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

Discovery & Feasibility Strategy

​

Addressing Global Co-Development Complexity Early

Early feasibility decisions determine whether a CDx program can realistically support parallel or near-parallel global drug approvals.

​

Discovery & Feasibility Strategic Considerations

• Is the biomarker biologically and clinically justified for the intended therapeutic indication?

• Is the intended CDx role clearly defined (companion vs complementary vs stratification)?

• Has the drug-diagnostic co-development model been formally agreed (single sponsor vs partnered)?

• Are differences in CDx definitions across major regional regulatory bodies like the FDA, IVDR, NMPA, and PMDA understood?

• Has feasibility been assessed for rare or heterogeneous biomarker-positive populations?

• Is there a strategy for managing assay evolution from clinical trial assay to commercial kit?

• Are early regulatory interactions planned to confirm CDx classification and evidence expectations?​

​

Why this matters: Many CDx programs fail in achieving a global strategy because feasibility was assessed only for one region or with limited sample types, without accounting for global evidence divergence.

​