SBIR-STTR Award

Use of illicit drugs and abuse of licit counterparts are associated with multiple physical health, emotional, and interpersonal problems. Cardiovascular disease, stroke, cancer, HIV/AIDS, anxiety, depression, and sleep problems, financial difficulties and legal complications, work, and family problems can all result from or be exacerbated by drug abuse. In 2013, 21.6 million Americans were dependent on drugs or were drug abusers, representing 8.2% of our population aged 12 and over. While most had problems with only alcohol, 2.6 million has problems with illicit drugs and alcohol, and 4.3 million with illicit drug alone. Marijuana is the primary illicit drug with 4.2 million abusers or dependents, followed by pain relievers (1.9 million), cocaine (855,000) and heroin (517,000). Unfortunately, of the 21.6 million Americans who need substance use treatment, 20.2 million of them did not receive it. Furthermore, in the U.S. each year drug abuse and drug addiction cost employers over $122 billion in lost productivity time and another $15 billion in health insurance costs. Routine screening for substance use disorders could alter this statistic and get more people the help they need. Indeed, since the inception of medication-assisted treatment (MAT) for opioid addiction, drug testing has provided both an objective measure of treatment efficacy and a tool to monitor patient progress. Likewise, increasing emphasis on treatment outcomes as evidence of program effectiveness has added significance to drug tests in Treatment Programs (TPs), as well as use of drug test results in response to quality assurance requirements. Up to this juncture, drug testing in treatment settings has been limited to either remote drug testing via laboratory-confined procedures that take a long time to return results, or on-site urine testing strips that have limited multiplexing and semi-quantitative measurement capacities. There is, thus, a compelling need for an advanced point of care drug testing solution to be implemented within addiction treatment settings. Drug test results help policymakers and TP administrators detect and monitor emerging trends in substance abuse that may signal a need to redirect resources. Drug use patterns have changed markedly in recent decades; for example, benzodiazepines, amphetamines, methamphetamine, and cocaine have increased in popularity while barbiturate use has diminished. New substances of abuse or combinations of substances and methods of ingestion present new treatment challenges and funding concerns. Through this SBIR Phase I activity SensoDx will develop a microfluidics point-of-care diagnostic cartridge that, in conjunction with a miniaturized analyzer instrumentation, will permit real-time screening of cocaine and methadone drug users in treatment facilities. The aims of this project are to (1) Develop a triplex assay targeting simultaneous quantitative determination of buprenorphine, cocaine and morphine in saliva; (2) Analytically validate micro-assays for the three drugs in newly fashioned plastic ensemble cartridges; and (3) Establish the clinical utility of the new assay in a treatment program.

Public Health Relevance Statement:


Public Health Relevance:
By developing next-generation tools for onsite monitoring and treatment of drugs of abuse, this project will help millions of addicted Americans receive help for their illness, as well as save employers some of the $122 billion in lost productivity time and $15 billion in health insurance costs.

Project Terms:
addiction; Administrator; aged; Agreement; AIDS/HIV problem; Alcohol or Other Drugs use; Alcohols; American; Amphetamines; Analgesics; Antibodies; Anxiety; Applied Research; assay development; Barbiturates; base; Benzodiazepines; Biological Assay; Bovine Serum Albumin; Buprenorphine; Cardiovascular Diseases; Clinical; Cocaine; Cocaine Abuse; cost; Coupled; cross reactivity; Detection; Development; Devices; Dose; Drug abuse; Drug abuser; Drug Addiction; drug of abuse; Drug Targeting; drug testing; Drug usage; Drug user; Emotional; Ensure; Family; Funding; Health Insurance; Health Personnel; Heroin; Home environment; illicit drug use; Illicit Drugs; Ingestion; instrumentation; Laboratories; Lead; Legal; Liquid substance; Malignant Neoplasms; Marijuana; Measurement; Measures; Medical; medication-assisted treatment; Mental Depression; Methadone; Methamphetamine; Methods; Microfluidics; miniaturize; Monitor; Morphine; next generation; Noise; Opiate Addiction; Oral; Pathway interactions; Patient Monitoring; Patients; Pattern; Performance; Persons; Pharmaceutical Preparations; Pharmacotherapy; Phase; physical conditioning; point of care; point-of-care diagnostics; Population; Procedures; Productivity; Program Effectiveness; programs; public health relevance; quality assurance; Reagent; research study; Resources; response; Saliva; Sampling; screening; Secure; sensor; Signal Transduction; Site; Sleep Disorders; Small Business Innovation Research Grant; Staging; statistics; stroke; Substance abuse problem; Substance of Abuse; Substance Use Disorder; Technology; Test Result; Testing; Time; tool; Tracer; Treatment Efficacy; Treatment outcome; treatment program; trend; tv watching; United Kingdom; Urine; Validation; Work

Opioid abuse disorder (OAD) affects 2.1 million of Americans annually resulting in overdoses numbering in the tens of thousands and skyrocketing rates of mortality. In addition to its enormous social impact, OAD carries a multi-billion-dollar price tag that includes $78.5 billion, specifically for health care and other costs related to prescription opioid abuse and misuse. Although effective interventions exist, they are highly underutilized – Currently less than 1-in-5 Americans with prescription OUDs receive treatment for their disorder, the $2.8 billion spent accounting for less than 4% of the financial resources consumed by mismanagement of prescription opioid use. As treatment programs expand to meet need, it is critical that they be able to offer comprehensive services to best support patient recovery. Among potential treatment options for OAD, medication-assisted treatment (MAT) for opioid addiction – typically employing methadone, buprenorphine or naltrexone – has been shown to reduce withdrawal symptoms and is associated with reduced overdose risk and improved maternal and fetal outcomes in pregnancy. Since the inception of medication-assisted treatment (MAT) for opioid addiction, drug testing has provided both an objective measure of treatment efficacy and a tool to monitor patient progress, however, current methods are ill-suited for use in drug treatment settings. Liquid chromatography–tandem mass spectrometry (LC–MS-MS) is highly sensitive, but the method is slow to yield results and requires tedious sample processing. Easy to use immunochromatographic test strips (ICS) are gold-standard reference methods for point-of-care settings, but they are non-quantitative and have limited multiplexing capacity. A multiplexing tool is desirable for monitoring MAT because patients with OUD may have multiple opioids in their system over the course of treatment including the primary addictive opioid, treatment opioid, and less desirable substitutes for the addictive opioid of choice. Recognizing this unmet need in addiction treatment settings for a simple, yet sensitive, instrument that can measure multiple opioids in clinical specimens, SensoDx conceptualized a drug of abuse testing-on-a-chip strategy that implements microfluidics technology for high-sensitivity detection of opioids. In previous work (Phase I studies), we developed and clinically tested a triplex assay targeting simultaneous quantitative determination of buprenorphine, cocaine and morphine in oral fluid for use in buprenorphine-assisted treatment. This Phase II project will deliver a set of milestones – an optimized cartridge (precision, cost, size), expanded multiplexing capabilities to detection of seven drugs (buprenorphine, morphine, oxycodone, methadone, heroine, fentanyl, and cocaine), and pilot-scale clinical validation (in patients undergoing MAT) that will form the foundation and proof-of-concept for a prototype SensoDx Drug ScreenTM platform ready for design and fabrication finalization, GLP manufacturing and testing. The efforts will result in the commercial release of analyzer instrumentation, sampling devices and customized disposables for entry into the Lab-on-a- Chip market, valued at $4.23 Billion (in 2016) and expected to grow at a CAGR of 11% by 2022.

Public Health Relevance Statement:
Narrative Opioid abuse disorder affects millions of Americans annually and its enormous social impact carries a multi- billion-dollar price tag that includes medication-assisted treatment (MAT) for opioid addiction. Because current opioid-testing methods to monitor patients receiving MAT are ill-suited for point-of-care use, SensoDx developed and clinically tested (Phase I studies) a triplex assay targeting simultaneous quantitative determination of buprenorphine, cocaine and morphine in oral fluid samples for use in buprenorphine-assisted treatment. This Phase II project will optimize the platform technology for commercialization, expand its capabilities, and validate its clinical efficacy in monitoring patients undergoing MAT.

NIH Spending Category:
Behavioral and Social Science; Bioengineering; Brain Disorders; Clinical Research; Clinical Trials and Supportive Activities; Drug Abuse (NIDA only); Health Services; Opioid Misuse and Addiction; Opioids; Patient Safety; Prescription Drug Abuse; Substance Abuse

Project Terms:
Accounting; addiction; Affect; aged; American; Analgesics; Area; base; Biological Assay; Blinded; Buprenorphine; buprenorphine treatment; care outcomes; Caring; Clinical; clinical efficacy; Cocaine; cocaine use; college; commercialization; Computer software; Consumption; Correlation Studies; cost; Custom; Data; design; Detection; Devices; Disease; Dose; Drug Exposure; drug of abuse; Drug Targeting; drug testing; effective intervention; effective therapy; Ensure; Epidemic; Fentanyl; fetal; Focus Groups; Foundations; Gold; Health Services Accessibility; Healthcare; Heroin; heroin use; Heroin Users; illicit drug use; Improve Access; improved; instrument; instrumentation; Lab-On-A-Chips; Liquid Chromatography; Liquid substance; Measurement; Measures; Medical; medication-assisted treatment; Medicine; Methadone; Methods; microdevice; microfluidic technology; Monitor; Morphine; mortality; Naltrexone; next generation; nonmedical use; Opiate Addiction; Opioid; opioid abuse; opioid epidemic; opioid misuse; opioid mortality; opioid use; opioid use disorder; opioid user; Optics; Oral; Outcome; Overdose; overdose risk; Oxycodone; Patient Monitoring; Patients; Performance; personalized medicine; Persons; Pharmaceutical Preparations; Pharmacotherapy; Phase; phase 1 study; point of care; portability; Pregnancy; prescription opioid; prescription opioid abuse; prescription opioid misuse; Prescription opioid overdose; Price; Privatization; programs; prototype; Provider; Recovery; Reference Standards; Research; Resources; response; Saliva; Sampling; sensor; Services; Site; Social Impacts; Specimen; Substance Abuse Detection; System; tandem mass spectrometry; Technology; technology development; Testing; Time; tool; Treatment Efficacy; treatment program; United States Dept. of Health and Human Services; United States National Institutes of Health; Urine; Validation; Withdrawal Symptom; Work