Phase II Amount
$2,481,780
Alzheimer's disease (AD) is a crippling, terminal neurodegenerative illness that affects an estimated 5.5 millionpeople in the United States and approximately 10% of the population over the age of 65. Early symptoms of thedisease include impairment in recent memory, difficulties with expressive language, and behavioral changesincluding depressed mood. Symptoms gradually worsen over time, ultimately leading to dementia and a loss ofbodily functions. Currently there is no sensitive, objective diagnostic test for the early diagnosis of AD, making itdifficult for physicians to properly screen for the disease and failing to diagnose patients that may be positive forAD. While advances have been made in medical imaging for AD, they are extremely costly and have limiteddiagnostic accuracy. In recent years, neuron-derived exosomes (30-150 nm extracellular vesicles) haveemerged as a promising biomarker for diagnosing AD. Neuron-derived exosomes found in circulation can providea simple, non-invasive means of monitoring the health of the central nervous system. Accumulating evidencesuggests that neuron-derived exosomes may play a crucial role in the pathology of AD by helping to spreadabnormal, potentially disease-causing, misfolded proteins throughout the brain. Preliminary studies have shownthat by analyzing the number of neuron-derived exosomes and their molecular cargo, early-stage AD patientscan be distinguished from healthy controls, as well as patients with other neurological diseases. Whileresearchers have made progress in identifying neuron-derived exosomal proteins and RNAs, difficultiessurrounding the isolation and analysis of exosomes have prevented their widespread use as a biomarker for AD.Currently, there are no commercially available products capable of simultaneously isolating and analyzingneuron-derived exosomes. The objective of this SBIR project is to overcome the limitations of existing ADdiagnostic technologies and address the unmet needs in the market by developing and commercializing anautomated, high-purity, high-yield, biocompatible exosome isolation and accurate AD biomarker detection usingacoustofluidic (i.e., the fusion of acoustics and fluid mechanics) separation and electrochemical detectiontechnologies. During our work on the Phase I project, we successfully demonstrated the utility and feasibility ofthe proposed exosome isolation and analysis device for AD diagnosis by meeting or exceeding the target valuesfor each of the four key parameters identified in the Measures of Success. In Phase II, our commercializationactivities will improve the performance of the acoustofluidic chips, develop self-contained, beta-testing-readyprototypes, and validate their performance with end users. With its advantages in automation, speed, precision,and accuracy, the proposed acoustofluidic technology has the potential to greatly simplify and revolutionize thediagnosis of AD. The result will be a highly sensitive liquid biopsy that will provide a comprehensive molecularsignature for AD, thus significantly improving diagnostic accuracy past existing methods and providing deeperinsight in the pathophysiology of the disease.
Public Health Relevance Statement: Project Narrative
Alzheimer's disease is a devastating terminal disease with no cure, and rapidly increasing worldwide prevalence,
posing a global crisis to the healthcare economy. There is a critical need to identify at earlier stages of the
disease to better develop preventative and treatment strategies, however there has yet to be a standard test that
is easy to admit with a high accuracy at early stages of the disease. The objective of this proposed project is to
develop and commercialize an acoustic-based liquid biopsy that will serve as a platform for conducting simple
blood tests with rapid processing times and high accuracy for a large suite of exosomal based biomarkers for
Alzheimer's disease present in the patients' blood - an industry first.
Project Terms: | 