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

Clinical Development Strategy

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Managing Limited Samples, Assay Bridging, and Global Evidence Needs

Clinical development for companion diagnostics must support drug labeling claims, often with small biomarker-positive cohorts and evolving assay platforms.

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Clinical Development Strategic Considerations

• Is the CDx clinical strategy aligned with the therapeutic clinical development plan?

• Are clinical endpoints sufficient to support PMA-level evidence in the US?

• Is there a predefined bridging strategy from trial assay(s) to the commercial
  CDx kit?

• Are multiple assays for the same biomarker being used, and if so, is comparability addressed?

• Has statistical power been assessed, given limited biomarker-positive samples?

• Are clinical studies designed to support multiple regions, not just a single authority?

• Are sample handling, storage, and traceability globally compliant?

• Is the

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Why this matters: Regulators increasingly scrutinize assay comparability and clinical relevance when trial assays differ from marketed CDx kits.​​