{"id":6970,"date":"2025-09-13T15:22:25","date_gmt":"2025-09-13T15:22:25","guid":{"rendered":"https:\/\/mdxcro.com\/?post_type=case-studies&#038;p=6970"},"modified":"2026-04-29T07:32:39","modified_gmt":"2026-04-29T07:32:39","slug":"ngs-companion-diagnostic-for-oncology","status":"publish","type":"case-studies","link":"https:\/\/mdxcro.com\/fr\/case-studies\/ngs-companion-diagnostic-for-oncology\/","title":{"rendered":"NGS Companion Diagnostic for Oncology"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Challenge:<\/strong> 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.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Solution:<\/strong> MDx designed a harmonized validation approach that satisfied both regulatory pathways:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Designed analytical and clinical validation studies<\/li>\n\n\n\n<li>Implemented IEC 62304-compliant software validation<\/li>\n\n\n\n<li>Created a unified technical documentation package<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Result:<\/strong> Successful clinical study execution across 9 European centers, with all validation milestones achieved on time and regulatory submissions accepted by both authorities.<\/p>\n","protected":false},"featured_media":6916,"template":"","meta":{"_acf_changed":true},"class_list":["post-6970","case-studies","type-case-studies","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - 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