A novel diagnostic Kit for Hepatocellular Carcinoma

一种新型肝细胞癌诊断试剂盒

• 批准号: 10670881
• 负责人: Xuanyong Lu
• 金额: $ 128.9万
• 依托单位: IMCARE BIOTECH, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10670881
• 关键词: Address; Award; Biological Markers; Biopsy; Biotechnology; Blood; Blood specimen; Cessation of life; Chronic; Chronic Hepatitis B; Cirrhosis; Clinical; Clinical Research; Data; Data Analyses; Development; Diagnosis; Diagnostic Reagent Kits; Disease; Early Diagnosis; Early treatment; Enrollment; Ensure; Enzyme-Linked Immunosorbent Assay; Excision; Goals; Hepatitis B Virus; Hepatitis C; Image; Imaging technology; Incidence; Individual; Letters; Liver Cirrhosis; Liver diseases; Longitudinal Studies; Magnetic Resonance Imaging; Malignant Epithelial Cell; Malignant neoplasm of liver; Marketing; Medical Device; Monoclonal Antibodies; Outcome; Pancreatitis; Patients; Performance; Phase; Physicians; Primary carcinoma of the liver cells; Prognosis; Proteins; Prothrombin; Radiofrequency Interstitial Ablation; Recommendation; Relative Risks; Research Personnel; Risk; Risk Assessment; Sample Size; Screening for Hepatocellular Cancer; Sensitivity and Specificity; Serine Proteinase Inhibitors; Serum; Small Business Innovation Research Grant; Specificity; Surveillance Methods; Survival Rate; Technology; Testing; Time; Universities; Use Effectiveness; Viral; alpha-Fetoproteins; chronic liver disease; commercialization; cost; curative treatments; design; diagnostic platform; disorder risk; effective therapy; high risk; improved; liver transplantation; medical schools; minimally invasive; novel diagnostics; phase 2 study; primary endpoint; prospective; secondary endpoint; surveillance study; tool; tumor; ultrasound; Address; Award; Biological Markers; Biopsy; Biotechnology; Blood; Blood specimen; Cessation of life; Chronic; Chronic Hepatitis B; Cirrhosis; Clinical; Clinical Research; Data; Data Analyses; Development; Diagnosis; Diagnostic Reagent Kits; Disease; Early Diagnosis; Early treatment; Enrollment; Ensure; Enzyme-Linked Immunosorbent Assay; Excision; Goals; Hepatitis B Virus; Hepatitis C; Image; Imaging technology; Incidence; Individual; Letters; Liver Cirrhosis; Liver diseases; Longitudinal Studies; Magnetic Resonance Imaging; Malignant Epithelial Cell; Malignant neoplasm of liver; Marketing; Medical Device; Monoclonal Antibodies; Outcome; Pancreatitis; Patients; Performance; Phase; Physicians; Primary carcinoma of the liver cells; Prognosis; Proteins; Prothrombin; Radiofrequency Interstitial Ablation; Recommendation; Relative Risks; Research Personnel; Risk; Risk Assessment; Sample Size; Screening for Hepatocellular Cancer; Sensitivity and Specificity; Serine Proteinase Inhibitors; Serum; Small Business Innovation Research Grant; Specificity; Surveillance Methods; Survival Rate; Technology; Testing; Time; Universities; Use Effectiveness; Viral; alpha-Fetoproteins; chronic liver disease; commercialization; cost; curative treatments; design; diagnostic platform; disorder risk; effective therapy; high risk; improved; liver transplantation; medical schools; minimally invasive; novel diagnostics; phase 2 study; primary endpoint; prospective; secondary endpoint; surveillance study; tool; tumor; ultrasound

PROJECT SUMMARY ImCare Biotech is seeking to commercialize Seravue®, an ELISA-based diagnostic system that is able to identify both early and late stage Hepatocellular Carcinoma (HCC) with high sensitivity and specificity. With NCI- supported Phase I and II SBIR awards plus internal and external investor support, ImCare completed the technical development of the Seravue® product and now requests Phase IIB SBIR support to conduct a prospective clinical study required for a 510(k) filing and subsequent regulatory clearance. Commercialization of Seravue® has the potential to substantially improve early detection of HCC in patients undergoing surveillance due to high-risk conditions, thereby ensuring timely, effective treatment and greatly increasing survival. HCC, the most common and deadliest form of liver cancer, has a 5-year survival rate of less than 15% and is directly responsible for hundreds of thousands of deaths worldwide each year. HCC is typically diagnosed at a late stage when treatments are largely ineffective, resulting in poorer prognosis, but early diagnosis and treatment can increase 5-year survival rates to >70%. Thus, individuals known to be at high risk for HCC—including patients with liver cirrhosis or chronic hepatitis B/C—undergo HCC surveillance every 3 to 6 months to improve the chances of catching the disease early. Current surveillance methods have significant drawbacks including cost, burden, poor detection of early disease, and inadequate sensitivity and specificity. To address the need for a better surveillance tool, we developed Seravue®, a minimally-invasive, accurate, consistent, and inexpensive test for Liver Cancer-Serine Protease Inhibitor Kazal (LC-SPIK), a protein specifically secreted by HCC cells. In Phase I and Phase II studies, ImCare confirmed two critical features of Seravue®: 1) It distinguishes HCC from other liver diseases, non-liver diseases, and healthy subjects and 2) it is significantly more sensitive and specific than alpha fetoprotein (AFP), the most common biomarker test for HCC. In this Phase IIB SBIR, ImCare proposes to conduct a clinical study to support a 510(k) filing for the clearance of Seravue® as class II medical device. Aim 1. Demonstrate the feasibility and effectiveness of using serum levels of LC-SPIK to assess the risk of developing HCC for patients with chronic liver disease. Per FDA guidance, the blood biomarker DCP will be used as the primary predicate. Primary Endpoints: Sensitivity and specificity compared to DCP. Secondary Endpoint: Calculated relative risk of developing HCC compared to DCP. Aim 2. Pursue CMS reimbursement and submit a 510(k) application. Milestones: 1) Additional requirements for CMS reimbursement identified and 2) 510(k) filing submitted. Impact: Successful completion of these milestones is expected to support FDA clearance of Seravue®, which will provide an early detection and surveillance tool for HCC that provides better efficacy, lower cost, and lower burden than current tools. Commercialization of Seravue® is expected to save lives by increasing early detection.

项目摘要 Imcare Biotech正在寻求商业化Seravue®，这是一种基于ELISA的诊断系统，能够 确定具有高灵敏度和特异性的早期和晚期肝细胞癌（HCC）。与nci- 支持的第一阶段和第二阶段SBIR奖以及内部和外部投资者支持，IMCARE完成了 Seravue®产品的技术开发，现在请求IIB SBIR阶段支持进行 510（k）提交和随后的监管清除所需的前瞻性临床研究。商业化 Seravue®的潜力有可能大大改善正在接受的患者的HCC的早期检测 由于高风险条件而导致的监视，从而确保及时，有效的治疗 增加生存。 HCC是肝癌最常见和最致命的形式，其生存率为5年 不到15％，直接造成全球数十万人死亡。 HCC是 通常在治疗基本无效的后期被诊断出，导致预后较差，但 早期诊断和治疗可以将5年的存活率提高到> 70％。那个人已知很高 HCC的风险 - 包括肝硬化或B/C慢性肝炎的患者每3次监测 到6个月以提高早期疾病的机会。当前的监视方法具有重要的 缺点包括成本，烧伤，对早期疾病的发现不良以及灵敏度和特异性不足。到 满足了更好的监视工具的需求，我们开发了Seravue®，一种微创，准确， 肝癌蛋白酶抑制剂Kazal（LC-SPIK）的一致且廉价的测试，一种蛋白质 特别由HCC细胞分泌。在第一阶段和第二阶段研究中，IMCARE确认了两个关键特征 Seravue®：1）它将HCC与其他肝病，非肝病和健康受试者区分开 比α胎儿蛋白（AFP）明显更敏感和特异性，这是最常见的生物标志物测试 HCC。在此阶段IIB SBIR中，IMCARE提出了一项临床研究，以支持510（k） Seravue®作为II类医疗设备的清除。目标1。证明使用的可行性和有效性 LC-SPIK的血清水平以评估患有慢性肝病患者HCC的风险。每fda 指导，血液生物标志物DCP将用作主要谓词。主要终点：灵敏度和 与DCP相比。次要终点：与DCP相比，开发HCC的相对风险计算出来。 目标2。追求CMS报销并提交510（k）申请。里程碑：1） 已确定的CMS报销和2）510（k）提交的申请。影响：成功完成这些里程碑 预计将支持Seravue®的FDA清除率，该清除将提供早期检测和监视工具 对于HCC，比当前工具提供了更好的效率，更低的成本和更低的燃烧。商业化 Seravue®有望通过增加早期检测来挽救生命。