Abstract
Biomarker profiling is well established as a powerful research tool. These so-called “omics” tests are based on signatures of molecules, such as nucleic acids, proteins, and metabolites. In recent years, the potential utility of such tests in diagnosis and prognosis has attracted much commercial investment. Consequently, the institutions developing these tests are under increasing pressure to deliver them to the clinic. In some cases, this urgency has led to clinical trials of tests that are unfit for purpose, having been generated from error-ridden data. A notable example of this situation occurred at Duke University, where flawed genomic test profiles were used in cancer trials. The recent article by Kaiser (1), summarized below, discusses the failures that led to the controversy at Duke and reviews the lessons learned to help …
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