From genome to bedside: are we lost in translation?

The preceding decade has seen a remarkable technical explosion resulting in an entirely new field designated as "omics". A committee convened by the United States Institute of Medicine (IOM) has defined omics as "characterization of global sets of biological molecules such as DNAs, RNAs, proteins, and metabolites". The IOM report has established a roadmap for translating a newly discovered signature that emerges from an omics-based exploratory study to a true, analytically valid test that has both clinical validity and clinical utility for a specific intended use. This roadmap requires a multi-disciplinary team with expertise in the technical aspects of high-throughput assay development, bioinformatics, clinical test development, and clinical research and statistics. The investigative team should follow one of the pathways laid out by the IOM committee to establish clinical utility of an analytically validated omics-based test, and therefore acceptance by regulatory and guideline bodies: Prospective retrospective studies, or prospective studies in which the omics-based test is the primary objective of the trial itself. Although developed for omics-based tests, these concepts are applicable to any diagnostic test used to direct care of patients with cancer. These pathways are rigorous, and therefore not easily accomplished. However, if we are to apply these tests to direct management of our patients, we must approach the science of biomarker development with the same rigor that is used for therapeutic agent assessment. A "Bad Tumor Marker Is as Bad as a Bad Drug".