# Translation of a biomarker panel for the early detection of hepatocellular carcinoma

> **NIH NIH R01** · MEDICAL UNIVERSITY OF SOUTH CAROLINA · 2022 · $521,077

## Abstract

This application proposes to translate our identification of a biomarker panel for hepatocellular carcinoma to
commercial and clinical use. We have identified a specific post-translation modification that is altered in HCC.
This alteration is a shift in the composition of N-linked glycans found on proteins made in and secreted by HCC
cells. Many of the proteins containing this glycan alteration have been identified and patented. Our strong
preliminary evidence has shown that some of these proteins, when combined with existing biomarkers and
clinical factors, have excellent discriminatory ability between those with HCC and those with cirrhosis.
Importantly, our biomarker efforts have focused on the detection of early stage lesions using our current
biomarker panel, which is a simple logistic regression algorithm composed of fucosylated kininogen, alpha-
fetoprotein (AFP), alkaline phosphatase (ALK), aspartate aminotransferase (AST), age and gender. Called the
kininogen panel, it had an area under the receiver operator curve (AUROC) of 0.97 for the differentiation of early
stage HCC from cirrhosis. In an independent external validation of this panel, in three independent cohorts this
panel had an AUROC of 0.92 to 0.97 in the detection of early stage HCC. Thus our enthusiasm for this biomarker
panel is high. To fully understand the clinical and commercial benefits of any biomarker, a large scale clinical
validation study that is appropriate powered is essential. Hence, the two goals of this application are to validate
the kininogen panel for the detection of early stage HCC at the time of HCC diagnosis (Aim 1) and determine
when in time an individual becomes biomarker positive prior to developing HCC (Aim 2). At the completion of
these two aims, Glycotest will have validated this biomarker panel and have confidence in its performance.
Glycotest's strategy is focused on commercialization of its tests as Laboratory Developed Test (LDT) service
products. These tests will be marketed to and ordered by specialists who care for the patient populations at risk
for liver cancers and fibrosis-cirrhosis. LDTs are tests developed and run in a single "CLIA lab" regulated by the
Center for Medicare & Medicaid Services (CMS) through the Clinical Laboratory Improvement Amendments
(CLIA). The LDT business model has been used successfully by many other US companies that have
commercialized tests as service products in multiple disease areas. The Company will establish an internal
selling and marketing capability focused initially on major influential medical centers and key opinion leader sites
as well as the west coast and east coast geographical areas, and will pursue a strategy for establishing Medicare
reimbursement that it has developed in collaboration with external experts.

## Key facts

- **NIH application ID:** 10478012
- **Project number:** 5R01CA237659-04
- **Recipient organization:** MEDICAL UNIVERSITY OF SOUTH CAROLINA
- **Principal Investigator:** JORGE A MARRERO
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $521,077
- **Award type:** 5
- **Project period:** 2019-09-18 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10478012

## Citation

> US National Institutes of Health, RePORTER application 10478012, Translation of a biomarker panel for the early detection of hepatocellular carcinoma (5R01CA237659-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10478012. Licensed CC0.

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