# Rapid, Instrument-free and High Sensitivity Over-the-counter Urine Fentanyl Testing

> **NIH NIH R44** · INSTANOSIS, INC. · 2024 · $403,636

## Abstract

Project Summary
 Fentanyl is the leading cause of overdose deaths in the United States. The majority of
fentanyl-related overdoses are caused by illicit fentanyl and/or fentanyl analogs, either alone or
in combination with other narcotics. Rapid identification of fentanyl as the contributing drug is
crucial for clinical management of overdose patients, who may undergo respiratory depression in
minutes. Even in the case of adulteration of fentanyl with any other opioid, the detection of fentanyl
is important for the appropriate dosage and frequency of naloxone. Despite the clinical and public
health needs, there is currently no rapid and instrument-free fentanyl detecting diagnostic cleared
by FDA. Central clinical laboratory screening tests rely on expensive instrumentation and report
results hours after urine sample is submitted for testing. Mass spectrometry-based methods for
fentanyl are only available from selected hospital labs as lab-developed tests, and report results
days after sample is collected. Neither existing method is useful for immediate clinical
management, nor widely accessible to the populations who are most affected by fentanyl and
emerging drug threats. Current commercially available fentanyl strips do not have the sensitivity
to meet the clinically meaningful 1 ng/mL cutoff required by FDA. Instanosis has developed a
rapid screening strip called InstaStrip-Fentanyl that uniquely meets the 1 ng/mL cutoff requirement.
The entire test is completed in 3 simple steps within minutes. After urine collection, the user
transfers urine to a reagent tube, mixes, then places the strip into the tube. Visual results can be
read in 5 min. We have reached agreement with FDA in a presubmission meeting on proposed
510(k) regulatory pathway and studies required for clearance. In this fast-track proposal,
Instanosis proposes to finalize the development and commercialize InstaStrip-Fentanyl as the
first 510(k)-cleared, rapid, instrument-free and high sensitivity over-the-counter (OTC) fentanyl
screening test. In Phase I, Instanosis will work on finalizing the test design with cutoff of 1 ng/mL
under Quality Management System (QMS) and conduct clinical validation. In Phase II, Instanosis
will partner with an FDA-registered contract manufacturer to manufacture three different test lots,
conduct verification and validation studies, including analytical, accuracy flex and method
comparison studies. We will also enroll users in an OTC usability study to evaluate and document
the usability of the device. These studies will generate data for 510(k) submission. After
completion of the fast-track project, the immediate next step is the submission of 510(k)
application to FDA for OTC clearance, to allow marketing and distribution in both the professional
healthcare and consumer markets. Although the project focuses on fentanyl, the infrastructure,
resources and workflow built during this project will serve as a blueprint for Instanosis to rapidly
adapt to...

## Key facts

- **NIH application ID:** 10907992
- **Project number:** 1R44DA060647-01
- **Recipient organization:** INSTANOSIS, INC.
- **Principal Investigator:** Ping Wang
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $403,636
- **Award type:** 1
- **Project period:** 2024-04-01 → 2025-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10907992

## Citation

> US National Institutes of Health, RePORTER application 10907992, Rapid, Instrument-free and High Sensitivity Over-the-counter Urine Fentanyl Testing (1R44DA060647-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10907992. Licensed CC0.

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