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

> **NIH NIH R44** · REDBUD LABS, INC. · 2024 · $999,310

## Abstract

ABSTRACT
Chronic hepatitis C virus (HCV) infection is a hidden public health problem, due to ineffective
disease testing and surveillance strategies. Testing for HCV is two-step, with patients initially
screened for HCV antibodies, followed with an RNA viral load (VL) test at a subsequent visit.
However, follow up rates are low due to the time it takes to obtain results and the need for multiple
visits for treatment. Point of care (POC) testing is vital for disease surveillance of chronic infections
like HCV, as these tests can be performed in a single visit and decrease treatment initiation time.
Current HCV POC VL testing platforms do not meet the global stakeholder-generated target
product profile to identify active HCV infection. An additional barrier to HCV testing is sample
preparation, which is laborious, time consuming, prone to human error, and expensive. Thus, we
believe the correct strategy for HCV POC VL testing is a low-cost, automated platform that
performs HCV isolation utilizing gold-standard magnetic bead-based protocols, for shorter time to
results, greater sensitivity, and a lower limit of detection. This strategy will allow for more
widespread and accurate HCV community testing and surveillance, reducing hands-on time and
operator burden, as well as the global healthcare burden of HCV infection.
This Phase II project will implement sample-to-answer HCV POC VL testing by building on our
automated sample preparation platform and successful Phase I development of an RPA
isothermal assay for HCV detection.

## Key facts

- **NIH application ID:** 10932002
- **Project number:** 2R44AI157508-02
- **Recipient organization:** REDBUD LABS, INC.
- **Principal Investigator:** Jay Kenneth Fisher
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $999,310
- **Award type:** 2
- **Project period:** 2021-09-01 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10932002

## Citation

> US National Institutes of Health, RePORTER application 10932002, Rapid point-of-care molecular test for HCV VL (2R44AI157508-02). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10932002. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*