# Sensitive and Portable Physician Office-Based Urine Analyzer to Tackle Prescription Drug Abuse

> **NIH NIH R44** · BREVITEST TECHNOLOGIES, INC. · 2020 · $511,333

## Abstract

PROJECT SUMMARY
BreviTest Technologies, LLC, proposes to develop a low-cost, point-of-care (POC) urine drug testing
(UDT) device to detect opioids. The goal is for the assay platform to deliver quantitative performance
similar to a standard laboratory ELISA. Phase I research and development showed the repeatability
and accuracy of BreviTest’s proprietary assay technology. Current drug-screening immunoassays
use benchtop analyzers that require experienced personnel, time, and a laboratory setup. Physicians
without access to in-house testing have to send out patient samples for screening, resulting in
unacceptable delays in the treatment of patients who are potentially suffering from chronic pain. Thus
most physicians do not follow the federal recommendations to use urine drug testing (UDT) before
prescribing opioids to identify potential opioid abuse, either from overdosing (above expected levels
of opioids in urine) or intent to resell (low or absent opioids despite patient claims to the contrary).
BreviTest Technologies has developed a low-cost, layman operable, POC analyzer to perform a
quantitative ELISA test within a 10-minute run time. The sample is loaded into a cartridge that is
placed in the analyzer and an automated mechanism controls the movement of antibody-conjugated
magnetic microparticles through successive fluid wells with enhanced mixing patterns. This innovative
approach enables the implementation of a rapid, portable, fully automated ELISA test with accuracy
comparable to a standard laboratory ELISA. The Specific Aims for this Phase II project are: (1)
Finalize development and implementation of repeatability and calibration protocols according to
industry standards for the diagnostic device and disposable test cartridges; (2) Build and characterize
fully integrated prototypes to obtain a finalized device design, packaging, process, and tooling; (3)
Perform testing of finalized BreviTest device and performance validation using patient urine samples.
The expected outcome of this project will be a device designed for manufacturing (DFM), built and
characterized by a contract manufacturer, validated in a pilot study and user simulation, ready to
enter design controls, and with a regulatory and commercialization path in place. BreviTest offers a
unique platform to create an ELISA test for performing rapid quantifications of urine drug levels in a
physician’s office, providing an invaluable tool to render more effective pain management dosing to
patients, thus paving the way towards lower toxicity and a better quality of life.

## Key facts

- **NIH application ID:** 9884752
- **Project number:** 5R44DA043325-03
- **Recipient organization:** BREVITEST TECHNOLOGIES, INC.
- **Principal Investigator:** MICHAEL JOHN HEFFERNAN
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $511,333
- **Award type:** 5
- **Project period:** 2017-03-01 → 2020-12-21

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9884752

## Citation

> US National Institutes of Health, RePORTER application 9884752, Sensitive and Portable Physician Office-Based Urine Analyzer to Tackle Prescription Drug Abuse (5R44DA043325-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9884752. Licensed CC0.

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