# Rapid, Point-of-Care Nucleic Acid Test for HCV

> **NIH NIH R44** · CROSSLIFE TECHNOLOGIES, INC. · 2020 · $990,440

## Abstract

Rapid, Point-of-Care Nucleic Acid Test for HCV
CrossLife Technologies Inc.
Project Summary/Abstract
Approximately 500 000 people die each year from hepatitis C-related liver diseases [1].
The hepatitis C virus can cause both acute and chronic hepatitis infection [1-2]. Over time,
chronic Hepatitis C can cause serious health problems including liver damage, liver failure,
and even liver cancer. Early detection can save lives. If the antibody test is reactive, an
additional nucleic acids based (RNA) test is needed to determine if a person is currently
infected with Hepatitis C. If the RNA test is positive, this means a person currently has
Hepatitis C and should talk to a doctor and treating the disease.
There is an urgent need for sensitive and specific point-of-care (POC) diagnostics for
HCV. Nucleic-acid based POC tests have the potential to offer timely, sensitive and
accurate diagnosis of HCV for imparting proper care and treatment – especially in settings
without robust clinical laboratory support. The availability of a POC assay to distinguish
which HCV seropositive patients are infected and ascertain whether patients have
developed a sustained virologic response (SVR) will make it possible to treat patients on
a global basis in the current era of highly effective pan-genotypic HCV regimens.
Therefore, we aim to develop a rapid, multiplex test that detects and genotypes all
six genotypes of HCV at the point-of-need in < 30 minutes and is appropriate for
non-laboratory settings and non-technical personnel. Our proprietary test exploits a
novel probe reaction chemistry that allows multiplexed detection of DNA or RNA without
sample purification, making it operable as a simple, hand-held test. Patient samples to be
input directly into the device without pre-processing and a disposable cartridge carry out
amplification of all targets and reports visible results that can be read by eye. We expect
a sensitivity (>90%) and specificity (>90%) to the qRT-PCR data on the same samples.
We will also conduct a large-scale validation and obtain World Health Organization (WHO)
expedited review approval and recommendation for procurement on our product and
market it first to non-governmental organizations (NGO) such as the Doctors Without
Borders or the Gates Foundation. We will obtain USFDA 510 K clearance in Phase 3 in
order to market our product in the U.S.

## Key facts

- **NIH application ID:** 10017197
- **Project number:** 5R44DK123849-02
- **Recipient organization:** CROSSLIFE TECHNOLOGIES, INC.
- **Principal Investigator:** HyunDae Cho
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $990,440
- **Award type:** 5
- **Project period:** 2019-09-15 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10017197

## Citation

> US National Institutes of Health, RePORTER application 10017197, Rapid, Point-of-Care Nucleic Acid Test for HCV (5R44DK123849-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10017197. Licensed CC0.

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