Comprehensive Intellectual Property, Reimbursement, and Licensing Strategy for ImCare Biotech's Diagnostic Product Seravue

ImCare Biotech 诊断产品 Seravue 的全面知识产权、报销和许可策略

• 批准号: 10154439
• 负责人: Xuanyong Lu
• 金额: $ 16.67万
• 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 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10154439
• 关键词: Address; Agreement; Antibodies; Area; Binding; Biological Markers; Biotechnology; Clinical Research; Detection; Development; Devices; Diagnosis; Diagnostic; Diagnostic Reagent Kits; Early Diagnosis; Ensure; Enzyme-Linked Immunosorbent Assay; Epitopes; Evaluation; FDA approved; Foundations; Freedom; Funding; Grant; Hepatitis; Hepatitis B; Hepatocyte; Intellectual Property; International; Laws; Lawyers; Legal patent; Licensing; Litigation; Liver Cirrhosis; Liver diseases; Malignant neoplasm of liver; Mediation; Medicare; Methods; Monoclonal Antibodies; Pancreatitis; Pathway interactions; Patient-Focused Outcomes; Patients; Performance; Phase; Positioning Attribute; Primary carcinoma of the liver cells; Privatization; Process; Proteins; Resources; Risk; Secure; Sensitivity and Specificity; Serine Proteinase Inhibitors; Serum; Small Business Innovation Research Grant; Solid; Specificity; Structure; Survival Rate; Technology; Testing; TimeLine; Trademark; United States National Institutes of Health; Work; alpha-Fetoproteins; base; commercialization; diagnostic assay; effectiveness evaluation; experience; invention; meetings; novel; outreach; phase 2 study; prevent; success; tool

Abstract ImCare Biotech has developed a highly accurate and specific ELISA based diagnostic assay for hepatocellular carcinoma. Trademark pending as SeravueTM, the test quantifies LC-SPIK, a novel protein secreted only in cases of liver cancer. Our Phase I and Phase II clinical studies have validated SeravueTM's ability to distinguish HCC in patients from those who have liver cirrhosis, Hepatitis B/C, non-liver diseases such as pancreatitis, as well as healthy control subjects. In 512 total patients, LC-SPIK had a sensitivity of 80% and specificity of 90%, compared to only 52% sensitivity and 86% specificity for Alpha fetoprotein (AFP), a widely used FDA-approved biomarker for HCC. More impressively, SeravueTM was able to detect HCC in its earliest stages (BCLC Stage 0 and 1), where detection makes the biggest difference in patient outcomes and 5-year survival rate, with 72% sensitivity and 90% specificity. This compared very favorably to AFP, with only 42% sensitivity and 86% specificity. Finally, SeravueTM was able to give a true-positive result in over 71% of patients where AFP testing gave a false- negative result, offering a solution for the roughly 47% of HCC patients who regrettably test negative with AFP. Through our phase I and phase II SBIR funded development, we have completed the technical development of our diagnostic product. We have also met with the FDA through a formal pre-submission meeting to establish requirements for FDA approval and are amidst commercial license discussions with several leading diagnostic companies including FujireBio, Diasorin, and BioRad. However, while our technology and existing IP provide us with a strong foundation, there are several key areas where additional support is critical to commercial success. First, while our existing patents offer provide some direct protection, we need to further analyze the relevant patent landscape and strategize around epitope claims to enable more comprehensive coverage internationally. This will allow us to prioritize specific patents, claims, and international regions as effectively as possible. Second, we must further develop our reimbursement strategy, including additional discussion with CMS, which is something that potential commercial partners have explicitly asked us for. Lastly, we would like to work with a licensing advisor with significant experience in structuring and executing diagnostic licensing deals. This is a critical step in our commercialization plan and collaborating with such a partner would significantly strengthen this key area where we are less experienced. A CRP grant would allow us to address these remaining commercialization risks and ensure that the technical and scientific breakthroughs we have achieved in the last 6 years with the support of the NIH/NCI, for which we are very thankful, will have the best chance of worldwide commercial success.

摘要 ImCare Biotech开发了一种高度准确和特异性的基于ELISA的肝细胞诊断方法， carcinoma.正在申请商标SeravueTM，该测试定量LC-SPIK，一种仅在病例中分泌的新型蛋白质， 肝癌我们的I期和II期临床研究已经验证了SeravueTM区分HCC的能力， 患有肝硬化、B/C型肝炎、胰腺炎等非肝脏疾病以及 健康对照组。在512例患者中，LC-SPIK的敏感性为80%，特异性为90%， 甲胎蛋白（AFP）的敏感性仅为52%，特异性为86%， 对于HCC。更令人印象深刻的是，SeravueTM能够在其最早期（BCLC 0期和1期）检测HCC， 其中检测对患者结局和5年生存率的影响最大，灵敏度为72% 和90%的特异性。这与AFP相比非常有利，只有42%的灵敏度和86%的特异性。 最后，SeravueTM能够在超过71%的AFP检测为假阳性的患者中给出真阳性结果， 阴性结果，为大约47%的肝癌患者提供了一个解决方案，这些患者遗憾地用AFP检测为阴性。 通过我们的第一阶段和第二阶段SBIR资助的发展，我们已经完成了技术开发， 我们的诊断产品我们还通过正式的提交前会议与FDA会面， FDA批准的要求，并正在与几家领先的诊断公司讨论商业许可证。 公司包括FujireBio、Diasorin和BioRad。然而，尽管我们的技术和现有的知识产权提供了 我们有一个坚实的基础，有几个关键领域，额外的支持是至关重要的商业成功。 首先，虽然我们现有的专利提供了一些直接的保护，但我们需要进一步分析相关的 专利格局和围绕表位权利要求制定战略，以实现更全面的国际覆盖。 这将使我们能够尽可能有效地优先考虑特定的专利、权利要求和国际地区。 第二，我们必须进一步制定我们的报销策略，包括与CMS进行更多的讨论， 是潜在的商业合作伙伴明确要求我们的。最后，我们希望与 在构建和执行诊断许可交易方面具有丰富经验的许可顾问。这是一 这是我们商业化计划的关键一步，与这样的合作伙伴合作将大大加强我们的商业化计划。 我们在这一关键领域经验不足。CRP赠款将使我们能够解决这些剩余的 商业化风险，并确保我们在过去6年中取得的技术和科学突破 在NIH/NCI的支持下，我们非常感谢，这将是世界范围内最好的机会。 商业成功。