FDA supports C-Path's kidney biomarker

FDA issued a Letter of Support to the Polycystic Kidney Disease Outcomes Consortium of the Critical Path Institute (C-Path) for the use of total kidney volume (TKV) as a prognostic biomarker to select patients for clinical trials of new treatments for autosomal dominant PKD.

FDA encouraged further development of TKV, measured by MRI, CT or ultrasound, in combination with patient factors such as age and estimated glomerular filtration rate (eGFR), to identify patients likely to experience progression of renal dysfunction over the course of a trial. ...