# Rapid, Handheld, Point-of-Care Stool Sample-prep Device for the Extraction and Detection of Nucleic Acid from Diarrheal Pathogens

> **NIH NIH R44** · GODX, INC. · 2024 · $960,626

## Abstract

Abstract
Diarrheal disease is a major health issue worldwide resulting in nearly 500,000 deaths annually
in children under 5 years of age. Those who survive have higher risk of stunted growth and
cognitive development. Identification of the gastrointestinal (GI) pathogens that cause diarrheal
disease helps guide effective treatment. Currently, in the developed world, this is done using
multiplexed PCR laboratory tests which are expensive, slow and require a sophisticated high
complexity laboratory. Unfortunately, such laboratory tests are not available in remote and
resource limited regions in the developing world where mortality due to diarrhea is the highest.
Thus, we propose to develop an integrated, low-cost, point-of-care (POC) test to identify the GI
pathogens that cause diarrheal diseases. This test will be useful in resource-limited settings of
the developing world as well as in primary care and urgent care settings of the developed world
where it will be useful to detect the GI pathogens in real time, in the clinician's office so the
patient can be treated with the right drugs, right away, without loss of patients to follow up. The
major problem with detecting gastrointestinal (GI) pathogens is the complexity of stool samples,
often filled with particulate and molecules such as bile salts. Such contaminants can inhibit
signal amplification and detection if not properly removed from the sample. In previous SBIR
projects, GoDx has developed sample preparation chemistry, DNA amplification and detection
assays on lateral flow paper strips for a suite of GI pathogens. Our next step is to develop a
pathogen detection device that fully integrates sample processing and signal amplification,
which can be used rapidly at the point of care (POC). To achieve this, we propose to develop a
stool sample prep device that can robustly provide viable DNA for amplification and detection all
while requiring minimal user action to do so. The technology proposed here will be able to
extract and enrich DNA from a swab of stool in a matter of minutes without the need for
centrifuges or pumps. In Phase 2 of this project, we will fully integrate the GoDx’s amplification
and detection assays with the sample prep technology developed here, providing a seamless,
minimal step POC device for the detection of GI pathogens that cause diarrheal diseases
around the world.

## Key facts

- **NIH application ID:** 10850789
- **Project number:** 5R44AI155367-03
- **Recipient organization:** GODX, INC.
- **Principal Investigator:** Chang Hee Kim
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $960,626
- **Award type:** 5
- **Project period:** 2020-06-01 → 2025-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10850789

## Citation

> US National Institutes of Health, RePORTER application 10850789, Rapid, Handheld, Point-of-Care Stool Sample-prep Device for the Extraction and Detection of Nucleic Acid from Diarrheal Pathogens (5R44AI155367-03). Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/grant/nih/10850789. Licensed CC0.

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