/2025\/01\/steps-of-biochemical-assay-validation-webp.webp 1855w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><figcaption class=\"wp-element-caption\"><em>The steps of biochemical assay validation following the FDA and EMA guideline<\/em><\/figcaption><\/figure><\/div>\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-reverse\">\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\">FDA and NIH suggestions<\/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>The FDA and NIH propose\u00a0the\u00a0<a href=\"https:\/\/www.nordicbioscience.com\/why-biomarkers\/fda-biomarker-guidelines-best\/\"><strong>BEST<\/strong><\/a>\u00a0(<strong>B<\/strong>iomarkers,\u00a0<strong>E<\/strong>ndpoint<strong>S<\/strong>, and other\u00a0<strong>T<\/strong>ools) glossary to help interpret the distinctions between the clinical relevance of biomarkers and their different roles in both biomedical research and clinical practice and medical device development.<\/p>\n<p>There are other alternatives to this nomenclature, but adapting a common reference point is critical for a common and consistent understanding. <a href=\"https:\/\/www.nordicbioscience.com\/why-biomarkers\/fda-biomarker-guidelines-best\/\">BEST<\/a> is also extended to biomarker function as it relates to biomarker surrogate endpoints. See the biomarker definitions and terminology below.<\/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\/05\/nordic_bio32566.jpg\" alt=\"\">\n        <\/figure>   \n    <\/div>\n<\/section>\n\n\n<section class=\"accordion-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>\n                    <h2 class=\"mb-4 font-bold xl:mb-8 title text-m-title-lg xl:text-d-title-lg text-navy\">BEST (Biomarkers, EndpointS, and other Tools) glossary<\/h2>\n         \n        <\/div>\n            <ul class=\"accordion\">\n                            <!-- Accordion Item -->\n                <li>\n                    <button data-index=\"1\" \n                            class=\"flex items-center justify-between w-full py-5 font-bold text-m-title-sm xl:text-d-title-sm accordion-button text-navy\">\n                        <span class=\"text-start\">Diagnostic<\/span>\n                        <span id=\"icon-1\" class=\"transition-transform duration-300 text-turquoise\">\n                            <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 16 16\" fill=\"currentColor\" class=\"w-4 h-4 xl:w-6 xl:h-6\">\n                                <path d=\"M8.75 3.75a.75.75 0 0 0-1.5 0v3.5h-3.5a.75.75 0 0 0 0 1.5h3.5v3.5a.75.75 0 0 0 1.5 0v-3.5h3.5a.75.75 0 0 0 0-1.5h-3.5v-3.5Z\" \/>\n                            <\/svg>\n                        <\/span>\n                    <\/button>\n                    <div id=\"content-1\" class=\"overflow-hidden transition-all duration-300 ease-in-out accordion-content max-h-0\">\n                        <div class=\"pb-5 text-sm max-w-[600px] text-blue\">\n                            <div class=\"row row-i-0 row-i-first flex-nowrap\">\n<div class=\"col col-i-1 col-i-last\">\n<div class=\"csv-item d-flex align-items-center\">Detect or confirm presence of the medical condition of interest. Identify individuals with a subtype of the medical condition of interest.<\/div>\n<\/div>\n<\/div>\n                        <\/div>\n                    <\/div>\n                <\/li>\n                            <!-- Accordion Item -->\n                <li>\n                    <button data-index=\"2\" \n                            class=\"flex items-center justify-between w-full py-5 font-bold text-m-title-sm xl:text-d-title-sm accordion-button text-navy\">\n                        <span class=\"text-start\">Monitoring<\/span>\n                        <span id=\"icon-2\" class=\"transition-transform duration-300 text-turquoise\">\n                            <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 16 16\" fill=\"currentColor\" class=\"w-4 h-4 xl:w-6 xl:h-6\">\n                                <path d=\"M8.75 3.75a.75.75 0 0 0-1.5 0v3.5h-3.5a.75.75 0 0 0 0 1.5h3.5v3.5a.75.75 0 0 0 1.5 0v-3.5h3.5a.75.75 0 0 0 0-1.5h-3.5v-3.5Z\" \/>\n                            <\/svg>\n                        <\/span>\n                    <\/button>\n                    <div id=\"content-2\" class=\"overflow-hidden transition-all duration-300 ease-in-out accordion-content max-h-0\">\n                        <div class=\"pb-5 text-sm max-w-[600px] text-blue\">\n                            <div class=\"row row-i-1 flex-nowrap\">\n<div class=\"col col-i-1 col-i-last\">\n<div class=\"csv-item d-flex align-items-center\">Monitoring status of a medical condition by repeated measurements. Assessing possible effect of exposure to a drug or an environmental agent.<\/div>\n<\/div>\n<\/div>\n                        <\/div>\n                    <\/div>\n                <\/li>\n                            <!-- Accordion Item -->\n                <li>\n                    <button data-index=\"3\" \n                            class=\"flex items-center justify-between w-full py-5 font-bold text-m-title-sm xl:text-d-title-sm accordion-button text-navy\">\n                        <span class=\"text-start\">Pharmacodynamic\/response<\/span>\n                        <span id=\"icon-3\" class=\"transition-transform duration-300 text-turquoise\">\n                            <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 16 16\" fill=\"currentColor\" class=\"w-4 h-4 xl:w-6 xl:h-6\">\n                                <path d=\"M8.75 3.75a.75.75 0 0 0-1.5 0v3.5h-3.5a.75.75 0 0 0 0 1.5h3.5v3.5a.75.75 0 0 0 1.5 0v-3.5h3.5a.75.75 0 0 0 0-1.5h-3.5v-3.5Z\" \/>\n                            <\/svg>\n                        <\/span>\n                    <\/button>\n                    <div id=\"content-3\" class=\"overflow-hidden transition-all duration-300 ease-in-out accordion-content max-h-0\">\n                        <div class=\"pb-5 text-sm max-w-[600px] text-blue\">\n                            <div class=\"row row-i-2 flex-nowrap\">\n<div class=\"col col-i-1 col-i-last\">\n<div class=\"csv-item d-flex align-items-center\">Display if a biological response has occurred after exposure to a drug or an environmental agent.<\/div>\n<\/div>\n<\/div>\n                        <\/div>\n                    <\/div>\n                <\/li>\n                            <!-- Accordion Item -->\n                <li>\n                    <button data-index=\"4\" \n                            class=\"flex items-center justify-between w-full py-5 font-bold text-m-title-sm xl:text-d-title-sm accordion-button text-navy\">\n                        <span class=\"text-start\">Prognostic<\/span>\n                        <span id=\"icon-4\" class=\"transition-transform duration-300 text-turquoise\">\n                            <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 16 16\" fill=\"currentColor\" class=\"w-4 h-4 xl:w-6 xl:h-6\">\n                                <path d=\"M8.75 3.75a.75.75 0 0 0-1.5 0v3.5h-3.5a.75.75 0 0 0 0 1.5h3.5v3.5a.75.75 0 0 0 1.5 0v-3.5h3.5a.75.75 0 0 0 0-1.5h-3.5v-3.5Z\" \/>\n                            <\/svg>\n                        <\/span>\n                    <\/button>\n                    <div id=\"content-4\" class=\"overflow-hidden transition-all duration-300 ease-in-out accordion-content max-h-0\">\n                        <div class=\"pb-5 text-sm max-w-[600px] text-blue\">\n                            <div class=\"row row-i-4 flex-nowrap\">\n<div class=\"col col-i-1 col-i-last\">\n<div class=\"csv-item d-flex align-items-center\">Identify probability of a clinical event, disease recurrence or progression in patients with the medical condition of interest.<\/div>\n<\/div>\n<\/div>\n                        <\/div>\n                    <\/div>\n                <\/li>\n                            <!-- Accordion Item -->\n                <li>\n                    <button data-index=\"5\" \n                            class=\"flex items-center justify-between w-full py-5 font-bold text-m-title-sm xl:text-d-title-sm accordion-button text-navy\">\n                        <span class=\"text-start\">Safety<\/span>\n                        <span id=\"icon-5\" class=\"transition-transform duration-300 text-turquoise\">\n                            <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 16 16\" fill=\"currentColor\" class=\"w-4 h-4 xl:w-6 xl:h-6\">\n                                <path d=\"M8.75 3.75a.75.75 0 0 0-1.5 0v3.5h-3.5a.75.75 0 0 0 0 1.5h3.5v3.5a.75.75 0 0 0 1.5 0v-3.5h3.5a.75.75 0 0 0 0-1.5h-3.5v-3.5Z\" \/>\n                            <\/svg>\n                        <\/span>\n                    <\/button>\n                    <div id=\"content-5\" class=\"overflow-hidden transition-all duration-300 ease-in-out accordion-content max-h-0\">\n                        <div class=\"pb-5 text-sm max-w-[600px] text-blue\">\n                            <p>Measure before and\/or after exposure to a drug or environmental agent to assess possible toxicity as an adverse effect.<\/p>\n                        <\/div>\n                    <\/div>\n                <\/li>\n                            <!-- Accordion Item -->\n                <li>\n                    <button data-index=\"6\" \n                            class=\"flex items-center justify-between w-full py-5 font-bold text-m-title-sm xl:text-d-title-sm accordion-button text-navy\">\n                        <span class=\"text-start\">Susceptibility\/Risk<\/span>\n                        <span id=\"icon-6\" class=\"transition-transform duration-300 text-turquoise\">\n                            <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 16 16\" fill=\"currentColor\" class=\"w-4 h-4 xl:w-6 xl:h-6\">\n                                <path d=\"M8.75 3.75a.75.75 0 0 0-1.5 0v3.5h-3.5a.75.75 0 0 0 0 1.5h3.5v3.5a.75.75 0 0 0 1.5 0v-3.5h3.5a.75.75 0 0 0 0-1.5h-3.5v-3.5Z\" \/>\n                            <\/svg>\n                        <\/span>\n                    <\/button>\n                    <div id=\"content-6\" class=\"overflow-hidden transition-all duration-300 ease-in-out accordion-content max-h-0\">\n                        <div class=\"pb-5 text-sm max-w-[600px] text-blue\">\n                            <p>Assessing the potential for developing a medical condition in a subject who does not currently have any symptoms.<\/p>\n                        <\/div>\n                    <\/div>\n                <\/li>\n                    <\/ul>\n    \n    <\/div>\n<\/section>\n\n\n\n<div style=\"height:var(--wp--preset--spacing--50)\" 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