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Giner is developing both a THC breathalyzer and a saliva-based sensor; both have proven performance ahead of any other available technology and will come to market at dramatically lower price points.
With the legalization of marijuana for medical and recreational purposes proceeding rapidly across North America and around the world, there is growing pressure from law enforcement and the general population for a portable, rapid roadside test to determine if drivers are driving under the influence of marijuana.
Such a test would also be useful for US Department of Transport (USDOT) mandated routine testing of commercial drivers and airline pilots, and possibly in the clinical justice system for offender monitoring.
In addition, over 30% of new entrants into drug abuse treatment and recovery problems are for the treatment of cannabis abuse, and rates of recidivism are in excess of 95%. Monitoring of patients during and after treatment with an easy-to-use test could improve the rates of recidivism, reducing the extraordinary burden of the cost of repeated program enrollments on the healthcare system.
While law enforcement would prefer a “marijuana breathalyzer” based on their comfort and experience with alcohol breathalyzers, ∆9-TetraHydroCannabinol (THC), the primary psychoactive ingredient in marijuana, is quite a different beast from alcohol with respect to pharmacokinetic distribution and ease of detection. Unlike alcohol, which is water soluble and readily passes into the blood and lungs, THC is fat soluble and much harder to detect. Peak concentrations in breath occur within 30 minutes after smoking, and drop to virtually undetectable levels within two hours.
For these reasons, several organizations have undertaken the virtually insurmountable challenge of miniaturizing complex analytical instrument systems such as high performance liquid chromatography (HPLC) and mass spectrometry (MS) in an effort to reliably detect trace amounts of THC in the breath.
In addition to the technical challenges, as much as 30% of marijuana consumed is in the form of edibles, and THC from edibles is not detectable in the breath.
Given the technical challenges of breath detection, and limitations with regards to edibles, commercially available saliva based tests have emerged, and are currently favored by legislative bodies in several states, and approved for use in Canada and several other countries. These tests are based on immunoassays, and the interaction of THC with antibodies. The test strip or cassette used with these instruments changes color if THC is present in the sample at levels of 5ng/ml or higher.
Unfortunately these instruments are expensive, with retail market prices of $4,000 - $6,000 each, and one particular model at about the size of a shoebox isn’t exactly portable. In addition, they have a significant incidence of false positives, as well as actual sample collection times of 10 minutes or more, despite published specifications of 1-2 minutes, or 2-4 minutes.
Under funding from the US Department of Transportation (USDOT) and the National Institutes of Health (NIH), Giner has developed patent pending electrochemical sensors for the direct detection of THC in Saliva and Breath, bypassing the technical hurdle of attempting to miniaturize analytical instrumentation, and eliminating the false positives that can occur with immunoassay based tests. In addition, we have demonstrated detection limits of 1ng/ml in the breath and saliva of human subjects, even though they only smoked marijuana cigarettes with THC levels in the range of 3-7%, compared to levels of 30-40% typically found in street marijuana.
These preclinical results will soon be validated in a larger clinical study at the Brown University Center for Addiction Studies.
Due to the use of electrochemical technology, which already exists in a miniaturized state, Giner’s Marijuana Tests will offer several compelling competitive advantages:
- Greatly reduced sample collection and analysis time
- Direct detection of THC at extremely low levels
- Dramatically lower price point
- Much smaller form factor
We are presently seeking external funding or a strategic partnership to accelerate development and bring this game changing technology to market.
Please contact our Vice President of Business Development, Ed Hogan, for more details.