The U.S. Food and Drug Administration’s (FDA’s) Biomarker Qualification Program provides a framework for the development and regulatory acceptance of biomarkers for use in drug development programs. FDA works with external stakeholders to develop and qualify measurable and reliable biomarkers for a specific use in drug development.
Once qualified, the biomarker information is made publicly available and may be used in multiple drug development programs under its qualified context of use (COU).
Source: US FDA
CERID researchers are monitoring a biomarker to indicate the presence and amount of Plasmodium falciparum in erythrocytes.