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New Biomarker Development Alliance Aims to Address 'Urgent' Need for Standards

NEW YORK (GenomeWeb News) – A non-profit organization called the National Biomarker Development Alliance has launched to develop standards and guidelines for supporting biomarker development and use, the NBDA said today.

The NBDA was created to "address the complex and urgent challenge of creating the standards to support end-to-end evidence-based biomarker development," and will engage partners from industry, academia, government, and patient groups, NBDA said.

The alliance was established and launched today by the Research Collaboratory at Arizona State University

The need, as NBDA sees it, is to "change the current dismal success rate of biomarker discovery, development, and validation." The group noted that only 1.5 protein biomarkers are approved by the US Food and Drug Administration each year and only 100 are used routinely in clinical care. In light of the "tsunami of biomarker discovery," the translation and uptake of these biomarkers is a poor record, the alliance said.

"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," Anna Barker, president and co-founder of the NBDA, said in a statement. Barker is a professor at ASU and formerly was deputy director of the National Cancer Institute.

ASU said the lack of standards for developing biomarkers within the context of an explosion of genomics-based assays and other non-regulated lab-developed tests has stalled advances in the diagnostics industry.

"The undervaluation of biomarkers and reimbursement ambiguities further discourages investments in this field," NBDA said.

The NBDA will create best practices, guidelines, and standard operating procedures that will support new models of biomarker development, and it will make its data, processes, and standards publicly available.

The alliance will also build resources such as a national biomarker repository, a network to reproduce selected biomarker results, and a common biomarker database.

The NBDA has begun to develop standards for four classes of biomarkers, including genomic, proteomic, imaging, and complex biomarkers.

The group also has assembled a database of all guidelines, standard operating procedures, and standards that have been developed to date on the collection, stewardship, and management of biospecimens.

The alliance plans to organize a consensus conference to define standards for the field that can be agreed to by stakeholder groups.

"I know from long experience, that this is not an easy task, but I believe that we already have a great deal of the information needed to get this done and identification of critical knowledge gaps will guide needed research," said ASU Professor Carolyn Compton, who is NBDA's chief medical officer.