Rapid and non-invasive device for drug detection through sweat

Project Summary In the 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 (~93,000 deaths in 2020) and economic costs (~$400B 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. In the NIH I-Corps program, we will interview 100 individual stakeholders in the ecosystem to test our hypotheses on the market pain-points, target entry market, product needs, competition, and revenue model. The feedback gained from the I-Corps program will be used to refine and realign our existing business plan to maximize commercialization success.