The Need for Rapid and Reliable THC Testing Keeps Growing
As the legalization of Marijuana for medical and recreational purposes has proceeded rapidly through 34 US states, and in other countries such as Canada and Mexico, 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 DOT mandated transportation sector testing, 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 use disorder, but 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, sparing the healthcare system untold billions incurred for the cost of re-enrollment.
While law enforcement would prefer a “marijuana breathalyzer” based on their comfort and experience with alcohol breathalyzers, ∆9-TetraHydroCannabinol (THC), the primary physcoactive ingredient in marijuana, behaves quite differently than 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 attempting to miniaturize complex analytical instrument systems such as HPLC and MS in an effort to detect trace amounts of THC in the breath.
In addition to the technical challenge, as much as 25% of marijuana is consumed in the form of edibles, and THC from edibles is not detectable in 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, reportedly as high as 15%, as well as actual sample collection times of 10 minutes or more, despite published specifications of 1-2 minutes.
GINER’s Breakthrough Technology
Under funding from the USDOT and 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 over 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.