FAQ - CDx: Commercialization

Why do CDx products struggle after approval?
Lack of reimbursement planning, unclear value propositions, or restrictive labeling often limit adoption.

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Why must CDx programs consider reimbursement early?

Regulatory approval does not guarantee clinical adoption. Payers often require evidence of clinical utility and cost effectiveness before providing reimbursement. Early consideration of reimbursement strategy helps ensure that clinical studies generate the evidence needed for both regulatory approval and market access.