ACCURE HEALTH INC — Department of Health and Human Services SBIR Phase I: 102

Description

MAGNETO ELECTRONIC SENSING OF CANCER IN URINE PROJECT SUMMARY ABSTRACT Bladder cancer is the fth most common cancer in the United States and one key challenge for bladder cancer is the high recurrence rate after initial treatment Furthermore a number of medical and environmental conditions are associated with higher incidence of bladder cancer Therefore regular surveillance of bladder cancer is critical in subpopulations to detect disease early prevent relapse and progression and improve overall survival The current gold standard of bladder cancer detection is cystoscopy which is invasive and expensive Existing urine based testing methods for bladder cancer have not been widely adopted in clinical practices either due to low test sensitivity and speci city conventional cytology ELISA or technical complexities long turn around time and high cost RT qPCR sequencing To address these challenges Accure Health proposes to commercialize a non invasive fast affordable and highly accurate diagnostic platform based on integrated magneto electronic sensing iMES of urine exosomes or extracellular vesicles EVs EVs have emerged as a new class of biomarker for cancer management detectable in urine circulation and other body uids These secreted vesicles carry molecular information from their originating cells and capturing this information can provide a representative real time window to monitor tumor burden A variety of EV biomarkers have been investigated to speci cally detect tumor originating EV One critical unmet need to harness the translational potential of EV is to develop more integrated highly sensitive and easy to use clinical systems since puri cation and conventional analytics are often too complex time consuming and expensive In preliminary work we have developed and validated the easy to use and sensitive iMES technology which seems ideally suited for point of care diagnostics for bladder cancer We now propose to further improve the user interface miniaturize the sensor for commercialization and perform correlative benchmarking measurements against accepted gold standards We also plan to develop several smart diagnostic modules including smart device communication and cloud based data management We believe that by connecting patients and doctors through smart devices and cloud based resources patient care and disease management can be signi cantly improved This Phase I proposal will focus on two speci c Aims i Develop a smart iMES platform for rapid and sensitive urine biomarker analysis and ii apply the new iMES platform to screen urinary EVs for bladder cancer detection Successful completion of this Phase I project will result in a product prototype ready for direct analyses of urine samples from bladder cancer patients During a subsequent Phase II we will perform clinical testing with key partners The smart features together with non invasiveness high sensitivity and low cost of this system will allow Accure Health to be in a position to le for Investigational Device Exemption by the end of Phase II which will further strengthen our competitive advantages and value proposition PROJECT NARRATIVE We will develop a new diagnostic platform based on integrated magneto electronic sensing iMES of urine exosomes or extracellular vesicles EVs By integrating miniaturized biosensor technologies and digital healthcare solutions this smart iMES platform will enable non invasive fast affordable and highly accurate diagnosis of bladder cancer in point of care settings and facilitate remote patient monitoring and personalized treatment