Development of a urine test for the early detection of liver cancer

用于肝癌早期检测的尿液检测方法的研制 迫切需要开发一种有效的方法来检测肝癌。肝细胞癌，一种原发肝脏 癌症是全球第三大癌症死亡原因，也是美国上升最快的癌症。 肝细胞癌的5年存活率不到15%，如果及早发现，存活率可以高达 40%。然而，如果癌症已经扩散到，存活率显著下降到2% 其他器官。我们已经成功地完成了第二阶段提出的里程碑。 获奖(5R44CA165312-04)开发一种肝细胞癌筛查测试(JBS肝细胞癌测试)，可以识别 比目前筛查肝细胞癌最常用的生物标志物血清甲胎蛋白高30%。这一阶段 申请IIB是为了弥合我们在第二阶段取得的成功成就之间的差距 以及JBS肝细胞癌筛查检测的商业化，这样更多的肝细胞癌患者可以 从早期发现中受益。肝细胞癌的早期发现是有效治疗和治疗的关键。 治愈这种疾病的方法。尽管JBS检测显示出改善肝癌筛查的巨大希望， 在测试之前需要采取一些步骤(在本应用程序中标识为里程碑) 可以接触到肝细胞癌的高危患者。这些步骤包括CLIA认证(目标1)，以便测试 可作为实验室开发的测试(LDT)进行销售，并提交CPT代码申请 第三方受款人报销，并通过多中心、盲目评估业绩 验证性研究，以生成支持临床益处的数据，因此该测试可被视为 高危人群肝癌筛查护理标准(目标2)和尿液标准化 尿液cfDNA的收集、储存和运输，以及自动化分离，以便于 商业化(目标3)。因此，提出了三个具体目标，为启动 JBS肝癌筛查试验推向市场。

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.