FDA backs further study of kidney biomarkers

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. ...