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NAS Calls for Single Federal Agency to Oversee 'Unorganized' Biomarker Field

NEW YORK (GenomeWeb News) — Biomarkers may help fight a variety of cancers, but that potential is being undermined by confusing regulations and standards, and “piecemeal and unorganized efforts,” according to a report issued today by the National Academies of Science’s Institute of Medicine.
The Institute proposed a set of suggestions that it said would spur research and development advances in the field, which would include unifying oversight of the field under a single entity.
To realize the potential of biomarkers in cancer medicine, the Institute said, a “single federal agency” is needed that would “coordinate and oversee a more organized approach” to the discovery and development of these markers.
Diagnostic and pharmaceutical companies and federal agencies should partner to “create international research consortia” that would “generate and share data,” the Institute said. It added that these companies would employ resources from different partners that would “benefit the entire field.”
The National Institutes of Health, the National Cancer Institute, and similar agencies should support cell and tissue repositories that could be used to validate new biomarkers, the report advised.
Those who sponsor research should focus on identifying “indicators of cell communication pathways that are involved in many kinds of cancer and other diseases” so the biomarkers would be broadly applicable.
Biomarkers for particular drugs, the Institute said, are “riskier investments” because the drugs could fail.
Underscoring the need for uniform standards is the amount of “false starts” related to biomarker-based breast cancer tests, the Institute said. To remedy that, government agencies and “other stakeholders” should cooperate to offer “guidelines for the development, validation, and use of biomarkers.”

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