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Alliance to Standardize Biomarker Discovery, Validation Process

by | Feb 19, 2015 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Reimbursement-dtet

The success rate in identifying and incorporating clinically meaningful biomarkers into practice is “dismal,” says the newly formed National Biomarker Development Alliance (NBDA). The alliance was announced in January with the goal of establishing an agreed upon comprehensive, evidence-based biomarker development process. These standards are urgently needed, the group says, to identify the high-quality biomarkers required to support personalized medicine. The group, established with assistance from the Research Collaboratory of Arizona State University, will be “disease agnostic” and will focus on developing standards including best practices, guidelines, and standard operating procedures; a national biomarker biorepository; a network to reproduce selected biomarker results; and a common biomarker database. The input of stakeholders nationally representing industry, academia, patient groups, and government is being sought. “Creating the standards and systems for successful biomarker development is complex but achievable through a new generation of networks of stakeholders that integrate knowledge to solve critical problems of this scale,” said Anna Barker, director and co-founder of the NBDA. “The NBDA was developed not just to relegate the flawed and fragmented approaches to biomarker development processes to history but also to serve as a working example of what purposeful convergence of scientific knowledge and multisector collaboration can […]

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