{"id":11847,"date":"2025-09-13T14:41:42","date_gmt":"2025-09-13T14:41:42","guid":{"rendered":"https:\/\/mdxcro.com\/services\/services-ngs\/"},"modified":"2026-06-24T09:48:47","modified_gmt":"2026-06-24T09:48:47","slug":"services-ngs","status":"publish","type":"service","link":"https:\/\/mdxcro.com\/fr\/services\/services-ngs\/","title":{"rendered":"Services NGS"},"content":{"rendered":"\n<section id=\"block_ec17d48ee8c85238f58ddddf7be80dce\" class=\"hero\">\n    <div class=\"hero--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/precision-medicine.jpg\" fetchpriority=\"high\" class=\"no-lazy\" alt=\"\" \/>\n    <\/div>\n        <div class=\"container\">\n                <div class=\"content\">\n                                    <h1 class=\"title\">Expertise en validation de s\u00e9quen\u00e7age de nouvelle g\u00e9n\u00e9ration et conformit\u00e9 IVDR<\/h1>\n            \n                            <div class=\"description\"><p><span style=\"font-weight: 400;\">De la conception de panels personnalis\u00e9s \u00e0 la validation bioinformatique et \u00e0 la certification IVDR, MDx fournit des solutions NGS de bout en bout, incluant la validation logicielle, l\u2019\u00e9valuation des performances et l\u2019approbation r\u00e9glementaire.<\/span><\/p>\n<\/div>\n            \n                            <div class=\"button-wrapper\">\n                                            <a href=\"https:\/\/mdxcro.com\/fr\/contact\/?utm_content=services_ngs\" class=\"button bouton--par d\u00e9faut\" target=\"_self\">\n                            R\u00e9server une consultation NGS                        <\/a>\n                                            <a href=\"https:\/\/mdxcro.com\/ngs-validation-guideline-for-ivdr-compliance\/\" class=\"button bouton--secondaire\" target=\"_self\">\n                            Consulter notre guide de validation NGS                        <\/a>\n                                    <\/div>\n                            <\/div>\n            <\/div>\n<\/section>\n\n<section id=\"block_f22a74964d8136d942cc02559fad10f0\" class=\"sticky-navbar\" style=\"padding-top: Par d\u00e9faut; padding-bottom: Par d\u00e9faut; margin-top: Par d\u00e9faut; margin-bottom: Par d\u00e9faut; \">\n                <div class=\"container\">\n                <ul class=\"list\">\n                    <li class=\"item\">\n                            <a href=\"#NGS-Solutions\" class=\"link\" target=\"\"> \n                    Solutions NGS \n                <\/a>\n                                <li class=\"item\">\n                            <a href=\"#NGS-Panels-Supported\" class=\"link\" target=\"\"> \n                    Panels NGS pris en charge \n                <\/a>\n                                <li class=\"item\">\n                            <a href=\"#Bioinformatics\" class=\"link\" target=\"\"> \n                    Bioinformatique \n                <\/a>\n                                <li class=\"item\">\n                            <a href=\"#Our-NGS-Process\" class=\"link\" target=\"\"> \n                    Notre processus NGS \n                <\/a>\n                                <li class=\"item\">\n                            <a href=\"#Case-Studies\" class=\"link\" target=\"\"> \n                    \u00c9tudes de Cas \n                <\/a>\n                                <li class=\"item\">\n                            <a href=\"https:\/\/mdxcro.com\/sectors\/laboratories\/\" class=\"link\" target=\"\"> \n                    Services NGS \n                <\/a>\n                            <\/ul>\n                \n    <\/div>\n<\/section>\n\n<section id=\"block_8f04070cce573a30bdfe17759b41c257\" class=\"text-image text-image--wide text-image--video-player\" style=\"\">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Excellence NGS pour un succ\u00e8s r\u00e9glementaire mondial<\/h2><div class=\"description wysiwyg\"><p><span style=\"font-weight: 400\">Les technologies de s\u00e9quen\u00e7age de nouvelle g\u00e9n\u00e9ration n\u00e9cessitent une expertise r\u00e9glementaire sp\u00e9cialis\u00e9e pour naviguer dans le paysage complexe de la validation des performances, de la conformit\u00e9 bioinformatique et des exigences en mati\u00e8re de preuves cliniques. MDx CRO offre un soutien complet pour le   <\/span><a href=\"https:\/\/mdxcro.com\/sectors\/ivd-end-to-end\/\"><span style=\"font-weight: 400\">d\u00e9veloppement d\u2019essais<\/span><\/a><span style=\"font-weight: 400\">, la validation et l\u2019approbation r\u00e9glementaire, vous aidant \u00e0 transformer des technologies g\u00e9nomiques r\u00e9volutionnaires en produits de diagnostic conformes et pr\u00eats pour le march\u00e9.<\/span><\/p>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><div class=\"video-player video-player--youtube\" data-youtube-url=\"https:\/\/www.youtube.com\/embed\/uLKsd0e5Gtk?si=ohiiZQ3qSCIoLgoB\"><div class=\"youtube-container\"><div class=\"youtube-poster\"><img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/What-are-the-main-challenges-with-NGS-based-IVDs.jpg\" alt=\"Innovative MedTech industry expert discussing advancements in medical device development at MDX Accelerating MedTech event.\" \/><button class=\"play-btn youtube-play-btn\"><\/button><\/div><div class=\"youtube-iframe-container\" style=\"display: none\"><!-- Iframe will be created here dynamically --><\/div><\/div><\/div><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_8ec4fb2af89ba88f3e1461aaa736a429\" class=\"text-image text-image--wide text-image--reverse\" style=\"padding-top: var(--wp--preset--spacing--large); padding-bottom: var(--wp--preset--spacing--large); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><div class=\"description wysiwyg\"><p><span style=\"font-weight: 400\">Notre \u00e9quipe de biologistes mol\u00e9culaires, de bioinformaticiens et d\u2019experts r\u00e9glementaires vous guide \u00e0 chaque phase du d\u00e9veloppement de produits NGS, de la conception initiale de l\u2019essai \u00e0 la <\/span><a href=\"https:\/\/mdxcro.com\/services\/ivd-analytical-studies\/\"><span style=\"font-weight: 400\">validation analytique<\/span><\/a><span style=\"font-weight: 400\">, aux <\/span><a href=\"https:\/\/mdxcro.com\/services\/ivd-clinical-studies\/\"><span style=\"font-weight: 400\">\u00e9tudes de performances cliniques<\/span><\/a><span style=\"font-weight: 400\"> et \u00e0 la <\/span><a href=\"https:\/\/mdxcro.com\/services\/regulatory-affairs-technical-documentation\/\"><span style=\"font-weight: 400\">documentation technique<\/span><\/a><span style=\"font-weight: 400\">  pour les soumissions r\u00e9glementaires mondiales. Avec un succ\u00e8s prouv\u00e9 dans la certification de panels complexes sous l\u2019IVDR, y compris le tout premier panel de s\u00e9quen\u00e7age d\u2019exome de plus de 4 000 g\u00e8nes \u00e0 obtenir le marquage CE, MDx est votre partenaire de confiance pour l\u2019excellence r\u00e9glementaire NGS.   <\/span><\/p>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/data-collection.jpg\" alt=\"NGS, qPCR, IHC assay validation for companion diagnostics\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"NGS-Solutions\" class=\"tabs\">\n        <div class=\"container\">\n                    <div class=\"title\">Solutions NGS de bout en bout pour les fabricants d\u2019IVD et les laboratoires cliniques<\/div>\n            <\/div>\n\n    <div class=\"tabs-wrapper\">\n        <!-- Tab Navigation -->\n        <div class=\"tab-navigation\">\n                            <button class=\"tab-button active\" data-tab=\"developpement-et-validation-dessais-ngs\">\n                    D\u00e9veloppement et validation d\u2019essais NGS                <\/button>\n                            <button class=\"tab-button\" data-tab=\"validation-du-pipeline-bioinformatique\">\n                    Validation du pipeline bioinformatique                <\/button>\n                            <button class=\"tab-button\" data-tab=\"etudes-de-performances-cliniques-ngs\">\n                    \u00c9tudes de performances cliniques NGS                <\/button>\n                            <button class=\"tab-button\" data-tab=\"conformite-reglementaire-et-soumissions\">\n                    Conformit\u00e9 r\u00e9glementaire et soumissions                <\/button>\n                    <\/div>\n\n        <!-- Tab Content -->\n        <div class=\"tab-content-wrapper\">\n                            <div class=\"tab-content active\" id=\"developpement-et-validation-dessais-ngs\">\n                    <div class=\"tab-grid\">\n                        <div class=\"tab-left\">\n                            <h3>D\u00e9veloppement et validation d\u2019essais NGS<\/h3>\n                            <div class=\"description wysiwyg\">\n                                <ul>\n<li>Validation des performances analytiques pour les panels cibl\u00e9s et les essais WES\/WGS<\/li>\n<li>V\u00e9rification de la sensibilit\u00e9, de la sp\u00e9cificit\u00e9 et de la pr\u00e9cision<\/li>\n<li>S\u00e9lection du mat\u00e9riel de r\u00e9f\u00e9rence et strat\u00e9gie de validation<\/li>\n<li>Validation du flux de travail pour l\u2019appel et l\u2019interpr\u00e9tation des variants<\/li>\n<li>Performances sur divers types d\u2019\u00e9chantillons et seuils de qualit\u00e9<\/li>\n<li>\u00c9tudes de limite de d\u00e9tection pour les variants \u00e0 faible fr\u00e9quence<\/li>\n<\/ul>\n                            <\/div>\n                        <\/div>\n                        <div class=\"tab-right\">\n                                                            <div class=\"tab-image\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/biomarker-assay-validation.jpg\" alt=\"Innovative medical scientists collaborating in a high-tech laboratory, emphasizing MedTech advancements and healthcare innovation.\" \/>\n                                <\/div>\n                                                    <\/div>\n                    <\/div>\n                    <div class=\"tab-navigation-buttons\">\n                        <button class=\"nav-button prev-button\">Previous<\/button>\n                        <button class=\"nav-button next-button\">\n                            Continue to D\u00e9veloppement et validation d\u2019essais NGS                        <\/button>\n                    <\/div>\n                <\/div>\n                            <div class=\"tab-content\" id=\"validation-du-pipeline-bioinformatique\">\n                    <div class=\"tab-grid\">\n                        <div class=\"tab-left\">\n                            <h3>Validation du pipeline bioinformatique<\/h3>\n                            <div class=\"description wysiwyg\">\n                                <ul>\n<li><a href=\"https:\/\/mdxcro.com\/services\/software-digital-health-ai\/\">Validation logicielle<\/a> align\u00e9e sur les exigences de la norme CEI 62304<\/li>\n<li>Documentation conforme \u00e0 l\u2019IVDR pour les algorithmes bioinformatiques<\/li>\n<li>Contr\u00f4le des versions du pipeline et gestion du changement<\/li>\n<li>V\u00e9rification de l\u2019exactitude et de la reproductibilit\u00e9 de l\u2019appel de variants<\/li>\n<li>Validation de l\u2019alignement, de l\u2019appel de variants et de l\u2019annotation<\/li>\n<li>Tests de cas limites et \u00e9valuation des performances<\/li>\n<li>Classification et documentation des logiciels de dispositifs m\u00e9dicaux<\/li>\n<\/ul>\n                            <\/div>\n                        <\/div>\n                        <div class=\"tab-right\">\n                                                            <div class=\"tab-image\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/regulatory-excelence.jpg\" alt=\"Advanced healthcare professionals discussing innovative MedTech solutions on a tablet in a modern clinical setting.\" \/>\n                                <\/div>\n                                                    <\/div>\n                    <\/div>\n                    <div class=\"tab-navigation-buttons\">\n                        <button class=\"nav-button prev-button\">Previous<\/button>\n                        <button class=\"nav-button next-button\">\n                            Continue to Validation du pipeline bioinformatique                        <\/button>\n                    <\/div>\n                <\/div>\n                            <div class=\"tab-content\" id=\"etudes-de-performances-cliniques-ngs\">\n                    <div class=\"tab-grid\">\n                        <div class=\"tab-left\">\n                            <h3>\u00c9tudes de performances cliniques NGS<\/h3>\n                            <div class=\"description wysiwyg\">\n                                <ul>\n<li>\u00c9valuation des performances cliniques pour les all\u00e9gations diagnostiques<\/li>\n<li>\u00c9tudes de <a href=\"https:\/\/mdxcro.com\/services\/ivd-clinical-studies\/\">validation clinique<\/a> multisites<\/li>\n<li>Collecte d\u2019\u00e9chantillons et gestion des sites d\u2019essais<\/li>\n<li>Conception et ex\u00e9cution d\u2019\u00e9tudes conformes \u00e0 l\u2019ISO 20916<\/li>\n<li>G\u00e9n\u00e9ration de preuves cliniques pour les applications CDx<\/li>\n<li>\u00c9tudes de stratification des patients pour les applications en oncologie<\/li>\n<li>Reproductibilit\u00e9 entre les sites de laboratoire et les op\u00e9rateurs<\/li>\n<\/ul>\n                            <\/div>\n                        <\/div>\n                        <div class=\"tab-right\">\n                                                            <div class=\"tab-image\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/Untitled-61.jpg\" alt=\"Microscope research in a advanced medical technology lab, focusing on innovative healthcare solutions and MedTech development.\" \/>\n                                <\/div>\n                                                    <\/div>\n                    <\/div>\n                    <div class=\"tab-navigation-buttons\">\n                        <button class=\"nav-button prev-button\">Previous<\/button>\n                        <button class=\"nav-button next-button\">\n                            Continue to \u00c9tudes de performances cliniques NGS                        <\/button>\n                    <\/div>\n                <\/div>\n                            <div class=\"tab-content\" id=\"conformite-reglementaire-et-soumissions\">\n                    <div class=\"tab-grid\">\n                        <div class=\"tab-left\">\n                            <h3>Conformit\u00e9 r\u00e9glementaire et soumissions<\/h3>\n                            <div class=\"description wysiwyg\">\n                                <ul>\n<li>Documentation technique IVDR pour les essais et flux de travail NGS<\/li>\n<li><a href=\"https:\/\/mdxcro.com\/services\/scientific-validity-reports\/\">Rapports de validit\u00e9 scientifique<\/a> pour les biomarqueurs g\u00e9n\u00e9tiques<\/li>\n<li>Plans et rapports d\u2019\u00e9valuation des performances<\/li>\n<li>Gestion des risques pour les d\u00e9fis sp\u00e9cifiques au NGS<\/li>\n<li>Strat\u00e9gie de soumission et soutien aupr\u00e8s de l\u2019organisme notifi\u00e9<\/li>\n<li>Soumissions \u00e0 la FDA pour les tests et plateformes bas\u00e9s sur le NGS<\/li>\n<li>Consultation de l\u2019EMA pour les <a href=\"https:\/\/mdxcro.com\/services\/precision-medicine-companion-diagnostics\/\">diagnostics compagnons<\/a><\/li>\n<\/ul>\n                            <\/div>\n                        <\/div>\n                        <div class=\"tab-right\">\n                                                            <div class=\"tab-image\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/Untitled-84.jpg\" alt=\"Conformit\u00e9 r\u00e9glementaire et soumissions\" \/>\n                                <\/div>\n                                                    <\/div>\n                    <\/div>\n                    <div class=\"tab-navigation-buttons\">\n                        <button class=\"nav-button prev-button\">Previous<\/button>\n                        <button class=\"nav-button next-button\">\n                            Continue to Conformit\u00e9 r\u00e9glementaire et soumissions                        <\/button>\n                    <\/div>\n                <\/div>\n                    <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"NGS-Panels-Supported\" class=\"flip-cards flip-cards--three-columns flip-cards--card-size-small \" style=\"padding-bottom: var(--wp--preset--spacing--regular); \">\n            <div class=\"container\">\n        <div class=\"content\">\n            \n                            <h2 class=\"title\">Types de panels NGS que nous prenons en charge<\/h2>\n            \n            \n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <div class=\"card card--background-white\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Panels cibl\u00e9s<\/div>\n                        <div class=\"back\"><ul>\n<li>Panels de points chauds (hotspots) du cancer<\/li>\n<li>Panels de maladies h\u00e9r\u00e9ditaires<\/li>\n<li>Pharmacog\u00e9nomique<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">S\u00e9quen\u00e7age de l\u2019exome<\/div>\n                        <div class=\"back\"><ul>\n<li>Exome complet<\/li>\n<li>Exome clinique<\/li>\n<li>Exomes focalis\u00e9s<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Transcriptomique<\/div>\n                        <div class=\"back\"><ul>\n<li>RNA-seq<\/li>\n<li>Panels d\u2019expression g\u00e9nique<\/li>\n<li>D\u00e9tection de fusions<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Diagnostics compagnons<\/div>\n                        <div class=\"back\"><p>Profilage des mutations tumorales, \u00e9valuation du HRD, s\u00e9lection de th\u00e9rapies<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Biopsie liquide<\/div>\n                        <div class=\"back\"><ul>\n<li>Analyse de l\u2019ADNct<\/li>\n<li>Maladie r\u00e9siduelle minimale (MRD)<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">M\u00e9tag\u00e9nomique<\/div>\n                        <div class=\"back\"><ul>\n<li>Identification microbienne<\/li>\n<li>D\u00e9tection de l\u2019AMR<\/li>\n<li>Panels de pathog\u00e8nes<\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                            <\/div>\n        \n            <\/div>\n<\/section>\n<section id=\"Bioinformatics\" class=\"flip-cards flip-cards--three-columns \" style=\"\">\n            <div class=\"container\">\n        <div class=\"content\">\n            \n                            <h2 class=\"title\">Validation de logiciels bioinformatiques<\/h2>\n            \n                            <div class=\"teaser wysiwyg\"><p><span style=\"font-weight: 400;\">L\u2019\u00e9quipe sp\u00e9cialis\u00e9e en validation logicielle de MDx comble le foss\u00e9 entre l\u2019innovation bioinformatique et la conformit\u00e9 r\u00e9glementaire, garantissant que vos pipelines d\u2019analyse de donn\u00e9es NGS r\u00e9pondent \u00e0 toutes les exigences applicables :<\/span><\/p>\n<\/div>\n            \n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Cycle de vie du d\u00e9veloppement logiciel (SDLC)<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Processus de d\u00e9veloppement et cybers\u00e9curit\u00e9 conformes \u00e0 la norme CEI 62304<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Sp\u00e9cification des exigences logicielles pour les outils bioinformatiques<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Documentation de conception et validation de l\u2019architecture<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Gestion des risques selon l\u2019ISO 14971 pour les composants logiciels<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Contr\u00f4le des versions et gestion de la configuration<\/span><\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Validation d\u2019algorithmes<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">\u00c9valuation des performances des algorithmes d\u2019appel de variants<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Validation statistique des m\u00e9thodes de classification<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Tests et analyse comparative des ensembles de donn\u00e9es de r\u00e9f\u00e9rence<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Tests de cas limites pour les r\u00e9gions g\u00e9nomiques complexes<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Validation des strat\u00e9gies de filtrage et des mesures de qualit\u00e9<\/span><\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-black\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Tests d\u2019int\u00e9gration<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Validation du pipeline de bout en bout<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Int\u00e9gration avec le LIMS et les syst\u00e8mes de reporting<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">V\u00e9rification de l\u2019int\u00e9grit\u00e9 des donn\u00e9es tout au long du flux de travail<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Qualification des performances en conditions r\u00e9elles<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Validation de l\u2019interface utilisateur et des sorties<\/span><\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                            <\/div>\n        \n            <\/div>\n<\/section><section class=\"table\"><div class=\"container\"><div class=\"headline\">Pourquoi choisir MDx pour la conformit\u00e9 r\u00e9glementaire NGS ? Notre expertise diff\u00e9renci\u00e9e, nos services r\u00e9glementaires NGS<\/div><div class=\"table-wrapper\"><div class=\"feature-column-wrapper\"><table class=\"feature-table\"><thead><tr><th class=\"feature-column\">Capacit\u00e9<\/th><\/tr><\/thead><tbody><tr><td class=\"feature-cell\"><strong>Exp\u00e9rience IVDR sp\u00e9cifique au NGS<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Validation de logiciels bioinformatiques<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Conception d\u2019\u00e9tudes cliniques NGS<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Exp\u00e9rience des panels de grande taille<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Diagnostic compagnon NGS<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Validit\u00e9 scientifique NGS<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Soumissions NGS mondiales<\/strong><\/td><\/tr><\/tbody><\/table><\/div><div class=\"scrollable-columns-wrapper\"><table class=\"comparison-table\"><thead><tr><th class=\"column highlight\">MDx CRO<\/th><th class=\"column\">Consultants types<\/th><\/tr><\/thead><tbody><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Premier panel de plus de 4 000 g\u00e8nes certifi\u00e9 mondialement<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Exp\u00e9rience IVDR NGS limit\u00e9e<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">M\u00e9thodologie align\u00e9e sur la norme CEI 62304<\/td><td class=\"cell\"><img decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Expertise logicielle souvent manquante<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">ISO 20916 + protocoles sp\u00e9cifiques au NGS<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Approches g\u00e9n\u00e9riques<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">WES, panels complets sur le cancer<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Principalement des panels de petite taille<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">D\u00e9veloppement de CDx de bout en bout<\/td><td class=\"cell\"><img decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Int\u00e9gration pharmaceutique limit\u00e9e<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Documentation compl\u00e8te sur les biomarqueurs<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Collecte de preuves limit\u00e9e<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Strat\u00e9gie r\u00e9glementaire UE, \u00c9tats-Unis, Royaume-Uni<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Focus r\u00e9gional uniquement<\/td><\/tr><\/tbody><\/table><\/div><\/div><\/div><\/section>\n<section class=\"key-stats\"  style=\"\">\n    <div class=\"container\">\n          <div class=\"headline\">Indicateurs de succ\u00e8s<\/div>\n    \n    <div class=\"main-wrapper\">\n              <div class=\"box-grid\">\n                                    <div class=\"box\">\n                                  <div class=\"value\">Tout premier<\/div>\n                                                  <div class=\"legend\">panel NGS de plus de 4 000 g\u00e8nes \u00e0 obtenir le marquage CE sous l\u2019IVDR<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">10+<\/div>\n                                                  <div class=\"legend\">essais NGS valid\u00e9s avec succ\u00e8s et soumis sous l\u2019IVDR<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">100%<\/div>\n                                                  <div class=\"legend\">taux de r\u00e9ussite dans les soumissions de documentation technique NGS<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">40%<\/div>\n                                                  <div class=\"legend\">mise sur le march\u00e9 plus rapide par rapport aux soumissions internes<\/div>\n                              <\/div>\n                              <\/div>\n      \n          <\/div>\n\n    <div class=\"data\">\n      \n          <\/div>\n  <\/div>\n<\/section>\n\n<section id=\"Our-NGS-Process\" class=\"flip-cards flip-cards--three-columns \" style=\"\">\n            <div class=\"container\">\n        <div class=\"content\">\n            \n                            <h2 class=\"title\">Notre processus de validation NGS<\/h2>\n            \n            \n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <div class=\"card card--background-white card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">1.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">\u00c9valuation et strat\u00e9gie<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Examen de la technologie et de l\u2019essai NGS<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">D\u00e9termination de la voie r\u00e9glementaire<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Analyse des \u00e9carts par rapport aux exigences<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Planification de la validation et allocation des ressources<\/span><\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">2.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Validation analytique<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">D\u00e9veloppement de protocoles<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">S\u00e9lection d\u2019\u00e9chantillons de r\u00e9f\u00e9rence<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Tests de sensibilit\u00e9, de sp\u00e9cificit\u00e9 et de pr\u00e9cision<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">V\u00e9rification du pipeline bioinformatique<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Analyse des donn\u00e9es et \u00e9valuation des performances<\/span><\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">3.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Validation clinique<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Conception de l\u2019\u00e9tude de performances cliniques<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">S\u00e9lection et qualification des sites<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Collecte et traitement des \u00e9chantillons<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">V\u00e9rification des donn\u00e9es et contr\u00f4le qualit\u00e9<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Analyse statistique et soutien aux all\u00e9gations<\/span><\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">4.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Documentation r\u00e9glementaire<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Compilation du dossier technique<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Documentation logicielle selon la norme CEI 62304<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Rapports d\u2019\u00e9valuation des performances<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">\u00c9valuation de la validit\u00e9 scientifique<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Documentation sur la gestion des risques<\/span><\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">5.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Soumission et soutien<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Gestion de la soumission \u00e0 l\u2019organisme notifi\u00e9<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">R\u00e9ponses aux demandes d\u2019informations compl\u00e9mentaires<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Planification de la surveillance apr\u00e8s commercialisation<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Conception et mise en \u0153uvre de l\u2019\u00e9tude PMPF<\/span><\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--has-bg-image card--image-only\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/logo-card-rectangle-blue.png&#039;);\"                         >\n                        \n                                                                            \n                        <div class=\"front\"><\/div>\n                        <div class=\"back\"><\/div>\n                    <\/div>\n                            <\/div>\n        \n            <\/div>\n<\/section>\n<section id=\"Case-Studies\" class=\"case-study-details\" style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/testimonials-bg.jpg&#039;);\">\n    \n    \n    <div class=\"container\">\n                    <div class=\"headline\">\u00c9tudes de Cas<\/div>\n        \n                    <div class=\"slider\">\n                                    <div class=\"slider-item\" data-button-url=\"https:\/\/mdxcro.com\/fr\/case-studies\/class-c-ngs-exome-sequencing-panel\/\">\n                                                <div class=\"subtitle\">Class C NGS Exome Sequencing Panel<\/div>\n                                            <div class=\"list\">\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/challenge.svg\" alt=\"Challenge\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Challenge <\/span>\n                                        <p><span style=\"font-weight: 400;\">A genomics laboratory sought to CE mark their NGS exome sequencing panel targeting over 4,000 genes under IVDR-an unprecedented scale for IVDR certification.<\/span><\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/solution.svg\" alt=\"Solution\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Solution <\/span>\n                                        <p><span style=\"font-weight: 400;\">MDx implemented a comprehensive regulatory strategy including:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Complete technical documentation for the NGS workflow<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Validation of the bioinformatics pipeline as a medical device<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Implementation of ISO 13485 QMS tailored to NGS operations<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Expert management of the Notified Body submission process<\/span><\/li>\n<\/ul>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/result.svg\" alt=\"Result\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Result <\/span>\n                                        <p><span style=\"font-weight: 400;\">CE mark granted in just 16 months, enabling the client to become one of the first laboratories globally to certify such a comprehensive gene panel under IVDR.<\/span><\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                <\/div>\n                    <\/div>\n                                    <div class=\"slider-item\" data-button-url=\"https:\/\/mdxcro.com\/fr\/case-studies\/ngs-companion-diagnostic-for-oncology\/\">\n                                                <div class=\"subtitle\">NGS Companion Diagnostic for Oncology<\/div>\n                                            <div class=\"list\">\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/challenge.svg\" alt=\"Challenge\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Challenge <\/span>\n                                        <p><span style=\"font-weight: 400;\">A precision medicine company needed to develop and validate an NGS-based CDx panel to support a pharmaceutical partner&rsquo;s targeted therapy application under both FDA and IVDR frameworks.<\/span><\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/solution.svg\" alt=\"Solution\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Solution <\/span>\n                                        <p><span style=\"font-weight: 400;\">MDx designed a harmonized validation approach that satisfied both regulatory pathways:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Designed analytical and clinical validation studies<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Implemented IEC 62304-compliant software validation<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Created a unified technical documentation package<\/span><\/li>\n<\/ul>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/result.svg\" alt=\"Result\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Result <\/span>\n                                        <p><span style=\"font-weight: 400;\">Successful clinical study execution across 9 European centers, with all validation milestones achieved on time and regulatory submissions accepted by both authorities.<\/span><\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                <\/div>\n                    <\/div>\n                            <\/div>\n        \n        <div class=\"footer\">\n            <div class=\"slider-dots\"><\/div>\n            <div class=\"button-wrapper\">\n                <a href=\"\/resources\/?category=case-studies\" class=\"button button--tertiary\">View Case Studies<\/a>\n            <\/div>\n        <\/div>\n    <\/div>\n<\/section>\n<section id=\"block_5bcd7f39eee87bf79ae3efc176282cc3\" class=\"faqs\" style=\"padding-top: Par d\u00e9faut; padding-bottom: Par d\u00e9faut; margin-top: Par d\u00e9faut; margin-bottom: Par d\u00e9faut; \">\n    <div class=\"container\">\n    <div class=\"content\">\n      <div class=\"column\">\n                  <h2 class=\"headline\">Questions fr\u00e9quemment pos\u00e9es<\/h2>\n                          <a class=\"button button--default\" href=\"https:\/\/mdxcro.com\/fr\/contact\/?utm_content=ngs_service\" target=\"\">\n            Posez-nous une question          <\/a>\n              <\/div>\n      <div class=\"column\">\n                  <ul class=\"faq-list\">\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Comment l\u2019IVDR classifie-t-il les tests bas\u00e9s sur le NGS ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">La plupart des tests de diagnostic bas\u00e9s sur le NGS entrent dans la classe C de l\u2019IVDR en raison de leur finalit\u00e9 (fournissant souvent des informations sur les risques individuels \u00e9lev\u00e9s) ou dans la classe D s\u2019ils sont utilis\u00e9s pour des maladies infectieuses pr\u00e9sentant un risque \u00e9lev\u00e9 pour la sant\u00e9 publique. La classification d\u00e9pend des all\u00e9gations sp\u00e9cifiques, de l\u2019utilisation pr\u00e9vue et du profil de risque de votre test. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Quels sont les principaux d\u00e9fis de la validation des pipelines bioinformatiques NGS ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Les principaux d\u00e9fis consistent \u00e0 d\u00e9montrer des performances constantes sur divers \u00e9chantillons, \u00e0 valider l\u2019exactitude de l\u2019appel de variants, \u00e0 \u00e9tablir un contr\u00f4le des versions, \u00e0 documenter les sp\u00e9cifications des algorithmes selon la norme CEI 62304 et \u00e0 prouver la validit\u00e9 clinique des variants d\u00e9tect\u00e9s. Notre approche rel\u00e8ve chaque d\u00e9fi avec des protocoles sp\u00e9cialis\u00e9s et des mod\u00e8les de documentation.  En savoir plus sur la <a href=\"https:\/\/mdxcro.com\/samd-compliance-guide-mdr-ai-act\/\">validation bioinformatique NGS.<\/a><\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Comment les laboratoires peuvent-ils passer des LDT aux essais NGS conformes \u00e0 l\u2019IVDR ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">La transition n\u00e9cessite la mise en \u0153uvre d\u2019un SMQ conforme \u00e0 la norme 13485, le d\u00e9veloppement d\u2019une documentation technique compl\u00e8te, la validation des composants de laboratoire humide et bioinformatiques, la g\u00e9n\u00e9ration de preuves cliniques et la pr\u00e9paration \u00e0 l\u2019\u00e9valuation par l\u2019organisme notifi\u00e9. MDx propose un programme de transition structur\u00e9 sp\u00e9cifiquement pour les laboratoires effectuant ce changement. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Quelle exp\u00e9rience MDx poss\u00e8de-t-il en mati\u00e8re de diagnostics compagnons NGS ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Nous avons soutenu plusieurs programmes de CDx NGS impliquant une consultation de l\u2019EMA, des \u00e9tudes cliniques align\u00e9es sur le secteur pharmaceutique et des soumissions simultan\u00e9es \u00e0 la FDA et sous l\u2019IVDR. Notre expertise couvre les strat\u00e9gies CDx bas\u00e9es sur l\u2019IHC et le NGS avec des indications s\u2019\u00e9tendant \u00e0 l\u2019oncologie, aux maladies rares et \u00e0 l\u2019immunologie. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Comment validez-vous les performances cliniques d\u2019un test NGS ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Nous concevons des \u00e9tudes de performances cliniques conformes \u00e0 l\u2019ISO 20916 qui d\u00e9montrent la capacit\u00e9 de l\u2019essai \u00e0 identifier correctement l\u2019\u00e9tat clinique ou le statut g\u00e9n\u00e9tique, ou les donn\u00e9es sont recueillies par l\u2019exp\u00e9rience publi\u00e9e dans les tests de diagnostic de routine. Cela implique une conception d\u2019\u00e9tude minutieuse, une comparaison avec une m\u00e9thode de r\u00e9f\u00e9rence, la s\u00e9lection des sites, des protocoles de traitement des \u00e9chantillons et des plans d\u2019analyse statistique adapt\u00e9s \u00e0 la technologie NGS et aux all\u00e9gations sp\u00e9cifiques. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">MDx peut-il soutenir \u00e0 la fois le d\u00e9veloppement de kits commerciaux et les tests NGS d\u00e9velopp\u00e9s en laboratoire ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Oui. Nous soutenons \u00e0 la fois les fabricants de kits IVD commerciaux et les laboratoires qui font \u00e9voluer leurs essais NGS d\u00e9velopp\u00e9s en interne pour se conformer \u00e0 l\u2019IVDR. Notre approche est adapt\u00e9e \u00e0 chaque sc\u00e9nario, r\u00e9pondant aux exigences r\u00e9glementaires et techniques sp\u00e9cifiques de votre mod\u00e8le d\u2019affaires.   En savoir plus sur nos <a href=\"https:\/\/mdxcro.com\/ivdr-for-ngs-assays-challenges-and-solutions\/\">services de validation NGS et de conformit\u00e9 IVDR.<\/a><\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                      <\/ul>\n              <\/div>\n    <\/div>\n  <\/div>\n<\/section>\n\n  <script type=\"application\/ld+json\">\n    {\"@context\":\"https:\/\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Comment l\u2019IVDR classifie-t-il les tests bas\u00e9s sur le NGS ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"La plupart des tests de diagnostic bas\u00e9s sur le NGS entrent dans la classe C de l\u2019IVDR en raison de leur finalit\u00e9 (fournissant souvent des informations sur les risques individuels \u00e9lev\u00e9s) ou dans la classe D s\u2019ils sont utilis\u00e9s pour des maladies infectieuses pr\u00e9sentant un risque \u00e9lev\u00e9 pour la sant\u00e9 publique. 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En savoir plus sur la validation bioinformatique NGS.\"}},{\"@type\":\"Question\",\"name\":\"Comment les laboratoires peuvent-ils passer des LDT aux essais NGS conformes \u00e0 l\u2019IVDR ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"La transition n\u00e9cessite la mise en \u0153uvre d\u2019un SMQ conforme \u00e0 la norme 13485, le d\u00e9veloppement d\u2019une documentation technique compl\u00e8te, la validation des composants de laboratoire humide et bioinformatiques, la g\u00e9n\u00e9ration de preuves cliniques et la pr\u00e9paration \u00e0 l\u2019\u00e9valuation par l\u2019organisme notifi\u00e9. MDx propose un programme de transition structur\u00e9 sp\u00e9cifiquement pour les laboratoires effectuant ce changement.\"}},{\"@type\":\"Question\",\"name\":\"Quelle exp\u00e9rience MDx poss\u00e8de-t-il en mati\u00e8re de diagnostics compagnons NGS ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Nous avons soutenu plusieurs programmes de CDx NGS impliquant une consultation de l\u2019EMA, des \u00e9tudes cliniques align\u00e9es sur le secteur pharmaceutique et des soumissions simultan\u00e9es \u00e0 la FDA et sous l\u2019IVDR. Notre expertise couvre les strat\u00e9gies CDx bas\u00e9es sur l\u2019IHC et le NGS avec des indications s\u2019\u00e9tendant \u00e0 l\u2019oncologie, aux maladies rares et \u00e0 l\u2019immunologie.\"}},{\"@type\":\"Question\",\"name\":\"Comment validez-vous les performances cliniques d\u2019un test NGS ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Nous concevons des \u00e9tudes de performances cliniques conformes \u00e0 l\u2019ISO 20916 qui d\u00e9montrent la capacit\u00e9 de l\u2019essai \u00e0 identifier correctement l\u2019\u00e9tat clinique ou le statut g\u00e9n\u00e9tique, ou les donn\u00e9es sont recueillies par l\u2019exp\u00e9rience publi\u00e9e dans les tests de diagnostic de routine. Cela implique une conception d\u2019\u00e9tude minutieuse, une comparaison avec une m\u00e9thode de r\u00e9f\u00e9rence, la s\u00e9lection des sites, des protocoles de traitement des \u00e9chantillons et des plans d\u2019analyse statistique adapt\u00e9s \u00e0 la technologie NGS et aux all\u00e9gations sp\u00e9cifiques.\"}},{\"@type\":\"Question\",\"name\":\"MDx peut-il soutenir \u00e0 la fois le d\u00e9veloppement de kits commerciaux et les tests NGS d\u00e9velopp\u00e9s en laboratoire ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Oui. Nous soutenons \u00e0 la fois les fabricants de kits IVD commerciaux et les laboratoires qui font \u00e9voluer leurs essais NGS d\u00e9velopp\u00e9s en interne pour se conformer \u00e0 l\u2019IVDR. Notre approche est adapt\u00e9e \u00e0 chaque sc\u00e9nario, r\u00e9pondant aux exigences r\u00e9glementaires et techniques sp\u00e9cifiques de votre mod\u00e8le d\u2019affaires.   En savoir plus sur nos services de validation NGS et de conformit\u00e9 IVDR.\"}}]}  <\/script>\n\n<section id=\"block_a8d36e3404010fdb4085d35e7e974e9a\" class=\"testimonials\" style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/quality-hero.jpg&#039;);\">\n        <div class=\"testimonials--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/quality-hero.jpg\" alt=\"\" \/>\n    <\/div>\n    <div class=\"container\">\n                    <div class=\"headline\">T\u00e9moignages clients<\/div>\n        \n                    <div class=\"slider\">\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00ab\u00a0MDx&rsquo;s expertise in NGS validation and bioinformatics compliance was instrumental in our IVDR certification. Their team&rsquo;s deep understanding of both the technical aspects of sequencing and the regulatory requirements helped us navigate a complex submission with confidence.\u00a0\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                Head of Regulatory Affairs                                                                 <br>\n                                US Genomics Laboratory                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00ab\u00a0When faced with validating our comprehensive tumor profiling panel, MDx provided the expertise we couldn&rsquo;t find elsewhere. Their understanding of both NGS technology and IVDR requirements saved us months of work and ensured our successful approval.\u00a0\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                Chief Scientific Officer                                                                 <br>\n                                Precision Oncology Company                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00ab\u00a0MDx documented our NGS pipeline end-to-end\u2014from wet lab through variant calling and reporting\u2014and built a validation package we could defend. Their focus on reproducibility, software lifecycle controls, and traceability satisfied the Notified Body.\u00a0\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                Laboratory Director                                                                <br>\n                                Pan-European Genomics Center                                        \n                            <\/p>\n                                            <\/div>\n                            <\/div>\n        \n        <div class=\"footer\">\n            <div class=\"slider-dots\"><\/div>\n            <div class=\"button-wrapper\">\n                            <\/div>\n        <\/div>\n    <\/div>\n<\/section>\n\n\n<section id=\"block_bd7db65eb8d6764477e4568d2302508f\" class=\"call-to-action\" style=\"padding-top: Par d\u00e9faut; padding-bottom: Par d\u00e9faut; margin-top: Par d\u00e9faut; margin-bottom: Par d\u00e9faut; \">\n        <div class=\"call-to-action--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/mdx-cta-bg.png\" alt=\"\" \/>\n    <\/div>\n    <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"content\">\n                                    <h2 class=\"title\">Acc\u00e9l\u00e9rez votre succ\u00e8s r\u00e9glementaire NGS<\/h2>\n                \n                                    <div class=\"description wysiwyg\">\n                        <p><span style=\"font-weight: 400;\">Que vous d\u00e9veloppiez un panel cibl\u00e9, un test d\u2019exome complet ou un diagnostic compagnon bas\u00e9 sur le NGS, MDx apporte l\u2019expertise sp\u00e9cialis\u00e9e dont vous avez besoin pour valider, documenter et certifier votre technologie pour les march\u00e9s mondiaux.<\/span><\/p>\n<p><b>Du s\u00e9quen\u00e7age \u00e0 la certification. Nous tenons nos promesses. <\/b><\/p>\n                    <\/div>\n                            <\/div>\n\n                            <div class=\"button-wrapper\">\n                                                                        <a href=\"https:\/\/mdxcro.com\/fr\/contact\/?utm_content=ngs_service\" class=\"button button--secondary\" target=\"\">\n                                R\u00e9server une consultation de strat\u00e9gie NGS                            <\/a>\n                                                            <\/div>\n                    <\/div>\n    <\/div>\n<\/section>\n\n<script type=\"application\/ld+json\">{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@type\": \"Service\",\n  \"serviceType\": \"Next-Generation Sequencing (NGS) Regulatory Services\",\n  \"provider\": {\n    \"@type\": \"Organization\",\n    \"name\": \"MDx CRO\",\n    \"url\": \"https:\/\/www.mdxcro.com\",\n    \"logo\": \"https:\/\/www.mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX.svg\"\n  },\n  \"areaServed\": [\n    {\n      \"@type\": \"Place\",\n      \"name\": \"European Union\"\n    },\n    {\n      \"@type\": \"Place\", \n      \"name\": \"United States\"\n    },\n    {\n      \"@type\": \"Place\",\n      \"name\": \"Asia\"\n    }\n  ],\n  \"description\": \"Specialized NGS regulatory consulting for IVDR compliance, including bioinformatics validation, analytical performance studies, and clinical evidence generation for next-generation sequencing diagnostics.\",\n  \"hasOfferCatalog\": {\n    \"@type\": \"OfferCatalog\",\n    \"name\": \"NGS Services\",\n    \"itemListElement\": [\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"NGS Bioinformatics Validation\"\n        }\n      },\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"NGS Analytical Performance Studies\"\n        }\n      },\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"NGS Clinical Evidence Package\"\n        }\n      },\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"IVDR Compliance for NGS Panels\"\n        }\n      }\n    ]\n  }\n}\n<\/script>\n","protected":false},"featured_media":0,"parent":0,"menu_order":0,"template":"","meta":{"_acf_changed":false},"class_list":["post-11847","service","type-service","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Validation d\u2019essais NGS et conformit\u00e9 du pipeline bioinformatique | Experts IVDR<\/title>\n<meta name=\"description\" content=\"Validation de panels NGS dirig\u00e9e par des experts, conformit\u00e9 bioinformatique et approbation r\u00e9glementaire sous l\u2019IVDR. 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