SBIR-STTR Award

Saliva Analyzer for Diagnosing SRD Patient Drug Use
Award last edited on: 1/28/16

Sponsored Program
SBIR
Awarding Agency
NIH : NIDA
Total Award Amount
$1,190,673
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Stuart Farquharson

Company Information

Real-Time Analyzers Inc

362 Industrial Park Road Unit 8
Middletown, CT 06457
   (860) 635-9800
   info@rta.biz
   www.rta.biz
Location: Single
Congr. District: 03
County: Middlesex

Phase I

Contract Number: 1R43DA032178-01
Start Date: 7/15/12    Completed: 12/31/12
Phase I year
2012
Phase I Amount
$156,535
The overall aim of this SBIR program is to develop a surface-enhanced Raman spectroscopy (SERS) based device for on-site analysis of drugs in saliva. This device will allow immediate assessment of both medicinal and illicit drug use by patients with substance-related disorders (SRDs), and provide medical professionals and management with quantitative data so that treatment decisions can be made. Successful treatments for SRD patients require frequent monitoring of both medicinal and illicit drug use, which are mostly done in outpatient settings (doctor's office, rehabilitation centers, etc.) employing urine- based drug tests. For such tests, a sample is screened with immunoassay test kits, and if a drug is present, it is confirmed and quantified by gas chromatography - mass spectrometry (GC-MS). Unfortunately, immunoassay test kits are susceptible to false positives, while the GC-MS method is time consuming and requires highly trained operators and a laboratory setting. Consequently, there is a critical need for a device that combines the portability, speed and ease-of-use of immunoassay kits with the identification and quantitation abilities of GC-MS so that health care personnel can assess SRD patient compliance in outpatient settings. The proposed SERS Saliva Analyzer (SSA) will meet all such requirements by providing health care personnel an easy-to-use device, which will extract, identify and quantify the presence of drugs (and metabolites) at requisite levels in saliva (1-50 ng/mL), within 10 minutes. The overall aim of the Phase I program is to demonstrate feasibility by detecting two priority drugs (cocaine and diazepam) in saliva at physiologically relevant concentrations and analysis time. This will be accomplished by 1) measuring cocaine and diazepam at required sensitivity, and 2) measuring cocaine and diazepam in saliva.

Public Health Relevance:
The overall aim of this SBIR program is to develop a surface-enhanced Raman spectroscopy (SERS) based device for on-site analysis of drugs in saliva. This device will allow immediate assessment of both medicinal and illicit drug use by patients with substance-related disorders (SRDs), and provide medical professionals and management with quantitative data so that treatment decisions can be made.

Public Health Relevance Statement:
The overall aim of this SBIR program is to develop a surface-enhanced Raman spectroscopy (SERS) based device for on-site analysis of drugs in saliva. This device will allow immediate assessment of both medicinal and illicit drug use by patients with substance-related disorders (SRDs), and provide medical professionals and management with quantitative data so that treatment decisions can be made.

NIH Spending Category:
Drug Abuse (NIDA only); Substance Abuse

Project Terms:
base; Calibration; Chemistry; Clinical; Cocaine; Compliance behavior; Data; Detection; Devices; Diagnosis; Diazepam; Drug Monitoring; drug testing; Drug usage; Gel; Gold; Health Personnel; Illicit Drugs; Immunoassay; improved; Laboratories; Mass Fragmentography; Measurement; Measures; Medical; meetings; Metals; Methods; Monitor; Outpatients; Patients; Performance; Pharmaceutical Preparations; Phase; portability; programs; Raman Spectrum Analysis; Reagent; Rehabilitation Centers; Reporting; Reproducibility; Research; response; ROC Curve; Saliva; Sampling; Schedule; Silver; Site; Small Business Innovation Research Grant; Speed (motion); Substance-Related Disorders; Surface; Testing; Time; Training; Urine; Water

Phase II

Contract Number: 2R44DA032178-02
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
2014
(last award dollars: 2015)
Phase II Amount
$1,034,138

The overall aim of this SBIR program is to develop a surface-enhanced Raman spectroscopy (SERS) based device for point-of-care analysis of drugs in patient saliva. This device will allow immediate assessment of both prescription and illicit drug use by patients with substance-related disorders (SRDs), and provide medical professionals and management with quantitative data so that treatment decisions can be made. The use of saliva will eliminate the chance of HIV infection associated with blood analysis for both patient and clinician. Successful treatments for SRD patients require frequent monitoring of both prescription and illicit drug use. Monitoring is mostly performed in outpatient settings (doctor's office, rehabilitation centers, etc.) employing urine samples and immunoassay test kits, which only provide qualitative information (yes/no). If a test is positive it is confirmed and quantified by gas chromatography coupled mass spectrometry (GC/MS), which often requires a blood sample. Unfortunately, immunoassay test kits are susceptible to false positives, while the GC/MS analysis is performed at clinical laboratories by highly trained operators, and results are usually not available for days. Consequently, there is a critical need for a device that combines the portability, speed and ease-of-use of immunoassay kits with the identification and quantitation abilities of GC/MS so that health care personnel can assess SRD patient compliance in outpatient settings. The proposed Saliva Drug Analyzer (SDA) will meet all such requirements by providing health care personnel with an easy-to-use device, which will extract, identify and quantify the presence of drugs (and metabolites) at requisite levels in saliva (10 through 10,000 ng/mL), within 10 minutes. During the Phase I program feasibility was demonstrate by developing a material that both separates drugs from saliva and generates SERS, and detecting two priority drugs, cocaine and diazepam in saliva from 25 to 10,000 ng/mL in 15 minutes. The overall aim of the Phase II program will be to develop and validate an SDA prototype so that it is ready for Phase III clinical trials. This will be accomplished by building the prototype and measuring actual patient samples through a subcontract with the Yale School of Medicine in conjunction with the Veterans Affairs Medical Center (VAMC), West Haven, CT.

Thesaurus Terms:
Base;Blood;Blood Capillaries;Blood Specimen;Capillary;Clinical;Cocaine;Compliance Behavior;Computer Software;Coupled;Data;Databases;Design;Devices;Diagnosis;Diazepam;Drug Of Abuse;Drug Targeting;Drug Testing;Drug Usage;Electronics;Gas Chromatography;Gel;Health Personnel;Hiv Infections;Illicit Drugs;Immunoassay;Laboratories;Letters;Libraries;Mass Spectrum Analysis;Measurement;Measures;Medical;Medical Center;Medical Schools;Meetings;Methods;Micro-Total Analysis System;Monitor;Optics;Outpatients;Patients;Performance;Performance Tests;Pharmaceutical Preparations;Phase;Phase Iii Clinical Trials;Point Of Care;Portability;Process;Programs;Prototype;Public Health Relevance;Raman Spectrum Analysis;Reagent;Rehabilitation Centers;Reporting;Reproducibility;Saliva;Sampling;Schedule;Small Business Innovation Research Grant;Speed (Motion);Substance Use Disorder;Substance-Related Disorders;Surface;System;Testing;Training;United States Food And Drug Administration;Urine;Veterans;Writing;