Where Are All the New Omics-Based Tests?

“Why?” is the inevitable question. Why have so few biomarkers made it to everyday clinical care? Why, despite billions of dollars worldwide in omics-based research? We have been promised multiple breakthroughs, and numerous biomarker discoveries have been announced, but it is fair to say that, up to this day, clinical medicine has not gone through a radical change, despite all the investment of time, money, and the collaboration of thousands of study participants. Why has this omics-based enterprise resulted in so few clinically useful tests that improve health outcomes or contribute to healthcare efficiency?Sometimes things have gone badly wrong in the process of marker discovery and evaluation, to the extent that the things that went wrong risked undermining the credibility of biomarker research itself. Likely the most famous instance is the Duke University case, in which 3 gene expression–based tests were used in phase II clinical trials. The tests were supposed to be chemosensitivity tests, to guide therapy in patients with breast cancer and lung cancer. It turned out that the tests were based on shaky evidence and poor methods, and that their use in clinical trials could be called premature at best.Outside researchers argued that the omics-based tests did not work and were potentially endangering patient safety by incorrectly directing therapy (1). In 2010, National Cancer Institute (NCI)2 Director Harold Varmus received a letter from >30 scientists, voicing concerns about the tests used in …