SannTek

Great question actually.

The device works well for vaped and smoked cannabis. We generally see peak concentration 10 minutes after smoking, and a steady decay to 0 over the next few hours.

We are in the midst of testing for edibles. What we would expect is that the concentration is lower and that peak concentration should occur 1-2 hours post consumption, followed by decay. We will see how it goes!

There is actually a lot of peer reviewed articles supporting the fact that cannabis impairs driving. Here are a few articles you might be interested in.

Ramaekers JG, Van Wel JH, Spronk DB, et al. Cannabis and tolerance: Acute drug impairment as a function of cannabis use history. Sci Rep. 2016;6(May):1-9. doi:10.1038/srep26843 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4881034/)

Veldstra JL, Bosker WM, De Waard D, Ramaekers JG, Brookhuis KA. Comparing treatment effects of oral THC on simulated and on-the-road driving performance: Testing the validity of driving simulator drug research. Psychopharmacology (Berl). 2015;232(16):2911-2919. doi:10.1007/s00213-015-3927-9 (https://www.ncbi.nlm.nih.gov/pubmed/25957748)

Micallef J, Dupouey J, Jouve E, et al. Cannabis smoking impairs driving performance on simulator and real driving: A randomized, double blind, placebo-controlled, crossover trial. Fundam Clin Pharmacol. 2018;(June). doi:10.1111/fcp.12382 (https://www.ncbi.nlm.nih.gov/pubmed/29752828)

Thanks for the comment.

Thanks for your comment. Here are a few research papers you might find interesting:

Ramaekers JG, Van Wel JH, Spronk DB, et al. Cannabis and tolerance: Acute drug impairment as a function of cannabis use history. Sci Rep. 2016;6(May):1-9. doi:10.1038/srep26843 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4881034/)

Veldstra JL, Bosker WM, De Waard D, Ramaekers JG, Brookhuis KA. Comparing treatment effects of oral THC on simulated and on-the-road driving performance: Testing the validity of driving simulator drug research. Psychopharmacology (Berl). 2015;232(16):2911-2919. doi:10.1007/s00213-015-3927-9 (https://www.ncbi.nlm.nih.gov/pubmed/25957748)

Micallef J, Dupouey J, Jouve E, et al. Cannabis smoking impairs driving performance on simulator and real driving: A randomized, double blind, placebo-controlled, crossover trial. Fundam Clin Pharmacol. 2018;(June). doi:10.1111/fcp.12382 (https://www.ncbi.nlm.nih.gov/pubmed/29752828)

You are totally correct that alcohol consumption results in far more fatalities and injuries than cannabis. A big part of this is how much more prevent alcohol is than cannabis. While around 70% of people report having used alcohol in the last year, only 20% report having used cannabis. However, this is changing as more and more people are using cannabis every year. I think we are going to see a long term trend were cannabis starts to close the gap with alcohol, at least where the drug is legal.

Nice name for the device! To be honest, neither of the founders are electronics or software people, we are nanotech engineers. I don't actually know how useful the source code would be for determining if our device is working as intended. We would certainly release information regarding how our device performs QC checks and have the device validated by a third party.

Excellent point. This is something we have talked about internally a lot. Early on, we are really testing whichever people we can get but when we move into a full clinical trial we are definitely going to design the study to be as diverse as possible. That is why we reached out to Curebase, to make sure the professionals were involved.

This comment comes from the fact that peak THC impairment occurs 1 hour post consumption (see the NHTSA Marijuana-Impaired Driving, A Report to Congress) and our average measurement at that time for THC in breath is around 0.00001 ppm. With alcohol, the cut off for impairment is 0.08% BAC which correlates to around 200 ppm of alcohol. So concentration of THC at the time of peak impairment is 0.00001 ppm whereas the concentration of alcohol is 200 ppm at the time of peak impairment. We did not mean to say 0.00001 ppm THC = 200 ppm of alcohol. We just wanted to illustrate the magnitude different in detecting both molecules. I guess it was not well worded :(.

It is not, but it does involve a gold substrate. We haven't found it necessary to include gold nanoparticles in order to achieve the required lower limit of detection.

Yes we have. We have filed in Canada, the US, and PCT.

We have tested vaping and smoking. We are in the process of testing tablets and edibles. Definitely a very important part of the equation.

Great idea!

We have actually been talking to a lot of TPAs (the organizations that do drug testing for industry). We have some interest, but unfortunately a lot of employers still have a stigma against cannabis. They are happy failing people for using the drug on the weekend because they really don't want drug users working for them. Hopefully this gets challenged in court soon, but until then we will need to do some educating.

Good question.

Our current device only screens to see if you used cannabis in the last 2-4 hours (which aligns with the approximate window of impairment for cannabis). It does not actually assign a degree of impairment to a particular concentration (ie if our device returns a higher concentration, it does not necessarily more impaired).

This is actually good for chronic users. In all our tests, both frequent and infrequent users had no detectable trace of THC left in their breath 3 hours after consumption. Therefore, our test does not discriminate between frequent and infrequent users in the same way blood does.

Confident that it will indicate, not necessarily confident that it will correlate (if that makes sense). The impairment window is approximately 2-3 hours post consumption. We can calibrate our sensor to have a threshold of detection that only triggers a positive if you smoked 2-3 hours ago. However, it is not clear that a higher concentration on our device would indicate higher impairment. More research is required to determine that.

Fair point. I think it is mostly a question of scale. Cannabis is the second most commonly used impairing substance after alcohol, and is becoming more prevalent every year. It would certainly be ideal to detect every impairing substance, but there are diminishing returns at some point.

That depends on how the research and regulation surrounding cannabis shake down.

Right now, our device would just be used as a screen to see if someone had used the drug recently. The device's results would not be taken to court and would likely be followed up with a blood or urine tests (not ideal, but that is what the courts accept these days).

Our device has the capacity to output a concentration, but more research into THC content in breath and impairment needs to be done to see if that concentration means anything. Likely, if a link between breath concentration and impairment is established, there will be a statutory concentration set for cannabis.

Good questions.

1. Our device does not detect CBD. It is specific to delta-9-THC. Our understanding is that CBD is not psychoactive and the police not interested in it.

2. As of yet, we have not seen any results from non-cannabis users on our device, some of whom were in the same room as our cannabis users when they used the drug. This will definitely be a focus of future tests for us, though. It would clearly be a huge problem if we returned positives from second hand smoke.

For one, it makes it difficult for federally funded entities since the federal government views it as illegal. Also, lots of funding for state entities comes from federal sources. I have also heard of researchers having trouble with institutional review boards that still follow the federal guidelines.

Thanks for the comment. Do you know if these numbers of for possession arrests or impaired driving arrests? I have been trying to look for the impaired driving arrest numbers but haven't had any luck yet.

One of the major roadblocks to legalization is fears surrounding public health risks, of which impaired driving is a component. We believe that by providing a device that makes policing cannabis impaired driving easier, we can help mitigate some of those fears. In that case, we hope the device would decrease possession arrests. As to whether or not our device would contribute to a disparity in impaired driving convictions between black and white American's, I am not 100% sure. Definitely something worth considering for us.

I urge you to read the report. I think it relays a very balanced accounting of the facts. Its also a good place to find all the studies in one document, so I don't have to send you 100 links!

Thanks for the comment!

Impairment is the big question surrounding the enforcement of driving under the impairment of cannabis. It varies much more than alcohol based on BMI, age, and use history. Here are a few good resources for understanding cannabis impairment and how it compares to alcohol.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2722956/ https://mass-cannabis-control.com/wp-content/uploads/2019/01...

One of the most prolific researchers in this space is Marilyn Huestis. Anything by her is really good.

Thanks for the info. Definitely something we have not run into or considered yet. I guess we just naively assumed that all police precincts were as scrupulous as those we talked to :(.

There is some stuff we can do, however. For instance, we can directly build the QC schedule into the device so it does not work unless you get it calibrated. We can also have QC cartridges that have a barcode that the device reads to make sure you actually ran a calibration check properly and the device passed.

We were so focused on internal methods for making the device accurate, but maybe we should put some thought into how we can make sure the police use it properly.

Good question, especially regarding the DrugTest 5000

There are definitely some clear competitors in this space, but we feel that non of them have really been able to address the needs of the market.

Ill start with the Draeger because it is close to my heart. This is the device that has been approved in Canada for roadside screening. This was such a massive mistake. The government gave out tons of funding for police precincts to buy these so of course they did. However, they simply are not being used. I spoke with the drug recognition expert at the first ever police precinct in Canada to buy these devices. They bought two, and the day after the Captain of the precinct told him not to use them. He put them under his desk and they have been there ever since. The problem with the DrugTest 5000 is it is the size of a microwave, needs to be on a level surface, and has accuracy issues especially with cannabis. And really, police officers hate having to swabs someone's mouth for two minutes to get a sample.

With respect to other saliva tests, some are better than the Drager, some are worse, but they all have the same kind of problems. The police hate using them because swabbing peoples' mouths is gross, time consuming, and problematic in terms of chain of custody for evidence. Police use them because they are the best road side screening tests available today, but they would drop them in a heart beat for something less invasive.

In terms of Hound Labs, we are not 100% sure what to think. We understand they have been around for much longer, but they have not been deployed in any police precincts in the US. I know they did some early pilots in California, but nothing seems to have come of them. In general, our main advantage over Hound Labs is cost and durability. Electrochemical immunosensors are very cheap and really robust. The same can generally not be said for the fluorescent approach being used by Hound Labs. In the end, we will see who can provide the best product for the police, but we are fairly confident we have the edge.

Several reasons. To begin, police have very long sales cycles that are tied to their funding schedule. You need to make sure that you engage with them when their budget has been assigned but they haven't allocated to much of it. They also are very stringent in making sure they buy the correct product. For most large purchases, they do what is called a "request for tenure" in which companies bid on a contract with a given police department, so you have to almost always compete directly with alternatives to your product.

Purchasing decision are distributive differently depending on the size of the police precinct, but in general it is the Chief of Police.

Great question.

The two main competitors to our product is Hound Labs and Cannabix (the one you linked). Our main advantages over these two companies are cost and durability (which is kind of a proxy for portability). These advantages mostly stem from our choice of technology for our sensor. Electrochemical immunosensors are very cheap and also do not require any delicate components. Hound Labs is using an fluorescent approach while Cannabix is using something called FAIMS. FAIMS especially is an incredibly complex and expensive technology that isn't really suited to the roadside.

There is a world in which our product is used for screening out in the field and the Cannabix product is used back at the station for more accurate testing. Our companies do have some compatibility that way.

Glad to see someone else from Waterloo in the comments! I'm not sure that what local police department serves your area, but the Waterloo Regional Police Service are actually really ahead of the curve when it comes to drug impaired driving. They have more drug recognition experts per capital than almost any other jurisdiction in Canada and if I am remembering correctly they are making it mandatory to train new recruits in the standard field sobriety tests.

They should still be listening to your complaints, however. Hope you have better luck in the future.

You raise a good point. Interestingly, your comments run contrary to what a lot of law enforcement officers have said to us.

In general, the police are hyper vigilant about buying only devices that are independently validated to be very accurate. Every conversation we have had has eventually lead to "is it NHTSA approved?". The reason for this need for third party validation is that the police are incredibly court room sensitive. If there is any chance a defense attorney would be able to pull out a study showing low specificity or sensitivity for a device, the police will simply not buy it. Third party validation gives them that guarantee.

You are right that the police want more convictions (or less time consuming convictions), but the way they do that is by having very accurate devices that are defensible in court, not inaccurate devices that risk cases being thrown out. That is why making sure our device has low false positive is very important.

Here is the source of the 80%-90% statistic: National Highway Traffic Safety Administration. Marijuana-Impaired Driving: A Report to Congress. July 2017.

The approximate window for cannabis impairment is 2-3 hours. Our sensor is currently calibrated to align with that window. The current threshold is around 10 pg/mL, although more trials are required to make sure that is the correct number.

Excellent point. The best solution to impaired driving would be a 100% accurate impairment test. The problem comes with designing and implementing such a test.

Let's start with what they have today, the standard field sobriety test. It is a pretty good test of impairment (with accuracy range between %75 to 90% depending on the study). However, there are several problems with the SFST. First of all, it requires police officers to be well trained and exercise their judgement roadside. This introduces the possibility for bias and the costs of training can sometimes be prohibitive. Secondly, the SFST cannot be administered in all conditions. A snowy day is a really bad time to be impaired, but also really difficult conditions for running a SFST.

The alternative is some kind of device that could detect the same (or different) markers of impairment as the SFST. The problem is making a device that is as accurate as the SFST, is portable, and easy to use is very difficult. If you look at attempts to date (like the Ocular DAX), these device tend to be really unwieldy and not even as accurate as the SFST. It seems like a technology that needs a little more time (maybe a decade?).

Overall though, definitely an avenue to explore.

Thank you for your feedback. It is really valuable to get the perspective of a frequent cannabis user. Cannabis tolerance is definitely a huge factor in determining whether or not someone is impaired. As a daily user, I am sure you are fine to drive after having used cannabis (although this is not legal advice :) ). However, people forget that there are significant tolerance effects for alcohol as well. There are people who can blow a 0.15% (well over the legal limit of 0.08%) and not exhibit any impairment symptoms. The key is finding a limit that allows police to identify actually impaired drivers while giving those with tolerance enough leeway to avoid being falsely charged. The scariest thing for frequent users is the blood legal limits being proposed in Canada and across the US, give that blood can have detectable levels of cannabis up to a week after abstinence. That is why one of our big focuses is finding a replacement for blood testing.

It depends on the jurisdiction. In general, the police begin with a roadside test. This is either an standard field sobriety test (walking in a straight line, touching your nose, etc) or a screening breathalyzer. If the person fails, they are arrested and taken to the station for further testing. This is either performed using a more accurate breathalyzer, or a blood test. In general, suspects can choose which test they want (blood or breath).

There is certainly a lot of confusion surrounding the effect of cannabis on driving. I would check out the report linked below. It provides a really good list of studies on cannabis and impairment along with summaries.

https://mass-cannabis-control.com/wp-content/uploads/2019/01...