ARTICLE | Politics & Policy

FDA backs further study of kidney biomarkers

October 22, 2014 3:53 AM UTC

FDA issued its first Letter of Support for two kidney biomarkers identified by the Predictive Safety Testing Consortium (PSTC) of the Critical Path Institute (C-Path).

Elevated levels of the two biomarkers, osteopontin (OPN) and neutrophil gelatinase-associated lipocalin ( NGAL) in urine were associated with renal tubular epithelial degeneration/necrosis in C-Path's animal studies. FDA encouraged investigators to conduct non-clinical and exploratory clinical studies to evaluate the relevance of OPN and NGAL measurements in determining kidney injuries. ...