Given the known disparities in research and development and reimbursement dollars spent on diagnostics compared to therapeutics, the diagnostics industry can feel like an unloved stepchild, compared to the pharmaceutical industry. But what contributes to this undervaluation and how significant it is in the marketplace are the subjects of ongoing expert discussion. Cancer biomarker tests are indeed undervalued, asserts Daniel Hayes, M.D., from the University of Michigan, Ann Arbor, and colleagues in a recent commentary piece published in Science Translational Medicine that critically looks at how to break the vicious cycle of undervaluation that perpetuates future undervaluation. “Unfortunately, stakeholders have not fully recognized the potential value of tumor-biomarker tests; thus, the research, regulatory, clinical-use, and reimbursement standards are not as well defined or as rigorous as those applied to therapeutics,” argues Hayes. “These conditions have generated little enthusiasm (or funding) for development of the high levels of evidence needed to support the clinical utility of tumor-biomarker tests, resulting in a vicious cycle of undervaluation of tumor-biomarker tests in both the professional and patient communities.” The vicious cycle perpetuates itself with too few tumor-biomarker tests establishing clinical utility or guideline recognition, thus leading to a lack of adoption and reimbursement that […]