# Rapid point-of-care molecular test for HCV VL

> **NIH NIH R43** · REDBUD LABS, INC. · 2021 · $288,729

## Abstract

ABSTRACT
Hepatitis C, the inflammatory liver disease caused by hepatitis C virus (HCV), claims approximately 400,000
lives each year from secondary hepatocellular carcinoma and cirrhosis-induced liver failure. Direct-acting
antiviral agents can cure > 95% of the estimated 71 million cases of hepatitis C found globally, yet because of
underdiagnosis, only 7% of patients are currently receiving treatment. The diagnostic testing algorithm for HCV
necessitates multiple clinic visits. Individuals in vulnerable populations often lack the means to meet this high
follow-up burden. Increasing the prevalence of HCV treatment to reflect the 95% cure rate requires simplification
of diagnostic testing. To this end we will develop a sample-to-answer HCV viral load (VL) test that meets or
exceeds the minimal acceptable criteria as defined by the hepatitis C global stakeholder consortium.
To achieve this goal, we will combine Redbud Labs’ expertise in microfluidics and systems with the diagnostic
assay development expertise of the Diagnostics Program at PATH (Seattle, WA). In Aim 1 Redbud Labs will
optimize each assay step to the microfluidic environment using Redbud technologies and commercially
available reagents. In Aim 2 PATH will design assay primers and probes. In Aim 3 Redbud Labs will validate
the assay by performing it end-to-end using a breadboard system. Redbud technologies are production-ready,
which will minimize the risk of degradation in assay performance as we move through cartridge integration in
future Phase II work.

## Key facts

- **NIH application ID:** 10330833
- **Project number:** 1R43AI157508-01A1
- **Recipient organization:** REDBUD LABS, INC.
- **Principal Investigator:** Jay Kenneth Fisher
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $288,729
- **Award type:** 1
- **Project period:** 2021-09-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10330833

## Citation

> US National Institutes of Health, RePORTER application 10330833, Rapid point-of-care molecular test for HCV VL (1R43AI157508-01A1). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10330833. Licensed CC0.

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