The Burrill Report | Biodesix

Some of the fastest evolving tools for evaluating the molecular and genetic underpinnings of disease are proving difficult to wield. Despite their great potential, it has been difficult to translate data generated through genomics, proteomics, and metabolomics into actual improvements in patient care.  In hopes of speeding that progress, The Institute of Medicine in March outlined best practices for developing and assessing molecular diagnostic and genetic tests—collectively called “omics-based tests”—in a comprehensive landmark report. Its report, “Evolution of Translational Omics: Lessons Learned and the Path Forward,” offers researchers, funders, the FDA, and medical journal editors a rigorous framework for avoiding the mistakes and embarrassments that have marred the field in the past. By identifying best practices for the development, evaluation, and translation of omics-based tests, the institute says it hopes to strengthen steps taken to ensure that such tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials. (Comments and input from Jeffrey Bojar, Biodesix’ Vice President of Legal and Regulatory Affairs). Read more at the Burrill Report.