BioCentury
ARTICLE | Politics & Policy

FDA grants first qualification of a clinical safety biomarker

October 26, 2018 11:04 PM UTC

FDA qualified a group of kidney injury biomarkers from the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium (BC) and the Critical Path Institute (C-Path) Predictive Safety Testing Consortium (PSTC), marking the first qualification of a clinical safety biomarker.

The qualification applies to a single composite measure of six urine biomarkers that can now be used in Phase I trials in conjunction with traditional measures of kidney function to aid in detecting treatment-induced acute kidney tubular injury in healthy volunteers...