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

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.

Grant Number: 1R43CA302053-01
NIH Institute/Center: NIH
Principal Investigator: Bobby Biswal