Policy Issues in the Clinical Development and Use of Predictive Biomarkers for Molecular Targeted Therapies
The policy issues for the development, validation, and clinical implementation of predictive biomarkers for molecularly targeted therapies present a number of challenges. First, there is significant uncertainty in the current regulatory framework for biomarker tests for molecularly targeted therapies. Second, there is concern over the adequacy of the current oversight of laboratories conducting biomarker testing. Third, there is a lack of alignment between the processes for regulatory and reimbursement decisions. All these challenges cause uncertainty and confusion among clinicians, patients, test manufacturers, and payers.
KeywordsPolicy US Food and Drug Administration (FDA) Centers for Medicare and Medicaid Services (CMS) Laboratory-developed procedures (LDPs) Medicare Administrative Contractors (MACs) Companion diagnostics Clinical Laboratory Improvement Amendment (CLIA) of 1988
Contracted private healthcare insurers that process medical claims for Medicare beneficiaries
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