{"id":10584,"date":"2025-08-26T10:57:06","date_gmt":"2025-08-26T10:57:06","guid":{"rendered":"https:\/\/mdxcro.com\/case-studies\/precision-medicine-cdx\/"},"modified":"2026-03-27T09:04:19","modified_gmt":"2026-03-27T09:04:19","slug":"precision-medicine-cdx","status":"publish","type":"case-studies","link":"https:\/\/mdxcro.com\/es\/casos-de-estudio\/precision-medicine-cdx\/","title":{"rendered":"Medicina de Precisi\u00f3n\/CDx"},"content":{"rendered":"\n<section id=\"block_de4195694838173cd2a57a69c74ce532\" class=\"text-image text-image--text-only\" style=\"\">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Medicina de Precisi\u00f3n\/CDx<\/h2><div class=\"description wysiwyg\"><p><b>Reto:<\/b><span style=\"font-weight: 400\"> Una empresa biotecnol\u00f3gica estadounidense que desarrolla un CDx basado en NGS necesitaba realizar un estudio de rendimiento bajo el Reglamento IVDR para respaldar tanto el acceso al mercado de la UE como los requisitos de asociaci\u00f3n farmac\u00e9utica.<\/span><\/p>\n<p><b>Soluci\u00f3n:<\/b><span style=\"font-weight: 400\"> MDx dise\u00f1\u00f3 un protocolo conforme al Anexo XIV del Reglamento IVDR con criterios de valoraci\u00f3n terap\u00e9uticos espec\u00edficos, gestion\u00f3 la recogida de muestras en 9 centros oncol\u00f3gicos y coordin\u00f3 con los laboratorios para las pruebas.<\/span><\/p>\n<p><b>Resultado:<\/b><span style=\"font-weight: 400\"> Se complet\u00f3 con \u00e9xito la recogida de muestras para 3 tipos de tumores en 8 meses, con documentaci\u00f3n completa conforme al Reglamento IVDR y paquete de pruebas.<\/span><\/p>\n<\/div><\/div><\/div>                    <\/div>\n    <\/div>\n<\/section>\n","protected":false},"featured_media":6787,"template":"","meta":{"_acf_changed":false},"class_list":["post-10584","case-studies","type-case-studies","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - 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