TABLE 1.

Regulatory Ready Checklist for FC and CRP as Pharmacodynamic/Response Biomarker in CD

	Fecal Calprotectin	Serum C-Reactive Protein
Biological Plausibility	Expression in neutrophils, a primary inflammatory component of CD	Increases in blood with inflammation
Association with CD	Increases with CD severity	Increases with CD severity
Assay status	FDA cleared diagnostic assays are available	FDA cleared diagnostic assays are available
Improvement over current tools	Decreased cost and less invasive than ICS	Decreased cost and less invasive than ICS
Clinical Data	Significant clinical validation data available (~50 clinical trials found in clinicaltrials.gov)	Significant clinical validation data available (~50 clinical trials found in clinicaltrials.gov)
Information gaps for qualification	• Ramifications of variable baseline must be understood • Relevant cutoff values must be defined • Measurement methodology must be evaluated and standardized	• Relevant cutoff values must be defined • Ramifications of biomarker sensitivity and specific on utility must be understood