Any novel risk factor must meet a number of criteria before achieving clinical utility. These include consistency of prospective data, strength and magnitude of association, and the independence of that association in epidemiologic studies. Further, there must be a standardized measure with low variability and high reproducibility, and it helps if a biologically plausible hypothesis can link the marker of interest to the outcome. Finally, the screening techniques should be low cost and preferentially modifiable. Many of these issues are being evaluated for the hs-CRP test.