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. Author manuscript; available in PMC: 2015 Mar 1.
Published in final edited form as: Circ Cardiovasc Imaging. 2014 Mar;7(2):390–397. doi: 10.1161/CIRCIMAGING.113.000470

Table 1.

Principles for evaluation of a new biomarker, as suggested by Hlatky et al.15 in 2009 AHA guidelines of evaluation of a new biomarker.

  1. Proof of concept: Do novel biomarkers differ between subjects with and without outcomes?

  2. Prospective validation: Does the novel biomarker predict the development of future outcomes in a prospective cohort or nested case-control study?

  3. Incremental value: Does the novel biomarker add predictive value to established, standard risk markers?

  4. Clinical use: Does the novel risk marker change predicted risk sufficiently to change recommended therapy?

  5. Clinical outcomes: Does use of the novel risk marker improve clinical outcomes, especially when tested in a randomized clinical trial?

  6. Cost-effectiveness: Does use of the marker improve clinical outcomes sufficiently to justify the additional costs of testing and treatment?