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Copyright ©2014 Baishideng Publishing Group Inc.
World J Gastroenterol. Oct 14, 2014; 20(38): 13767-13774
Published online Oct 14, 2014. doi: 10.3748/wjg.v20.i38.13767
Table 4 Biomarker development process
Phase No.AimDetail
Phase 1Preclinical ExploratoryPromising directions identified
Phase 2Clinical Assay and ValidationClinical assay detects established disease
Phase 3Retrospective LongitudinalBiomarker detects disease early before it becomes clinical and a “screen positive” rule is defined
Phase 4Prospective ScreeningExtent and characteristics of disease detected by the test and the false referral rate are identified
Phase 5Cancer ControlImpact of screening on reducing the burden of disease on the population is quantified