A novel multi-analyte algorithmic assay diagnostic for hepatocellular carcinoma (HCC).

Imcare Biotech, Inc., Doylestown PA

Investigators

Abstract

PROJECT SUMMARY ImCare Biotech is seeking to develop and validate Seravue AI, a novel multi-analyte algorithmic assay for early detection of hepatocellular carcinoma (HCC), the most common type of primary liver cancer. HCC is a leading cause of cancer-related deaths worldwide, with poor prognosis when detected late. Early detection significantly improves survival rates, but current surveillance methods have limitations in accuracy and accessibility, especially with imaging. Seravue AI addresses this critical need by combining ImCare Biotech's proprietary LC- SPIK biomarker with established markers AFP and DCP, integrated through an advanced AI algorithm, and only requires a simple blood sample for highly sensitive and specific HCC detection. We will collect 300 serum samples from HCC patients (early and late-stage) and at-risk controls (cirrhosis and hepatitis B patients). These samples will be tested for LC-SPIK, AFP, and DCP using ELISA assays developed by our company. After sample collection and biomarker measurements, we will develop an AI algorithm that combines the biomarker data with clinical information to detect early-stage HCC. The algorithm will be trained on a subset of the collected samples and validated on the remaining samples to ensure robustness and accuracy. Our research design involves retrospective sample collection from diverse patient populations, rigorous biomarker measurement using proprietary and standard assays, and state-of-the-art machine learning techniques. The ultimate objective is to create a highly accurate, non-invasive blood test for HCC surveillance that could potentially replace ultrasound as the standard screening method for HCC. By improving early detection rates, Seravue AI aims to enable more timely and effective treatment interventions, ultimately reducing HCC-related mortality and improving patient outcomes. Successful completion of this project will pave the way for larger clinical studies and eventual commercialization of Seravue AI as an innovative, life-saving diagnostic tool.