Alzheimer’s disease is the most common form of dementia, affecting approximately 5.8M people in the U.S. It is estimated that without effective therapies, the burden of this disease is predicted to increase from $172 billion in 2010 to a trillion dollars by 2050.

One of the critical challenges in developing therapies against Alzheimer’s disease is the lack of non-invasive objective blood-based tests for proteins associated with Alzheimer’s, called biomarkers. Today, detection these biomarkers requires lumbar puncture, a highly invasive and risky procedure, to collect cerebrospinal fluid (CSF) as a sample. Recently, it was discovered that the same proteins found in CSF could also be found on exosomes, which are small biovesicles that serve as messengers in cell-to-cell communications in the body. Once released by brain cells, exosomes cross the blood-brain barrier, disseminating into many biofluids, including CSF and blood.

Existing methods of analysis of the exosomes require laborious multistep workflows and expensive equipment, which prevents them from being commercially viable for high-throughput applications, such as drug development.

The Verita platform, developed by Biological Dynamics, enables a fully automated single-step on-chip capture and analysis of proteins on the surface of exosomes.  It has the potential to become the first platform to offer standardized testing for Alzheimer’s biomarkers at a high throughput.

This proposal outlines key activities needed to design a multi-biomarker testing panel for the detection of 10 of the most promising, to date, Alzheimer’s biomarkers on exosomes.  The panels will be evaluated on how well they detect the biomarkers of interest as well as on feasibility for use in commercial drug development for patient selection, the measurement of the intended effects of drugs, and the provision of evidence on the effectiveness of therapies.