Official websites use .gov
A
.gov website belongs to an official
government organization in the United States.
Secure .gov websites use HTTPS
A lock (
) or https:// means you've safely
connected to the .gov website. Share sensitive
information only on official, secure websites.
Phases of Biomarker Validation for Early Detection
| Phase of Development | Definition |
|---|---|
| I | Identify potential biomarkers in a preclinical setting. |
| II | Assess the ability of the assay to distinguish between cases and controls. |
| III | Analyze the ability of the assay to analyze preclinical disease. |
| IV | Assess operating characteristics of biomarker‐based screening in the target population. |
| V | Assess the impact of screening on cancer mortality. |
