. Author manuscript; available in PMC: 2016 Aug 11.

Published in final edited form as: Rheum Dis Clin North Am. 2013 Jul 16;39(4):833–853. doi: 10.1016/j.rdc.2013.05.001

Table 3.

Phases of biomarker discovery, translation, and validation

Phase	Terminology	Action Steps
Phase 1	Preclinical discovery	Discover biomarkers in tissues or body fluids Confirm and prioritize promising candidates
Phase 2	Assay development	Develop and optimize clinically useful assay Test on existing samples of established disease
Phase 3	Retrospective study	Test biomarker in completed clinical trial Test if biomarker detects the disease early Evaluate sensitivity, specificity, receiver-operating characteristic
Phase 4	Prospective screening	Use biomarker to screen population Identify extent and characteristics of disease Identify false referral rate
Phase 5	Disease control	Determine impact of screening on reducing disease burden

From Devarajan P. Proteomics for biomarker discovery in acute kidney injury. Semin Nephrol 2007;27(6):637–51; with permission.