The past few years have seen a frantic effort in an attempt to discover and validate novel biomarkers for the diagnosis and treatment of diseases such as cancer. Unfortunately, the rate at which biomarkers are being used in actual patient treatment is not increasing accordingly. There are a number of reasons for this discrepancy; one is the failure to recognize and appreciate which validated biomarkers have the greatest chance of being used in a clinical setting. In addition, there is a general lack of understanding within the basic research community of the intricacies involved in the regulatory process required to produce a clinically useful biomarker. Fortunately, a collaboration involving the American Association for Cancer Research, the National Cancer Institute and the US FDA hopes to expedite the process of bringing validated biomarkers to the point where they can have an impact on the diagnosis and treatment of disease.