FDA supports C-Path's AD, PD biomarkers

FDA issued Letters of Support to the Coalition Against Major Diseases (CAMD) consortium of the Critical Path Institute (C-Path) for the use of five biomarkers to help select early stage Parkinson's and Alzheimer's disease patients for clinical trials.

The PD biomarker tests for activity of dopamine transporter via single-photon emission computed tomography (SPECT) imaging. FDA said patients with low transporter activity are more likely to show subsequent clinical decline. ...