Development of a urine test for the early detection of liver cancer The need to develop an effective method for detecting liver cancer is urgent. HCC, a primary liver cancer, is the third leading cause of cancer deaths worldwide and the fastest rising cancer in US. HCC has a 5-year survival rate of less than 15%, if detected early, the survival rate can be as high as 40%. The survival rate drops significantly, however, to as low as 2% if the cancer has spread to other organs. We have successfully accomplished the proposed milestones from our Phase II award (5R44CA165312-04) to develop an HCC screening test (the JBS HCC test) that can identify 30% more HCC than serum AFP, the current most used biomarker for HCC screening. This phase IIB application is to bridge the gap between our successful accomplishments in the Phase II period and commercialization of the JBS HCC test for HCC screening, so more people with HCC can benefit from early detection. The early detection of HCC is critical for the effective treatment and cure of this disease. Although the JBS test shows great promise to improve liver cancer screening, there are steps (identified as milestones in this application) that need to be taken before the test can reach at-risk patients for HCC. These steps include CLIA certification (Aim 1) so that the test can be marketed as a laboratory developed test (LDT), and filing request for a CPT code for the third party payee reimbursement, and evaluation of performance through a multicenter, blinded validation study to generate data supporting clinical benefit so the test can be considered as a standard of care for HCC screening in at-risk populations (Aim 2), and standardization of urine collection, storage, and transportation, and automation of urine cfDNA isolation to facilitate commercialization (Aim 3). Thus, three specific Aims are proposed to prepare for the launch of the JBS HCC screening test to the market.
The need is urgent to have an effective method for noninvasive detection of early-stage liver cancer, which is the third leading cause of cancer death worldwide and has one of the highest recurrence rates. The current standard methods for screening rely on the serum level of alpha-fetoprotein, which has only ~50% sensitivity. The goal of this project is to facilitate the commercialization of a JBS HCC test to detect early stages of liver cancer by analyzing liver cancer-associated genetic and epigenetic modifications along with serum AFP.
