We have previously found that nCD64 strongly correlates with endoscopic-defined CD severity14 with FCGRIA expression >3-fold higher in the intestinal tissue of treatment-naive, newly diagnosed pediatric CD compared with controls.13, 29 Although nCD64 was shown to be effective in identifying silent CD (asymptomatic patients with ongoing intestinal inflammation who are at high risk of clinical relapse),15 we have not analyzed nCD64 as a companion diagnostic for anti-TNF therapy. This evidence concerns the gene TNF and Cowden disease.