TYMORA ANALYTICAL OPERATIONS LLC — Department of Health and Human Services SBIR Phase I: 102

Description

PROJECT SUMMARY Profiling of Extracellular VesiclesEVhas emerged as a highly promising field for discovery of tumor relevant biomarkers from biofluidssuch as bloodurineCSF or othersThe use of biofluid EVs offers numerous advantages in clinical settingincluding non invasive collectiona suitable sample source for longitudinal disease monitoringbetter screenshot of tumor heterogeneityhigher stability and sample volumesfaster processing timeslower rejection rates and costs compared to their tissue counterpartDespite the immense potentialthe data on EV phosphoproteomes are virtually non existentIn this NIH SBIR Fast Track studywe will further develop a novel urine analysis platform based on EVtrap beads for complete capture of extracellular vesicles and in house developed proteome extraction and analysis approach into highly efficient and reproducible method for discovery and detection of cancer biomarkersWe have already utilized this approach to generate a new panel of protein phosphoprotein markers from urinary EVs for sensitive and non invasive detection and monitoring of bladder cancerDuring this projectthe discovered biomarkers panel will be validated and refined to demonstrate clinical utilityThe following aims will be completed in the Phase I of the proposalAimDevelop and optimize EVtrap for large scale and high throughput EV isolationAimDetermine the feasibility of the current bladder cancer biomarkers and refine the panelThe following aims will be completed in the Phase II of the proposalAimAdapt EVtrap to an existing automated device for high throughput EV capture and cargo analysisAimValidate and standardize the final panel for clinical utilityBy the completion of this projecta biomarker discovery platform from urine will be developedand bladder cancer monitoring 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 Protein phosphorylation relates to the onset and development of many cancer types and a highly efficient technology for phosphorylation analysis is critical for cancer researchThis NIH SBIR Fast Track project will support the effort to develop an innovative protein phosphoprotein biomarker discovery and detection platform from urinewith particular focus on bladder cancer diagnostics