# Development of a urine test for the early detection of liver cancer

> **NIH NIH R44** · JBS SCIENCE, INC. · 2020 · $1,000,000

## Abstract

Development of a urine test for the early detection of liver cancer
The need to develop an effective method for detecting liver cancer is urgent. HCC, a primary liver
cancer, is the third leading cause of cancer deaths worldwide and the fastest rising cancer in US.
HCC has a 5-year survival rate of less than 15%, if detected early, the survival rate can be as high
as 40%. The survival rate drops significantly, however, to as low as 2% if the cancer has spread to
other organs. We have successfully accomplished the proposed milestones from our Phase II
award (5R44CA165312-04) to develop an HCC screening test (the JBS HCC test) that can identify
30% more HCC than serum AFP, the current most used biomarker for HCC screening. This phase
IIB application is to bridge the gap between our successful accomplishments in the Phase II period
and commercialization of the JBS HCC test for HCC screening, so more people with HCC can
benefit from early detection. The early detection of HCC is critical for the effective treatment and
cure of this disease. Although the JBS test shows great promise to improve liver cancer screening,
there are steps (identified as milestones in this application) that need to be taken before the test
can reach at-risk patients for HCC. These steps include CLIA certification (Aim 1) so that the test
can be marketed as a laboratory developed test (LDT), and filing request for a CPT code for the
third party payee reimbursement, and evaluation of performance through a multicenter, blinded
validation study to generate data supporting clinical benefit so the test can be considered as a
standard of care for HCC screening in at-risk populations (Aim 2), and standardization of urine
collection, storage, and transportation, and automation of urine cfDNA isolation to facilitate
commercialization (Aim 3). Thus, three specific Aims are proposed to prepare for the launch of the
JBS HCC screening test to the market.

## Key facts

- **NIH application ID:** 10006054
- **Project number:** 5R44CA165312-07
- **Recipient organization:** JBS SCIENCE, INC.
- **Principal Investigator:** Selena Lin
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,000,000
- **Award type:** 5
- **Project period:** 2012-07-01 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10006054

## Citation

> US National Institutes of Health, RePORTER application 10006054, Development of a urine test for the early detection of liver cancer (5R44CA165312-07). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10006054. Licensed CC0.

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