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Rockville, MD, United States

Patent
Adlyfe Inc. | Date: 2014-09-12

The invention provides methods and kits for detecting conformationally altered proteins and prions in a sample. In one embodiment, the conformationally altered proteins and prions are associated with amyloidogenic diseases.


Grant
Agency: Department of Defense | Branch: Army | Program: SBIR | Phase: Phase II | Award Amount: 750.00K | Year: 2007

The prion disease process involves a conformational change in the prion protein that in turn can serve as the basis for an early detection, diagnostic, prognostic and screening assay. The Misfolded Protein Diagnostic (MPD) Assay detects infectivity in a crude sample through the use of labeled Pronucleon peptides that undergo conformational change in the presence of the misfolded infectious prion protein. The conformational peptide change is propagated throughout the ensemble of sequence specific Pronucleon peptides in the reaction via a nucleation event resulting in an amplification of signal. Preliminary data supports the simplicity and exquisite sensitivity of this non-immunological approach to infectious prion protein detection. Level of detection has been determined to be near 1 infectious dose for titered murine sCJD plasma samples. During Phase I funding, the MPD Assay has been under optimization with keen focus on defining the positive controls for the assay as well as looking at variability between normal human plasma samples to better define the threshold of detection. With continued funding we propose to define and further optimize the assay reagents and metrics into a platform system that can be reduced to a high-throughput, small volume automated format.


Grant
Agency: Department of Defense | Branch: Army | Program: SBIR | Phase: Phase I | Award Amount: 0.00 | Year: 2005

Blood loss due to uncontrolled hemorrhage is a major contribution to at least 90% of the combat death before reaching the field hospital. The ability to control heavy bleeding in the injured soldier is critical and will vastly improve the survival outcome in the theater. Furthermore, complications from uncontrolled bleeding in the microvasculature contribute significantly to increased morbidity. Finally, disruption of the vasculature during trauma can limit healing and soft tissue repair and regenerative phases once bleeding has subsided. Our goal is to address these critical aspects of combat casualty care, providing first echelon care that will have significant impact on acute events as well as improved outcome late into the time course of treatment and recovery. Our approach to developing next generation hemostatic products for combat casualty care is to exploit the natural properties of platelets which contain both hemostatic and healing properties.


Grant
Agency: Department of Defense | Branch: Army | Program: SBIR | Phase: Phase II | Award Amount: 750.00K | Year: 2005

Blood loss due to uncontrolled hemorrhage is a major contribution to at least 90% of the combat death before reaching the field hospital. The ability to control heavy bleeding in the injured soldier is critical and will vastly improve the survival outcome in the theater. Furthermore, complications from uncontrolled bleeding in the microvasculature contribute significantly to increased morbidity. Finally, disruption of the vasculature during trauma can limit healing and soft tissue repair and regenerative phases once bleeding has subsided. Our goal is to address these critical aspects of combat casualty care, providing first echelon care that will have significant impact on acute events as well as improved outcome late into the time course of treatment and recovery. Our approach to developing next generation hemostatic products for combat casualty care is to exploit the natural properties of platelets which contain both hemostatic and healing properties.


Grant
Agency: Department of Defense | Branch: Army | Program: SBIR | Phase: Phase I | Award Amount: 100.00K | Year: 2005

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.

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