6. What special considerations pertain to imaging biomarkers?

Quality and validity of the measurement as a biomarker depends crucially on the use of a diagnostic imaging device, in a slightly different manner than in routine scanning.

Identification of the ‘objectively measured biomarker characteristic’ with a quantifiable concentration of a specified analyte may be not just impractical, but not even theoretically possible.

Qualification typically includes:

• imaging-pathology correlation in humans and preclinical models, following intervention, dose response, positive and negative control;
• cross-sectional correlation with clinical measures and other biomarkers;
• correlation with outcome.