Preparing Your Global CDx Strategy
Clinical & Regulatory Roadmap for Global CDx Programs

Introduction - Why Your Global CDx Strategy Is Critical

Companion diagnostics (CDx) sit at the intersection of diagnostics and therapeutics, requiring synchronized drug-test co-development across multiple regulatory systems. While global regulators share the goal of ensuring patient safety and clinical utility, CDx requirements are not harmonized.

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 Manufacturers must navigate:

• Divergent definitions of companion diagnostics

• Region-specific clinical and analytical evidence thresholds

• Local data expectations and co-review processes

• Limited biomarker-positive populations and assay evolution during development

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Failure to anticipate these challenges early can result in duplicative studies, misaligned submissions, delayed drug launches, or restricted indications.