Giner, Inc. SBIR Phase II Award, February 2019

PROJECT SUMMARY/ABSTRACT Marijuana Breath Analyzer The overall goal of this program is a THC breath analyzer that will provide rapid, accurate, and non-invasive determination of recent marijuana use at point-of-collection testing (POCT). Authorities will obtain breath samples noninvasively as they currently do in alcohol testing and receive the results on the spot. This field device for enforcement will deter drivers from driving under the influence of marijuana and thereby reduce the associated increase in traffic accidents protecting both individual and public safety. The monitor can also be used in substance abuse research, medical screening and employment testing. In Phase I Giner successfully established a methodology for THC measurement with excellent reproducibility and accuracy for measuring THC in spiked solutions. THC was also successfully measured in breath samples from cannabis smokers. All subject breath samples containing THC (from smoking 3% and 7% cigarettes) have shown detectable THC and none of the placebos (0%) showed any net signal. Phase II will include continued measurement algorithm optimization, design and fabrication of a prototype to perform extensive breath testing from human subjects to calibrate and validate the sensor against gold standard lab method with regards to stability, reliability, and reproducibility. The Phase II program will recruit a larger number of human subjects (n=65), obtaining samples at several points in time for high resolution monitoring of THC in breath, that will also correlate breath THC levels with impairment to guide the breath analyzer’s use in roadside and clinical applications. Giner’s THC breath test device will fill the urgent unmet need and be the alternative to the current expensive and time-consuming analytical techniques which have a turn-around time of several days. It will be suitable for use in: 1) onsite tests relating to DUI; 2) workplace, military and patient screening; 3) criminal justice applications; 4) drug abuse treatment programs; and 5) clinical research. The existence of a court-admissible field test will deter drivers from driving under the influence of marijuana protecting both individual and public health.PROJECT NARRATIVE The Giner marijuana breath analyzer being developed will provide rapid, accurate, and non-invasive determination of recent marijuana use. When used as a field device for enforcement, it will deter drivers from driving under the influence of marijuana and thereby reduce the associated increase in traffic accidents protecting both individual and public safety. The clinical study utilizing the Giner breath analyzer will provide a sound basis for the use of this analyzer in driving enforcement, substance abuse research, medical screening and employment testing. The project will also determine the relationship between marijuana-induced performance impairment and THC (the active ingredient in marijuana) concentrations in breath.