Imaging in Biomarker Qualification
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Thomas Gwise, FDA  Thomas E Gwise, FDA  *Ian Huang, FDA 

Keywords: biomarker qualification, imaging

Biomarker qualification is FDA’s formalized process of recognizing a biomarker for use in drug development for a specified context of use. Imaging outcomes, can be viewed as biomarkers, and be utilized in the process of drug development. Examples of possible applications include: prognostic, predictive, pharmacodynamic, and surrogate biomarkers. Examples of imaging measurements include standard uptake value (SUVs), vessel stenosis, colonic transit and tumor size metrics. Imaging agents are drugs used in the process for imaging generation such as radioactive tracers, which can help in obtaining interpretable images with good quality. Evaluation of imaging based biomarkers poses unique challenges due to components of variability that are not present in the more common lab-based biomarker tests. Here, we discuss some unique features of imaging biomarkers in terms of context of use, data acquisition, measurement methodology, and statistical methods used for qualification. Examples of biomarker qualification of imaging product and the use of imaging biomarkers in drug applications are presented.