A novel diagnostic Kit for Hepatocellular Carcinoma

一种新型肝细胞癌诊断试剂盒

• 批准号: 10490412
• 负责人: Xuanyong Lu
• 金额: $ 128.38万
• 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/10490412
• 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; Image; Imaging technology; Incidence; Individual; Letters; Liver Cirrhosis; Liver diseases; Longitudinal Studies; Magnetic Resonance Imaging; Malignant Epithelial Cell; Malignant neoplasm of liver; 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; Sample Size; 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; base; 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试图将Seravue®商业化，这是一种基于ELISA的诊断系统。 识别具有高灵敏度和特异性的早期和晚期肝细胞癌（HCC）。 IMCARE支持的I和II阶段SBIRD以及内部和外部投资者的支持，为您完成了 Servue®产品的技术开发，并请求IIB SBIR阶段支持以进行 前瞻性临床研究需要510（k）提交和随后的监管清除 Seravue®的潜力有可能证明正在接受的患者的HCC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 增加的生存率。 不到15％，每年在全球成千上万的死亡直接反应。 通常在治疗效率更大的后期被诊断出，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％。 肝硬化或慢性肝炎B/c -dergo HCC监测的风险 直到6个月，请尽早捕获疾病的捕获。 缺点，包括成本，负担，早期疾病的检测以及敏感性和特殊性不足 满足了对更好的监视工具的需求，我们开发了Seravue®，一种最小的侵入性，准确性， 一致且廉价的测试肝癌 - 次序蛋白抑制剂Kazal（LC-Spik），一种蛋白质 IMCARE专门由HCC细胞分泌。 Seravue®：1）它将HCC与其他肝脏肝探测，非肝病和健康受试者区分开 比α胎蛋白（AFP）更灵敏和特异性，这是最常见的生物标志物测试 HCC。 Seravue®作为II类医疗设备的清除。 LC-SPIK水平评估患有慢性肝病患者的HCC风险 引导，血液生物标志物DCP将用作主要谓词。 与DCP相比，特异性：与DCP相比，相对的HCC相对风险。 目标2。追求CMS报销并提交510（k）申请：1） CMS的报销确定了2）510（k）提交的申请：成功压缩了该estsone 预计将支持Seravue®的FDA清除率 对于HCC提供更好的功效，较低的成本和较低的当前工具。 预计Seravue®可以通过增加早期检测来挽救生命。