TYMORA ANALYTICAL OPERATIONS LLC — Department of Health and Human Services SBIR Phase I: N

Description

PROJECT SUMMARY Almostmillion Americans currently live with Alzheimerandapos s diseaseADand this number is projected to increase tomillion byThe consensus is arising in the field that in order to treat AD effectivelyearly detection at the MCI stage is a mustThusthere is a critical need for a novel minimally invasive and cost effective diagnostic assay capable of such early detectionCell secreted extracellular vesiclesEVsrecently gained significant attention in the fields of liquid biopsy and AD researchWithin the scope of biomarker detectionEVs offer numerous benefits for clinical analysisincluding non invasive collectiona suitable sample source for longitudinal disease monitoringability to cross the blood brain barrierhigher stability and sample volumesfaster processing times and lower costMultiple reports linked EVs to neurodegeneration and have been able to couple exosomal load in CSF to AD progressionHoweverthe analysis of plasma exosomes and other EV has not really been possible for early AD detectionThe procedures for plasma biomarker analysis are very long and cumbersome due to extremely low target levels and high background of free plasma proteinsIn order to enable better biomarker discovery and AD diagnosisa more reliable and efficient approach is neededcapable of enriching potential AD associated proteins with higher purityIn this NIH SBIR Phase I studywe will develop a novel method for fast and reproducible capture and isolation of EVs with andgtrecovery yield and andgtpurity from plasma samplesWe propose to implement this EV capture approach to detect and quantify the presence of common AD markersamyloidp tauin plasma EVsand for discovery of new protein and phosphoprotein biomarkers in plasma EVsWe will also correlate and match their levels in CSF EVs and as soluble proteins to evaluate the clinical relevance of using plasma EVs as the source for diagnosticsThe following aims will be completed in the Phase I of the proposalAimDevelop and validate the EVtrap method for plasma EV isolation and purificationAimImplement EVtrap for detection of common AD biomarkers in plasma and CSF exosomesAimDevelop EVtrap for discovery of plasma exosome proteins and phosphoproteins as new AD biomarkersBy the completion of this projectEVtrap capture beads method will be optimizedan AD biomarker discovery platform from plasma EVs will be developedand a minimally invasive early Alzheimerandapos s disease detection assay will be validated that can overcome the limitations of current approachesand thus could have an enormous public health impact and market potential PROJECT NARRATIVE Early non invasive detection of Alzheimerandapos s disease is the number one priority for effective treatmentHoweverno effective wide spread early diagnostics assay is currently availableThis NIH SBIR Phase I project will support the effort to develop a new minimally invasive blood based diagnostic assay for early Alzheimerandapos s disease detection