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

摘要 ImCare Biotech开发了一种高精度和特异性的基于ELISA的肝细胞诊断方法 癌症。商标为SeravueTM，该测试对LC-Spik进行量化，LC-Spik是一种仅在病例中分泌的新蛋白质 得了肝癌。我们的I期和II期临床研究已经验证了SeravueTM区分肝癌的能力。 患有肝硬变、乙肝/丙型肝炎、胰腺炎等非肝脏疾病的患者，以及 健康受试者。在512例患者中，LC-SPIK的敏感性为80%，特异性为90%。 对FDA批准的广泛使用的生物标志物甲胎蛋白(AFP)的敏感性和特异性分别为52%和86% 肝细胞癌的。更令人印象深刻的是，SeravueTM能够在其最早的阶段(BCLC阶段0和1)发现肝癌， 检测对患者预后和5年生存率影响最大的地方，灵敏度为72% 90%的特异性。这与AFP相比非常有利，只有42%的敏感性和86%的特异性。 最后，SeravueTM能够给出超过71%的AFP检测为假阳性的患者的真阳性结果- 阴性结果，为AFP检测遗憾为阴性的大约47%的肝癌患者提供了解决方案。 通过我们的第一阶段和第二阶段SBIR资助的开发，我们已经完成了 我们的诊断产品。我们还通过正式的提交前会议与FDA会面，以确定 FDA批准的要求，并正在与几家领先的诊断公司进行商业许可讨论 包括Fujirebio、Diasorin和BioRad在内的公司。然而，虽然我们的技术和现有的IP提供了 在拥有强大基础的美国，有几个关键领域的额外支持对商业成功至关重要。 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 专利版图和围绕表位声明的战略，以实现更全面的国际覆盖。 这将使我们能够尽可能有效地对特定专利、权利要求和国际地区进行优先排序。 其次，我们必须进一步制定我们的报销战略，包括与CMS进行额外的讨论， 这是潜在的商业合作伙伴明确要求我们做的。最后，我们希望与 在组织和执行诊断许可交易方面具有丰富经验的许可顾问。这是一个 我们商业化计划中的关键一步，与这样的合作伙伴合作将大大加强 这是我们经验较少的关键领域。CRP拨款将使我们能够解决这些剩余的问题 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，我们非常感谢这些年，这将是全世界最有机会 商业上的成功。

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.