{"id":10581,"date":"2025-09-13T15:22:25","date_gmt":"2025-09-13T15:22:25","guid":{"rendered":"https:\/\/mdxcro.com\/case-studies\/ngs-companion-diagnostic-for-oncology\/"},"modified":"2026-03-27T09:03:46","modified_gmt":"2026-03-27T09:03:46","slug":"ngs-companion-diagnostic-for-oncology","status":"publish","type":"case-studies","link":"https:\/\/mdxcro.com\/es\/casos-de-estudio\/ngs-companion-diagnostic-for-oncology\/","title":{"rendered":"Diagn\u00f3stico complementario de NGS para oncolog\u00eda"},"content":{"rendered":"\n<p><strong>Desaf\u00edo:<\/strong> Una empresa de medicina de precisi\u00f3n necesitaba desarrollar y validar un panel de CDx basado en NGS para respaldar la solicitud de terapia dirigida de un socio farmac\u00e9utico bajo los marcos de la FDA y el IVDR.<\/p>\n\n<p><strong>Soluci\u00f3n:<\/strong> MDx dise\u00f1\u00f3 un enfoque de validaci\u00f3n armonizado que satisfizo ambas v\u00edas regulatorias:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Dise\u00f1o de estudios de validaci\u00f3n anal\u00edtica y cl\u00ednica<\/li>\n\n\n\n<li>Implementaci\u00f3n de la validaci\u00f3n de software conforme a la norma IEC 62304<\/li>\n\n\n\n<li>Creaci\u00f3n de un paquete de documentaci\u00f3n t\u00e9cnica unificado<\/li>\n<\/ul>\n\n<p><strong>Resultado:<\/strong> Ejecuci\u00f3n exitosa del estudio cl\u00ednico en 9 centros europeos, con todos los hitos de validaci\u00f3n alcanzados a tiempo y las presentaciones regulatorias aceptadas por ambas autoridades.<\/p>\n","protected":false},"featured_media":6917,"template":"","meta":{"_acf_changed":false},"class_list":["post-10581","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 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Diagn\u00f3stico complementario de NGS para oncolog\u00eda - MDx CRO<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mdxcro.com\/es\/casos-de-estudio\/ngs-companion-diagnostic-for-oncology\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Diagn\u00f3stico complementario de NGS para oncolog\u00eda - MDx CRO\" \/>\n<meta property=\"og:description\" content=\"Desaf\u00edo: Una empresa de medicina de precisi\u00f3n necesitaba desarrollar y validar un panel de CDx basado en NGS para respaldar la solicitud de terapia dirigida de un socio farmac\u00e9utico bajo los marcos de la FDA y el IVDR. Soluci\u00f3n: MDx dise\u00f1\u00f3 un enfoque de validaci\u00f3n armonizado que satisfizo ambas v\u00edas regulatorias: Resultado: Ejecuci\u00f3n exitosa del [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/mdxcro.com\/es\/casos-de-estudio\/ngs-companion-diagnostic-for-oncology\/\" \/>\n<meta property=\"og:site_name\" content=\"MDx CRO\" \/>\n<meta property=\"article:modified_time\" content=\"2026-03-27T09:03:46+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/regulatory-excelence-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"1280\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 minuto\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/casos-de-estudio\\\/ngs-companion-diagnostic-for-oncology\\\/\",\"url\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/casos-de-estudio\\\/ngs-companion-diagnostic-for-oncology\\\/\",\"name\":\"Diagn\u00f3stico complementario de NGS para oncolog\u00eda - 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