Technologies that are collectively called omics have made it feasible to measure an enormous number of molecules within a tissue or cell; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Patients look to the scientific community to develop innovative omics-based tests to more reliably detect disease and to predict their likelihood of responding to specific drugs. However, the translation of these new technologies into clinical laboratory tests that can help patients directly has happened more slowly than anticipated.
Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the National Cancer Institute requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. The IOM’s recommendations speak to the many parties responsible for discovery and development of omics-based tests, including investigators, their institutions, sponsors of research, the FDA, and journals. The report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials. The IOM’s recommendations aim to ensure that progress in omics test development is grounded in sound scientific practice and is reproducible, resulting not only in improved health care but also in continued public trust.