Evaluating Biomarkers for Guiding Treatment Decisions

The genetic revolution is expected to lead to improved targeting of new and existing forms of treatment. Rather than a one-size-fits-all blockbuster strategy in battling disease with drugs and other interventions, a more precise approach is becoming available, one in which treatment is only offered to those likely to benefit. The identification of those likely to benefit from treatment could be based on one or more biomarkers, but in an era where medical decisions aim to be evidence-based, the use of treatment selection markers should not just be based on hope and optimism, but on solid data from sound research. The performance of the treatment selection marker should be expressed in quantitative terms, similar to the way we express the clinical performance of diagnostic markers, or the performance of prognostic markers.