Journal
EXPERT REVIEW OF MOLECULAR DIAGNOSTICS
Volume 15, Issue 2, Pages 211-218Publisher
TAYLOR & FRANCIS AS
DOI: 10.1586/14737159.2015.974561
Keywords
biomarkers; biospecimens; regulatory; reimbursement; standards; systems approaches; validation
Categories
Funding
- Caris Life Sciences
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Making precision (personalized) medicine a routine clinical reality will require a comprehensive inventory of validated biomarkers and molecular diagnostic tests to stratify disease subtypes and improve accuracy in diagnosis and treatment selection. Realization of this promise has been hindered by the poor productivity of biomarker identification and validation. This situation reflects deficiencies that are pervasive across the entire spectrum of biomarker R&D, from discovery to clinical validation and in the failure of regulatory and reimbursement policies to accommodate new classes of biomarkers. The launch of the National Biomarker Development Alliance is the culmination of a 2-year review and consultation process involving diverse stakeholders to advance standards, best practices and guidelines to enhance biomarker discovery and validation by adoption of systems-based approaches and trans-sector collaboration between academia, clinical medicine and relevant private and public sector stakeholders.
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