Rapid and non-invasive device for drug detection through sweat

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Project Summary 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.