Ascent Bio-Nano Technologies Inc — Department of Health and Human Services SBIR Phase II: 400

Description

Project Summary Exosomes are extracellular vesiclesnmfound in nearly all biological fluidsincluding bloodurinesalivaand cerebrospinal fluidIn recent years they have emerged as a potentially powerful tool for biomedical researchbiomarker discoverydisease diagnosticsand health monitoringExosomes perform diverse cellular functions such as intercellular communicationantigen presentationand transfer of proteinsmRNAand miRNAThe proteins found inside of exosomes are characteristic of their cell of origin and many exosomal proteins are linked to diseases such as Alzheimerandapos scancerand diseases of the kidneyliverand placentaExosomes possess advantages over other circulating biomarkers in that they are highly abundantthousands to billions per microliter of biofluidcan be collected noninvasively during early stages of disease developmentand are very durablepreserving their content through multiple freeze and thaw cyclesWhile many discoveries have been made in identifying new exosomal protein biomarkersthe difficulties involved in the isolation of exosomes have prevented their widespread use in biomedical research and clinical applicationsAs a resultthere exists a critical need in the research and clinical communities for a simplerapidbiocompatibleand effective approach for isolating exosomes form biological fluids or in vitro cell cultureIn this SBIR projectwe will address this unmet need by developing and commercializing acoustofluidici ethe fusion of acoustics and microfluidicstechnologies for point of careautomated exosome isolationWe name our acoustofluidic exosome solation technology ExoSOUNDIn our Phase I type Randamp D effortsAscent has successfully demonstrated the utility and feasibility of the proposed devices by meeting or exceeding the target values of each of the three key parameters identified in the Measures of SuccessIn Phase IIour commercialization activities will improve performance of the disposable ExoSOUND chipsdevelop self containedbeta testingready prototypesand validate their performance with end usersThe proposed ExoSOUND technology will have the following featuresAutomated exosome isolationwhich enables excellent biohazard containment and short processing timee gandltmin to isolate exosomes directly fromL undiluted bloodwhich is significantly less than that of the benchmark technologieshoursHigh exosome yieldandgtin comparison to the benchmark technologiesBetter ability to isolate biologically active and morphologically intact exosomes than the benchmark technologiesLow driving voltageandltVwhich simplifies electronics and power requirementsandLow costCOGS for permanent equipmentandlt $in comparison to the benchmark technologiesequipment cost$$With these featureswe expect that once demonstratedthe proposed ExoSOUND technology will not only become a more compactaffordableconvenient to use replacement to the existing exosome isolation approachesbut also fulfill many unmet needs in fundamental biomedical research and clinical applications Project Narrative Cell derived vesicles such as exosomes are present in almost all biological fluidsThey have been recognized to be valuable for both biomedical research and clinical applicationsThe proposed project is to develop point of care devices that can perform automatedhigh yieldhigh purityhigh biocompatibility exosome isolationThese devices will help expedite exosomerelated biomedical research and aid in the discovery of new exosomal biomarkers