Development of novel methods and reagents for surveillence of prion infection

Adlyfe Inc. has developed a highly sensitive fluorescence based test, called the Misfolded Protein Diagnostic (MPD) Assay, for the misfolded prion protein associated with infectivity. The femtomolar sensitivity of the test enables the presymptomatic detection in blood, which can be performed ante mortem in routine surveillance of live animals and in blood screening of the human blood supply. The MPD Assay does not rely on antibodies but mimics the folding activity of prions utilizing a target binding peptide. The amplification of the signal through nucleation of folding of other added binding peptides, allows for the extreme sensitivity of the detection method to be realized. This has been demonstrated in controlled in vitro biophysical studies, controlled models of disease in hamsters and mice, and in endemic disease with blood samples from scrapie sheep, BSE-infected cows and monkey and human sCJD. Current protocols and methodology have been geared toward laboratory bench execution of the MPD assay. Here, we propose to move this exciting new technology forward to a more robust integrated assay system that will ultimately encompass software for data analysis and reporting.