A novel diagnostic Kit for Hepatocellular Carcinoma

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 rt70%. 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.