Gail Geller, Sc.D., MHS, core faculty of the Johns Hopkins Berman Institute of Bioethics, is a member of the IOM Committee releasing a report Friday, March 23 on the 'path forward' in translating "omics" research into useful clinical tests for detecting disease and recommending drug treatment.
"Omics" is the general term used to describe the fields of study within biology that look at the totality of a complex biological network. So where genetics can focus on individual genes, genomics looks at the complete genetic makeup of an organism.
In the report, Evolution of Translational Omics: Lessons Learned and the Path Forward, Geller and the committee make recommendations to guide the realization of the incredible promise of the human genome sequence breakthrough for treating disease. The IOM committee makes recommendations for better development, evaluation, and translation of omics-based tests while also calling for stronger guidance from the Food and Drug Administration (FDA).
Unlike other research, the huge datasets generated in omics-based research are often not made available for independent review, and the FDA also often declines to review omics-based clinical laboratory tests. The committee calls for both clinical researchers to be more transparent and the FDA to provide clear guidance or regulation that incorporates external review.
Gail Geller: http://www.