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

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44DA043325-02
Agency Tracking Number: R44DA043325
Amount: $1,497,460.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIDA
Solicitation Number: PA18-574
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-04-01
Award End Date (Contract End Date): 2021-09-30
Small Business Information
3900 ESSEX LN STE 575
Houston, TX 77027-5175
United States
DUNS: 079204766
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 MICHAEL HEFFERNAN
 (281) 615-4704
 michael@fannininnovation.com
Business Contact
 DEV CHATTERJEE
Phone: (713) 341-1188
Email: brevitest-so@brevitest.com
Research Institution
N/A
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.PROJECT NARRATIVE. Deaths from prescription opioids account for nearly one-fifth of all drug-related deaths
in the US (134 deaths daily), through overdosing and misuse. Federal health agencies, aware of this growing
epidemic, have advocated urinary drug testing prior to prescriptions; however, physician compliance is poor
because of the additional wait period for laboratory results. The proposed point-of-care diagnostic device will fill
a critical unmet need for an affordable and quick urinary opioid test that can be used by physicians in their offices
for objective, accurate assessments prior to prescribing opioids. The technology can potentially be used in pain
clinics, private practice, public health laboratories, and urban emergency departments throughout the United
States.

* Information listed above is at the time of submission. *

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