Table 3. Phases of biomarker development
| Adapted from reference 7. |
| 1a. Initial preclinical discovery |
| discovery biomarker on tissue or serum samples |
| 1b. Confirmation of preclinical discovery |
| Validate biomarker on same type of samples |
| Promising direction identified and prioritized |
| 2. Clinical assay development and validation |
| set up clinical assay and test on existing samples |
| clinical assay detects established disease |
| 3. Retrospective longitudinal |
| test biomarker in completed clinical trial |
| detects disease early before it becomes clinically obvious |
| “screen positive” rule is determined; evaluate sensitivity/specificity |
| 4. Prospective screening |
| Use biomarker to screen population |
| extent and characteristics of disease detected by test |
| false referral rate identified |
| 5. Disease control |
| impact of screening on reducing the burden of disease |