# AcetaSTAT Validation and Commercialization

> **NIH NIH SB1** · ACETAMINOPHEN TOXICITY DIAGNOSTICS, LLC · 2023 · $1,068,321

## Abstract

James, Laura P
Project Summary/Abstract
Acetaminophen (APAP) is the most common drug used for the treatment of pain and fever around
the world. It is also the most common cause of life threatening drug-induced liver damage.
Unfortunately, physicians have no specific test available to them to confirm the diagnosis of APAP
liver injury. Currently, physicians rely on patient history and non-specific tests of liver injury when
evaluating patients with liver injury due to APAP. Acetaminophen Toxicity Diagnostics, LLC has
developed a rapid lateral flow immunoassay that can detect APAP liver injury. Our test, known as
AcetaSTAT, is fast, easy and specific to APAP liver injury. Our plans for this commercialization
readiness program proposal include optimizing AcetaSTAT in a collaboration with DCN
Diagnostics. Secondly, we will produce AcetaSTAT according to current Good Manufacturing
Practice (cGMP). Finally, we will complete in vitro validation studies and perform a multi-site
clinical trial to examine the clinical performance of AcetaSTAT. These efforts will support the
submission of a de novo application to the Food and Drug Administration for clearance for sales
of AcetaSTAT in the US. Ultimately, AcetaSTAT will expedite and simplify the diagnosis of APAP
liver injury, prompting more rapid treatment, and saving lives.
OMB No. 0925-0001/0002 (Rev. 03/2020 Approved Through 02/28/2023) Page 1

## Key facts

- **NIH application ID:** 10598625
- **Project number:** 5SB1DK079387-10
- **Recipient organization:** ACETAMINOPHEN TOXICITY DIAGNOSTICS, LLC
- **Principal Investigator:** Laura P James
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $1,068,321
- **Award type:** 5
- **Project period:** 2008-04-01 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10598625

## Citation

> US National Institutes of Health, RePORTER application 10598625, AcetaSTAT Validation and Commercialization (5SB1DK079387-10). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10598625. Licensed CC0.

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