SBIR-STTR Award

In this NIDA SBIR Phase I project, Arborsense will develop a portable sweat-based screening device for rapid, non-invasive, point-of-need, and quantitative detection of drugs of abuse. The use and abuse of potentially- addictive substances has become a national crisis with immense social (>67,000 deaths every year) and economic costs (~$200B annually). Consequently, regular drug-use testing and monitoring have become key components of the management strategies to control this epidemic. Within most settings whether clinical, roadside tests, workplace monitoring, or court-ordered compliance, having reliable and timely data on drug use is essential. However, the available strategies to detect drug use which rely on testing blood, urine, saliva, hair, breath, and sweat, are plagued by cumbersome collection methods and significant delays in receiving test results, thus hampering the ability to provide up-to-date objective data on recent drug use. In this project, Arborsense proposes to develop a sweat-based portable and inexpensive drug detection device using our technology based on microfluidic competitive enzyme-linked immunosorbent assay where sweat will be collected on the front panel and quantitative results will be available within a few minutes. In preliminary studies, we have demonstrated rapid and quantitative detection of drugs/opioids in artificial sweat. For this Phase I study, Arborsense will collaborate with the University of Michigan to develop and validate our portable sweat-based drug detector. First, we will design, test, optimize and automate a miniaturized drug detection unit integrated with sweat generation and collection modules. Next, we will validate the device and protocol on 20 human participants who are seeking treatment for a drug use disorder and benchmark the results with urine drug screens and self- reported data. A high degree of concordance between Arborsense's device, urine test, and self-reported data will confirm the feasibility of our proposed project, and will lead to a Phase II SBIR application to optimize the device for field use which can then be evaluated in large scale clinical studies. Our envisioned product will address the unmet need for a non-invasive, real-time, quantitative, point-of-use, and convenient device for rapid detection of use/abuse of multiple drugs. Such a device has applications related to all points along the spectrum of severity of drug use problems and will help augment prevention and treatment strategies, enhance health, and reduce illness and disability.

Public Health Relevance Statement:
Project Narrative More than 7 million individuals in the United States suffer from a drug use disorder (both prescription and non- prescription). Coinciding with the substantial increase in the use and misuse of opioids over the past decade, accidental deaths due to drug overdose have now surpassed deaths due to car crashes and gun violence to become the leading cause of death for Americans under 55. This Phase I project is aimed at developing a portable sweat-based drug screening device that will address the unmet need for a non-invasive, real-time, quantitative, point-of-use, and convenient device for rapid detection of use/abuse of multiple drugs.

Project Terms:
Amphetamines; Desoxynorephedrin; Phenamine; Phenopromin; dl-Amphetamine; Biological Assay; Assay; Bioassay; Biologic Assays; Buprenorphine; Cause of Death; Clinical Research; Clinical Study; Cocaine; Data Reporting; data representation; Cessation of life; Death; Drug Use Disorder; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Enzyme-Linked Immunosorbent Assay; ELISA; Epidemic; Hair; Health; Blood Tests; Hematologic Tests; Hematological Tests; Hematology Testing; Hospitals; Human; Modern Man; Lead; Pb element; heavy metal Pb; heavy metal lead; Mental Health; Mental Hygiene; Psychological Health; Methadone; Adanon; Althose; Dolophine; Methadose; Methamphetamine; Crystal Meth; Deoxyephedrine; Desoxyephedrine; Methylamphetamine; N-Methylamphetamine; Methods; Michigan; Biological Models; Biologic Models; Model System; Overdose; Legal patent; Patents; Patients; Public Health; Publications; Scientific Publication; Saliva; Substance Abuse Detection; Drug Abuse Detection; Drug Abuse Screening; Drug Abuse Testing; Substance Abuse Testing; substance abuse screening; Technology; Testing; Tetrahydrocannabinol; 9-ene-Tetrahydrocannabinol; Delta-9-Tetrahydrocannabinol; delta(1)-THC; delta(1)-Tetrahydrocannabinol; delta(9)-THC; delta(9)-Tetrahydrocannabinol; Δ(1)-THC; Δ(1)-tetrahydrocannabinol; Δ(9)-THC; Δ(9)-tetrahydrocannabinol; Δ-9-tetrahydrocannabinol; Δ9-tetrahydrocannabinol; Time; United States; Universities; Urine; Urine Urinary System; Weight; Work; Generations; Caring; Job Location; Job Place; Job Setting; Job Site; Work Location; Work Place; Work-Site; Worksite; work setting; Workplace; base; court; detector; sensor; Clinical; Phase; Ensure; disability; Individual; Opiates; Opioid; drug use; Drug usage; tool; Sweat screening test; sweat analysis; Sweat test; Severities; Home; Home environment; Protocol; Protocols documentation; System; Test Result; Best Practice Analysis; Benchmarking; Emergency Department; Emergency room; Accident and Emergency department; American; success; Participant; Preventative strategy; Preventive strategy; Prevention strategy; sober; sobriety; economic cost; Self-Report; Patient Self-Report; Categories; Devices; Reporting; social; Sampling; miniaturize; portability; µfluidic; Microfluidics; Address; Consent; Data; Detection; NIDA; National Institute on Drug Abuse; National Institute of Drug Abuse; Collection; SBIR; Small Business Innovation Research; Small Business Innovation Research Grant; Monitor; rapid detection; designing; design; firearm violence; gun violence; Consumption; Automobile collision; Automobile crash; Car collision; Car crash; Motor vehicle collision; Motor vehicle crash; Vehicular collision; Vehicular crash; Vehicle crash; abused drug; abused drugs; drug abused; drugs abused; drugs of abuse; drug of abuse; drug detection; drug testing; eligible participant; addictive disorder; addiction; primary care setting; treatment strategy; effective treatment; effective therapy; treatment adherence; drug use screening; Phase I Study; phase 1 study; screening; cannabis legalization; legal marijuana; legalized cannabis; legalized marijuana; marijuana legalization; opiate use disorder; opioid use disorder; opiate crisis; opioid crisis; opioid epidemic; opiate therapy; opioid therapy; recruit; Drug Screening; non-medical opioid use; nonmedical opioid use; opiate misuse; opioid misuse

In this NIH SBIR Phase II project, Arborsense will continue its successful line of work to develop a portable sweat-based screening device to address the unmet need for a rapid, non-invasive, and quantitative device for detection of drugs of abuse at point-of-need. The use and abuse of potentially addictive substances has become a national crisis. The tremendous social (100,000 deaths reported by CDC between April 2020 and April 2021) and economic ($400B annually in healthcare, work productivity, and crime) costs related to the substance abuse and misuse call for an urgent focus on implementing and supporting health approaches to reduce the loss of life and financial burden inflicted. Regular drug-use testing and monitoring are key components of the management strategies to control this epidemic. Within most settings whether clinical, court-ordered, treatment centers, workplace monitoring, or roadside testing, having reliable and timely data on drug use is essential. However, the available strategies to detect drug use which rely on testing blood, urine, saliva, hair, breath, and sweat, are plagued by cumbersome collection methods and significant delays in receiving test results, thus hampering the ability to provide up-to-date objective data on recent drug use. Based on the preliminary study on rapid and quantitative detection of 4 drugs/opioids in artificial sweat, Arborsense received a NIDA Phase I SBIR (R43 DA052941) award. In Phase I, we: (1) expanded the panel to 5th drug - Buprenorphine, (2) optimized the sweat analysis protocol, (3) developed sweat generation and sweat collection modules, and (4) validated the detector in a human subjects' study (n=16) benchmarking it with a urine drug screen where we demonstrated point-of- need generation (5 minutes) and collection (15 minutes) of 20 µL of sweat and subsequent detection (20 minutes) of 5 drugs with detection limits of 1-3 ng/mL. Based on these results, in Phase II Arborsense will further optimize the overall device design and workflow to develop a truly portable robust prototype and benchmark it with the industry-standard LC-MS (liquid chromatography coupled with mass spectrometry) in a large-scale human subjects' study (n=50). Specifically, we will reduce the size of the sweat generator to a hand-held unit and sweat detector to a shoebox size unit. We will automate the microfluidic flow to eliminate mechanical moving parts and optimize the unit to target a start-to-finish time of 25 minutes. The overall design will also reduce multiple manual touchpoints for ease-of-operation. In Phase II, Arborsense will collaborate with Biomedical Engineering and Department of Psychiatry at University of Michigan to design, co-develop, and validate the portable sweat-based detector in a large-scale human study. We will also engage with our strategic industry partners during the design process to incorporate features necessary for market acceptance. Good correspondence between our detector and LC-MS measurements will confirm the technical and commercial feasibility of our detector, which can then be provided to industry partners for testing and pitched to investors.

Public Health Relevance Statement:
Project Narrative The U.S. drug epidemic reached a terrible milestone when the CDC announced that more than 100,000 people had died of drug overdoses between April 2020 and April 2021; the first time that drug-related deaths have reached six figures in any 12-month period. More than 18 million individuals suffer from a drug use disorder (both prescription and non-prescription) in the United States. Through this Phase II project, Arborsense will build on a successful prior NIDA Phase I SBIR to continue the development of a portable sweat-based drug detector to address the growing need for an accurate, non-invasive, and stigma-free device for rapid and quantitative detection of drugs at the point-of-use.

Project Terms:
Amphetamines; Desoxynorephedrin; Phenamine; Phenopromin; dl-Amphetamine; Award; Biological Assay; Assay; Bioassay; Biologic Assays; Biomedical Engineering; bio-engineered; bio-engineers; bioengineering; biological engineering; Biomedical Research; Buprenorphine; Centers for Disease Control and Prevention (U.S.); CDC; Centers for Disease Control; Centers for Disease Control and Prevention; United States Centers for Disease Control; United States Centers for Disease Control and Prevention; Liquid Chromatography; Crime; Data Reporting; data representation; Cessation of life; Death; Drug Use Disorder; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Economics; Enzyme-Linked Immunosorbent Assay; ELISA; enzyme linked immunoassay; Epidemic; Hair; Hand; Health; Blood Tests; Hematologic Tests; Hematological Tests; Hematology Testing; Hospitals; Human; Modern Man; Iontophoresis; Drug Iontophoresis; iontophoresis therapy; Lead; Pb element; heavy metal Pb; heavy metal lead; Manuals; Methadone; Adanon; Althose; Dolophine; Methadose; Methamphetamine; Crystal Meth; Crystal methamphetamine; Deoxyephedrine; Desoxyephedrine; Methylamphetamine; N-Methylamphetamine; Methods; Michigan; Persons; NIH; National Institutes of Health; United States National Institutes of Health; Out-patients; Outpatients; Overdose; Patients; Pilocarpine; Productivity; Psychiatry; Public Health; Reagent; Safety; Saliva; Mass Photometry/Spectrum Analysis; Mass Spectrometry; Mass Spectroscopy; Mass Spectrum; Mass Spectrum Analyses; Mass Spectrum Analysis; Drug Abuse Detection; Drug Abuse Screening; Drug Abuse Testing; Substance Abuse Testing; substance abuse screening; Substance Abuse Detection; Technology; Testing; 9-ene-Tetrahydrocannabinol; Delta-9-Tetrahydrocannabinol; delta(1)-THC; delta(1)-Tetrahydrocannabinol; delta(9)-THC; delta(9)-Tetrahydrocannabinol; Δ(1)-THC; Δ(1)-tetrahydrocannabinol; Δ(9)-THC; Δ(9)-tetrahydrocannabinol; Δ-9-tetrahydrocannabinol; Δ9-tetrahydrocannabinol; Tetrahydrocannabinol; Time; United States; Universities; Urine; Urine Urinary System; Work; Generations; Drug Monitoring; Device Designs; Healthcare; health care; Caring; Workplace; Job Location; Job Place; Job Setting; Job Site; Work Location; Work Place; Work-Site; Worksite; work setting; base; court; human subject; detector; Pump; Clinical; Phase; Ensure; Individual; Withdrawal; Opiates; Opioid; Measurement; drug use; Drug usage; Funding; tool; Knowledge; Life; mechanical; Mechanics; Sweat screening test; sweat analysis; Sweat test; Protocol; Protocols documentation; Test Result; Best Practice Analysis; Benchmarking; interest; Emergency Department; Emergency room; Accident and Emergency department; field based data; field learning; field test; field study; Performance; success; Participant; sober; sobriety; Study Subject; Self-Report; Patient Self-Report; Devices; Reporting; social; abuse of substances; substance abuse; Substance abuse problem; Sampling; stigma; social stigma; portability; µfluidic; Microfluidics; telehealth; Address; Consent; Core Facility; Data; Detection; NIDA; National Institute on Drug Abuse; National Institute of Drug Abuse; Collection; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Monitor; Process; Development; developmental; cost; treatment center; rapid detection; design; designing; human study; Coupled; clinically relevant; clinical relevance; drug testing; drug detection; eligible participant; addiction; addictive disorder; prototype; commercialization; treatment adherence; industry partner; industrial partnership; industry partnership; drug use screening; operation; screening; marijuana legalization; cannabis legalization; legal marijuana; legalized cannabis; legalized marijuana; marijuana use; THC co-use; THC use; Tetrahydrocannabinol co-use; Tetrahydrocannabinol use; cannabis use; methamphetamine use; METH use; Industry Standard; amphetamine use; substance misuse; recruit; Drug Screening; Financial Hardship; financial burden; financial distress; financial strain; financial stress; remote monitoring; substance use treatment; detection limit; substance use; substance using; COVID-19 impact; COVID-19 affected; COVID-19 consequence; COVID-19 effect; COVID-19 impacted; coronavirus disease 2019 consequence; coronavirus disease 2019 effect; coronavirus disease 2019 impact; coronavirus disease-19 impact; abuse liability; abuse potential