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

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 SeravueTMandapos;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.ImCare Biotech has developed an ELISA test kit Seravue® for the diagnosis of liver cancer which has been demonstrated to successfully distinguish HCC from other liver diseases and non-liver diseases. In order to fully address commercialization risks, ImCare plans to refine patent, reimbursement, and licensing strategy with input from external consultants.