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 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 toperform discreet and unobtrusive monito ring of BAC, but available devices are still lacking reliability, accuracy and sensitivity. In this context, Bioinspira, Inc. has developed a versatile bacteriophage-based, colorimetricsensor platform technology for gas sensing. The novel, in-house developed technology uses a self-assemblingbacteriophage sensor array (M13 bacteriophage) that can be genetically engineered to bind to specific gasmolecules and change its color pattern based on type of gas and concentration. By leveraging this innovativetechnology, through this SBIR phase I study Bioinspira will assess the feasibility of realizing a wearableBiomimetic Sensor for Transdermal Alcohol Monitoring (BiosTAM) for real-time monitoring of ethanol vapor thatevaporates through the skin. Preliminary laboratory data showed the ability of BioInspira's platform technologyto detect ethanol. The development of a phage-based ethanol sensor with high will fill a technological gap inalcohol behavior monitoring, enabling more comprehensive and detailed medical studies, and will offer thepossibility to monitor and manage personal alcohol use disorder. In SBIR Phase I, the technical feasibility ofdetecting ethanol vapor selectively, sensitively and real-time will be assessed. To this extent, the following R&Dactivities will be conducted: 1. Production and evaluation of gas phage array candidates for the selective andsensitive detection of ethanol vapor; 2. Calibration of the best performing phage sensor candidate for thedetection of ethanol concentration under different temperature and relative humidity conditions. The resultsobtained will be preparatory for a SBIR Phase II, where the clinical trials will be performed for the correlation oftransdermal alcohol measurements with BAC.
Keywords: Alcoholism, Alcohol abuse, wearable biosensor, phage, perspired ethanol, alcohol vapor. PROJECT NARRATIVE 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. Adult ; 21+ years old ; Adult Human ; adulthood ; Air ; alcohol use disorder ; ethanol use disorder ; Ethanol ; Absolute ethanol ; ETOH ; Ethyl Alcohol ; Grain Alcohol ; Methylcarbinol ; Alcoholic Intoxication ; Alcohol Intoxication ; Drunkenness ; EtOH intoxication ; ethanol intoxication ; Alcohols ; Alcohol Chemical Class ; Automobiles ; Bacteriophages ; Phages ; bacterial virus ; Calibration ; Color ; Economics ; Electronics ; electronic device ; Fingerprint ; Gases ; Genetic Engineering ; Genetic Engineering Biotechnology ; Genetic Engineering Molecular Biology ; Recombinant DNA Technology ; genetically engineered ; Government ; Health ; Human ; Modern Man ; Humidity ; Industry ; Laboratories ; Libraries ; Longevity ; Length of Life ; life span ; lifespan ; mortality ; Nitrogen ; Optics ; optical ; Production ; Productivity ; Proteins ; Reaction Time ; Response RT ; Response Time ; psychomotor reaction time ; Research ; research and development ; Development and Research ; R & D ; R&D ; Risk Factors ; Safety ; Self Assessment ; Surveys ; Survey Instrument ; Technology ; Temperature ; Testing ; Time ; United States ; Virus ; Water ; Hydrogen Oxide ; Measures ; Medical Research ; Health Care Costs ; Health Costs ; Healthcare Costs ; Alcohol abuse ; EtOH abuse ; alcohol co-abuse ; alcohol problem ; ethanol abuse ; hazardous alcohol use ; problem alcohol use ; problem drinking ; problematic alcohol consumption ; problematic alcohol use ; Risk Assessment ; Bacteriophage M13 ; Coliphage M13 ; Enterobacteria phage M13 ; M13 Phage ; Workplace ; Job Location ; Job Place ; Job Setting ; Job Site ; Work Location ; Work Place ; Work-Site ; Worksite ; work setting ; base ; Blood specimen ; Blood Sample ; sensor ; alcohol measurement ; ETOH level ; alcohol level ; ethanol measurement ; ethyl alcohol measurements ; Clinical ; Phase ; Medical ; Evaluation ; disability ; Individual ; Databases ; Data Bases ; data base ; Drug usage ; drug use ; chemical property ; Phase II Clinical Trials ; Phase 2 Clinical Trials ; phase II protocol ; lightweight ; light weight ; tool ; Pattern ; System ; Blood Alcohol Content ; blood alcohol concentration ; blood alcohol level ; Blood alcohol level measurement ; interest ; innovative technologies ; Receptor Protein ; receptor ; success ; vapor ; biological sensor ; Biosensor ; ethanol sensitivity ; sensitivity to alcohol ; sensitivity to ethanol ; alcohol sensitivity ; novel ; Devices ; response ; Biological Mimetics ; Biomimetics ; Skin ; Cell Phone ; Cellular Telephone ; iPhone ; smart phone ; smartphone ; Cellular Phone ; Molecular Interaction ; Binding ; Thickness ; Thick ; Affinity ; Data ; Detection ; Direct Costs ; Economic Burden ; Resolution ; Facilities and Administrative Costs ; Indirect Costs ; Phage Display ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Wireless Technology ; wireless ; Monitor ; Process ; Development ; developmental ; environmental change ; cost ; Behavior monitoring ; behavioral monitoring ; design ; designing ; high risk drinking ; at-risk drinking ; risky drinking ; Consumption ; drinking behavior ; Alcoholism ; innovation ; innovate ; innovative ; alcohol behavior ; alcohol induced behavior ; alcohol related behavior ; ethanol behavior ; ethanol induced behavior ; ethanol related behavior ; alcohol monitoring ; volatile organic compound ; volatile organic chemical ; alcohol risk ; phase 1 study ; Phase I Study ; Preventive measure ; Preventative measure ; wearable sensor technology ; body sensor ; body worn sensor ; wearable biosensor ; wearable sensor ; wearable system ; wireless sensor technology ; wearable device ; wearable electronics ; wearable technology ; real time monitoring ; realtime monitoring ; Atmosphere ;
