CAPTIS DIAGNOSTICS — Department of Health and Human Services SBIR Phase I: 102

Description

SUMMARY Abstract Cancer is one of the leading causes of death in USIt is estimated that there were aboutdeaths from cancer inwhich was more thanpeople per dayThe high mortality rate is a direct result of lack of effective early stage clinical diagnosis method and therapeutic stratificationIf cancer can be effective detected early and treated with right therapythe average five years relative survival rate would greatly increaseExtracellular vesiclesEVsbilayered nano sized vesicles that are found in all bodily fluidsare emerging as a appealing type of cancer biomarker for non invasive cancer diagnosis and therapeutic stratificationEVs would provide significant potential benefit for cancer patients that need repetitive tissue biopsyFor examplesolid tumors are not accessible in aboutof advanced or metastatic non small cell lung cancerNSCLCpatientsTo unleash EVsgreat potential in clinical applicationsrapid and efficient isolation of EVs is a prerequisiteHowevermost of current EVs isolation approaches cannot meet the need in clinical settings due to inherent shortcomingse glengthy procedurelow yieldand low throughputAdditionallyin terms of clinical application of EV in cancer molecular analysisthere is no FDA approved EV based diagnostic tools availableCaptis Diagnostics has developed a new proprietary lipid nanoprobeLNPsystem that can isolate EVs directly from samplesUS Application Noand International Application NoPCT USThe LNP is capable of efficiently isolating EVs from cell culture media or human body fluidse gplasmausing a rapid workflow and inexpensive reagentsIn this proposalwe propose to develop and commercialize our lipid nanoprobe system invention for EV isolation from plasma and further develop EV DNA analysis platform for targeted therapy selection in NSCLC patientsFor AimCaptis Diagnostics will optimize and validate of the LNP technology to develop it to a research kit for EV isolation that can achieve high EV isolation efficiencysimple and short workflowand adaption to complex bodily fluids samplessuch as blood plasmaAimwill develop a proof of concept clinical assay for targeted therapy selection in NSCLC patients by combining mutation detection by digital droplet PCRddPCRwith LNP EV isolationSuccessful completion of these Aims will yield a proprietary advanced technology and position Captis Diagnostics to pursue clinical validation of the EV in clinical assay for targeted therapy selection for cancer patientsPhase II activities will be focused on the clinical performance of NSCLC targeted therapy selection assaysin which the EV isolation technology will be tested with samples from cancer patients to validate its clinical utility Narrative Cancer is one of the leading causes of death in USIt is estimated that there were aboutdeaths from cancer inwhich was more thanpeople per dayThe high mortality rate is a direct result of lack of effective early stage clinical diagnosis method and therapeutic stratificationFor exampletissue tumors are not accessible in aboutof advanced or metastatic non small cell lung cancerNSCLCpatientsExtracellular vesiclesEVsbilayered nano sized vesicles that are found in all body fluidsare emerging as an appealing type of cancer biomarker for non invasive cancer diagnosis and therapeutic stratificationTo unleash EV s great potential in clinical applicationsrapid and efficient isolation of EVs is a prerequisiteWe propose to develop and commercialize our lipid nanoprobe invention for EV isolation from plasma and further develop an EV DNA analysis platform for targeted therapy selection in NSCLC patients!