According to the 2015 National Survey of Drug Use and Health (NSDUH), 15.1 million adults had alcohol use disorder in the United States. Alcoholism has been identified as an important risk factor for illness, disability, and mortality, carrying a huge economic and societal burden. Real-time, accurate and discreet devices for the assessment of Blood Alcohol Concentration (BAC) are essential to empower medical research with reliable reliable means to monitor alcohol behavior, as well as for effective personal self-assessment. Measurement of ethanol perspired through the skin by means of wearable devices is of particular interest for the possibility to perform discreet and unobtrusive monitoring of BAC, but available devices are still lacking reliability, accuracy and sensitivity. In this context, Bioinspira, Inc. has developed a versatile bacteriophage-based, colorimetric sensor platform technology for gas sensing. The novel, in-house developed technology uses a self-assembling bacteriophage sensor array (M13 bacteriophage) that can be genetically engineered to bind to specific gas molecules and change its color pattern based on type of gas and concentration. By leveraging this innovative technology, through this SBIR phase I study Bioinspira will assess the feasibility of realizing a wearable Biomimetic Sensor for Transdermal Alcohol Monitoring (BiosTAM) for real-time monitoring of ethanol vapor that evaporates through the skin. Preliminary laboratory data showed the ability of BioInspira?s platform technology to detect ethanol. The development of a phage-based ethanol sensor with high will fill a technological gap in alcohol behavior monitoring, enabling more comprehensive and detailed medical studies, and will offer the possibility to monitor and manage personal alcohol use disorder. In SBIR Phase I, the technical feasibility of detecting ethanol vapor selectively, sensitively and real-time will be assessed. To this extent, the following R&D activities will be conducted: 1. Production and evaluation of gas phage array candidates for the selective and sensitive detection of ethanol vapor; 2. Calibration of the best performing phage sensor candidate for the detection of ethanol concentration under different temperature and relative humidity conditions. The results obtained will be preparatory for a SBIR Phase II, where the clinical trials will be performed for the correlation of transdermal alcohol measurements with BAC. Keywords: Alcoholism, Alcohol abuse, wearable biosensor, phage, perspired ethanol, alcohol vapor.
Alcohol abuse and alcoholism claim each year in the United States an estimated 100,000 lives. BioInspira is developing a wearable alcohol biosensor for real-time based on a proprietary versatile bacteriophage-based, colorimetric sensor platform technology for gas sensing. The project is expected to introduce a novel and innovative system to monitor and manage alcohol behavior.
