Project Summary/Abstract Wearable sensor for opioids detection based on electrochemical sensor array integrated with Bluetooth device In this Phase II project, we will develop a new electrochemical sensor array with ultra- high sensitivity (ng/mL limit of detection), enhanced drug specificity, long-term durability, low power consumption, and cost-effective production. By the end of Phase II, 20 devices (along with 42 sensory cartridges for each) will be produced and ready for commercialization (TRL 9) upon completion of Phase II. To provide an ultra-high sensitivity, nanoporous silicon will be employed as a substrate for the working electrode. Additionally, advancements of the approach include a high level of integration of all functional modules on one microchip, wireless communication with user interface (smartphone, computer), low cost and maintenance through long-term durability, low power consumption, and cost-effective production. The specific aims of Phase II are as follows: • Develop a prototype of the sensory wearable device, which comprises an electrochemical sensor array tuned to six target opioids and six non-opioid narcotics • Demonstrate that the prototype is capable of narcotic detection with ultra-high sensitivity (within ng/L range) and high selectivity/low cross-reactivity • By the end of Phase II, produce 20 devices (TRL 9) ready for commercialization In Phase II, the prototype of the wearable device will be further optimized and developed to the level of commercial readiness. Major objectives of Phase II include optimization of individual sensors to the lowest limit of detection and fabrication of two interchangeable sensory cartridges for six opioids and six non-opioid narcotics; integration of the sensory module with the printed circuit board for data conditioning, processing, and wireless transmittance; two-level trials with human subjects; submission of an FDA application; fabrication of 20 devices and cartridges ready for commercialization (TRL 9); patent filing; and establishing contacts with end-users, purchasers and venture groups so that product commercialization can be started after Phase II (we will use the company profit for sales and marketing).

Project Narrative The goal of this Phase II proposal is to develop a commercially viable wearable device as a forearm bracelet, for rapid, on-site testing for opioids and other narcotics with wireless alerts. We demonstrated the feasibility of this approach in Phase I. The Phase II effort will focus on further development and optimization to provide ultra-high sensitivity (ng/mL detection range), enhanced drug specificity, long-term durability, low power consumption, and cost-effective production. Upon completion of Phase II, 20 devices will have been produced and will be ready for commercialization.