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.