# A novel diagnostic Kit for Hepatocellular Carcinoma

> **NIH NIH R44** · IMCARE BIOTECH, INC. · 2021 · $1,420,847

## Abstract

PROJECT SUMMARY
ImCare Biotech is seeking to commercialize Seravue®, an ELISA-based diagnostic system that is able to
identify both early and late stage Hepatocellular Carcinoma (HCC) with high sensitivity and specificity. With NCI-
supported Phase I and II SBIR awards plus internal and external investor support, ImCare completed the
technical development of the Seravue® product and now requests Phase IIB SBIR support to conduct a
prospective clinical study required for a 510(k) filing and subsequent regulatory clearance. Commercialization
of Seravue® has the potential to substantially improve early detection of HCC in patients undergoing
surveillance due to high-risk conditions, thereby ensuring timely, effective treatment and greatly
increasing survival. HCC, the most common and deadliest form of liver cancer, has a 5-year survival rate of
less than 15% and is directly responsible for hundreds of thousands of deaths worldwide each year. HCC is
typically diagnosed at a late stage when treatments are largely ineffective, resulting in poorer prognosis, but
early diagnosis and treatment can increase 5-year survival rates to >70%. Thus, individuals known to be at high
risk for HCC—including patients with liver cirrhosis or chronic hepatitis B/C—undergo HCC surveillance every 3
to 6 months to improve the chances of catching the disease early. Current surveillance methods have significant
drawbacks including cost, burden, poor detection of early disease, and inadequate sensitivity and specificity. To
address the need for a better surveillance tool, we developed Seravue®, a minimally-invasive, accurate,
consistent, and inexpensive test for Liver Cancer-Serine Protease Inhibitor Kazal (LC-SPIK), a protein
specifically secreted by HCC cells. In Phase I and Phase II studies, ImCare confirmed two critical features of
Seravue®: 1) It distinguishes HCC from other liver diseases, non-liver diseases, and healthy subjects and 2) it
is significantly more sensitive and specific than alpha fetoprotein (AFP), the most common biomarker test for
HCC. In this Phase IIB SBIR, ImCare proposes to conduct a clinical study to support a 510(k) filing for the
clearance of Seravue® as class II medical device. Aim 1. Demonstrate the feasibility and effectiveness of using
serum levels of LC-SPIK to assess the risk of developing HCC for patients with chronic liver disease. Per FDA
guidance, the blood biomarker DCP will be used as the primary predicate. Primary Endpoints: Sensitivity and
specificity compared to DCP. Secondary Endpoint: Calculated relative risk of developing HCC compared to DCP.
Aim 2. Pursue CMS reimbursement and submit a 510(k) application. Milestones: 1) Additional requirements for
CMS reimbursement identified and 2) 510(k) filing submitted. Impact: Successful completion of these milestones
is expected to support FDA clearance of Seravue®, which will provide an early detection and surveillance tool
for HCC that provides better efficacy, lower cost, and lower bu...

## Key facts

- **NIH application ID:** 10249530
- **Project number:** 2R44CA165314-05A1
- **Recipient organization:** IMCARE BIOTECH, INC.
- **Principal Investigator:** Xuanyong Lu
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,420,847
- **Award type:** 2
- **Project period:** 2012-09-01 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10249530

## Citation

> US National Institutes of Health, RePORTER application 10249530, A novel diagnostic Kit for Hepatocellular Carcinoma (2R44CA165314-05A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10249530. Licensed CC0.

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