JBS SCIENCE INC — Department of Health and Human Services SBIR Phase I: 102

Description

Urine DNA Kit for monitoring HCC recurrence This SBIR phase I application is to test the feasibility of developing HCC urine DNA biomarkers to address the critical unmet need for a noninvasive sensitive monitoring tool for early detection of hepatocellular carcinoma HCC recurrence HCC incidence has doubled overall in the past two decades making it one of the fastest growing malignancies in the United States and a leading cause of cancer related deaths globally There is greater than a chance of recurrence of which occurs within years in HCC patients who undergo curative therapy resection transplantation or local ablation thus limiting overall survival Currently post treatment monitoring guidelines are unclear and patients are typically monitored every months by serum AFP and imaging such as ultrasound and MRI for the first years with increasing intervals thereafter JBS Science is pioneering the development of assays detecting HCC urine DNA markers for HCC detection and management This application will apply three already developed and patented short amplicon assays TP T mRASSF A and mGSTP and develop short amplicon assays for additional known HCC hotspot mutations CTNNB and TERT promoter mutations for development of a urine DNA kit for monitoring HCC recurrence This proposal aims to test the feasibility of early detection of HCC recurrence using these five marker assays in patients treated with curative interventions Two aims are proposed Aim is for assay development and Aim is to determine the performance of the HCC urine DNA kit for detection of HCC recurrence as compared to serum AFP We will prospectively collect serial urine samples from at least HCC patients after treatment at follow up office visits from two clinical sites Johns Hopkins University and Thomas Jefferson University for monitoring recurrence Marker values will be determined for each urine sample by our urine DNA kit and analyzed for the performance of JBS urine DNA kit to screen for HCC recurrence alone or in combination with serum AFP In addition we will determine whether the urine DNA biomarker test can detect HCC earlier than current imaging MRI CT scan This proposal will lead to the development of a method that can detect HCC recurrence earlier than the current methods by either replacing or combining AFP with a simple and non invasive urine DNA test This will bring more patients to sophisticated imaging diagnosis such as MRI or CT in a quick and accurate manner in locating the tumor for treatment PUBLIC HEALTH RELEVANCE Liver cancer is leading cause of cancer related deaths globally and one of the most fatal cancers worldwide mainly due to late detection and a high recurrence rate andgt Current post treatment monitoring guidelines are not clear and there is a need to develop an effective method for noninvasive and sensitive monitoring for liver cancer recurrence The goal of this Phase I project is to develop a urine DNA test that can detect liver cancer recurrence earlier than the current methods by analyzing liver cancer associated genetic alterations