# Point-of-care HIV viral load system using RPA and MXR

> **NIH NIH R44** · REDBUD LABS, INC. · 2022 · $952,622

## Abstract

ABSTRACT
The most accurate way to monitor the efficacy of antiretroviral therapy is through nucleic acid
amplification tests (NAATs) that directly measure HIV RNA (viral load). In the developing and
developed world these tests are primarily conducted in centralized laboratories in urban centers.
However, a significant number of persons living with HIV reside in rural locations, and due
tolack of transportation, financial constraints, or a combination of these factors, would be better
served by a test closer to the point-of-care (POC). Despite advancements in portable nucleic
acid amplification technology there remains significant opportunity to improve affordability, time-
to-result, and ease-of-use of POC HIV viral load (VL) testing. To this end we will complete
development of our rapid, sample-to-answer HIV VL test that achieves better metrics in these
areas than today’s commercial platforms.
In this Phase II project, we will continue our collaboration with the Diagnostics Program at PATH
(Seattle, WA) to finalize and test the completed device. In Aim 1 Redbud Labs will finalize and
integrate the test cartridge and device into a compact, robust instrument. In Aim 2 Redbud Labs
will verify quantitation and genomic coverage of the automated assay. In Aim 3 PATH will
perform analytic validation of the system using clinical samples, comparing those results against
a gold standard. At this project’s completion we will have a platform ready for multi-site clinical
validation.

## Key facts

- **NIH application ID:** 10484628
- **Project number:** 9R44MH132130-02A1
- **Recipient organization:** REDBUD LABS, INC.
- **Principal Investigator:** Jay Kenneth Fisher
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $952,622
- **Award type:** 9
- **Project period:** 2019-08-01 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10484628

## Citation

> US National Institutes of Health, RePORTER application 10484628, Point-of-care HIV viral load system using RPA and MXR (9R44MH132130-02A1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10484628. Licensed CC0.

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