# A Lateral Flow Assay for Rapid Saliva Fentanyl Detection (sFENTANYL)

> **NIH NIH R43** · INSTANOSIS, INC. · 2022 · $256,554

## Abstract

Project Summary
Fentanyl is a major contributor to the Opioid Epidemic. Rapid identification of the causative drug
as fentanyl is critical for prompt and appropriate administration of naloxone, and the right level of
clinical care. From the public health perspective, rapid identification of fentanyl is also key to
overdose surveillance, outbreak recognition and communication among healthcare professionals.
The global market for point-of-care (POC) drug of abuse testing, fueled by the continued growth
of illicit drug use worldwide, especially fentanyl and its derivatives, is estimated to be $3.8 billion
in 2023, growing at a compound annual growth rate (CAGR) of 5.4%. Oral fluid drugs of abuse
testing market is estimated at $38.8 million in 2023. However, there is currently no FDA-approved
or cleared rapid diagnostic for fentanyl screening at the POC. In this phase I STTR proposal,
Instanosis Inc will partner with University of Pennsylvania to develop and commercialize a rapid
onsite screening diagnostics (sFENTANYL) that can be deployed at the patient’s side to quickly
identify fentanyl in saliva. In sFENTANYL, saliva is collected using swabs, quickly extracted and
applied to the saliva lateral flow assay (sFENTANYL) strip that can effectively detect 0.1 ng/mL
fentanyl in saliva within 5 min. Readout is visual with naked eyes, with no need for external
instruments. This rapid diagnostic tool meets the clinical needs of fentanyl detection at the POC:
rapid, sensitive, portable and low cost, and can be used in many settings, including first response
vehicles, emergency departments, detoxification clinics, drug treatment clinics and patient homes.
In Phase I, we will develop sFENTANYL with the needed analytical sensitivity and readout time,
and conduct preliminary validation using deidentified clinical saliva samples.

## Key facts

- **NIH application ID:** 10388804
- **Project number:** 1R43DA055415-01
- **Recipient organization:** INSTANOSIS, INC.
- **Principal Investigator:** Md Mezbah Uddin
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $256,554
- **Award type:** 1
- **Project period:** 2022-09-01 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10388804

## Citation

> US National Institutes of Health, RePORTER application 10388804, A Lateral Flow Assay for Rapid Saliva Fentanyl Detection (sFENTANYL) (1R43DA055415-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10388804. Licensed CC0.

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