Archives: Case studies
Genetic Testing
Challenge: A US laboratory sought to CE mark their NGS clinical exome sequencing panel targeting over 4,000 genes under IVDR.
Solution: MDx developed complete technical documentation for the NGS workflow and bioinformatics pipeline, implemented ISO 13485 QMS, and managed the notified body submission process.
Result: CE mark granted in 16 months, enabling the client to become one of the few laboratories globally to certify such a comprehensive gene panel
Infectious Disease
Challenge: A global manufacturer needed to transition their molecular infectious disease assay from IVDD to IVDR with updated performance claims and expanded intended use.
Solution: MDx implemented a gap assessment, designed a clinical performance strategy compliant with IVDR, and managed sample collection across multiple European countries.
Result: The client achieved IVDR certification with expanded clinical claims, strengthening their market position.
Precision Medicine/CDx
Challenge: A US biotech developing an NGS-based CDx needed to conduct a performance study under IVDR to support both EU market access and pharma partnership requirements.
Solution: MDx designed an IVDR Annex XIV-compliant protocol with therapeutic-specific endpoints, managed sample collection across 9 oncology centers, and coordinated with laboratory sites for testing.
Result: Successfully completed sample collection for 3 tumor types within 8 months, with full IVDR-compliant documentation and evidence package.
Challenge: LDT to IVDR transition + CE mark for an NGS Clinical Exome Sequencing (CES) panel targeting over 4000 genes
Solution: Full technical documentation development for NGS, bioinformatics pipeline, 13485 QMS implementation and notified body submission
Result: CE mark granted in 16 months, enabling the client to become one of the very few laboratories globally to certify such a comprehensive gene panel under IVDR
