Introducing the Smoke Signature Assay: Improving smoking cessation research and success


Are you a life-science researcher interested in helping rid the world of smoking? Or a psychiatrist hoping for improvements to the current methods of assessing patients in smoking cessation therapy? Now imagine a tool that uses saliva to quantify the exact number of cigarettes a patient has consumed. Read the interview below of Dr. Rob Philibert describing a new product developed by Behavioral Diagnostics and provided by IBI Scientific, approved for smoking cessation research purposes, and its many benefits.

What is the Smoke Signature Assay?

The Smoke Signature Assay is an epigenetic assay that is capable of detecting the presence and quantifying the degree of cigarette smoking.


How does the Smoke Signature Assay work?

The basis of the assay is that it quantifies the polyaromatic hydrocarbon in cells in the saliva or blood of patients and subjects.


In what ways is it better than the current and accepted methods?

Current technologies are easy to fool and are neither sensitive nor specific for smoking. The most commonly given test for smoking is exhaled carbon monoxide. The problem with carbon monoxide testing is, in order to fool the test, all you have to do is not smoke for two to three hours and your carbon monoxide goes back down to baseline levels. But more importantly, there are a lot of false positives. People with lung disease show elevated carbon monoxide. People who work in certain environments suffer from false positives. The alternative and preferred test by most clinicians is the serum urine or salivary cotinine test. The cotinine test is probably more sensitive to the presence of smoking but once again, it has a lot of false positives. For instance, conceivably, if you are around someone who smokes, you can appear cotinine positive.

All cotinine measures is nicotine metabolism—but nicotine can come from things other than tobacco. For instance, from vaping or use of the nicotine patch. In order to develop a laboratory or clinical test that is sensitive for smoking, what we have to do is be sure that we have a test that can differentiate from those who are in treatment and those who are failing treatment. Since 90% of patients that use pharmacological treatment for smoking cessation use the nicotine patch or nicotine gum, physicians cannot use a cotinine test to determine whether they are succeeding or failing at smoking cessation therapy.

They are also only a yes or no test, in other words, they can only tell if you are smoking or not smoking but patients do not come in just two flavors. Patients are generally making good efforts or they are making poor efforts and quitting smoking is one of the hardest things that patients have to do clinically. Although we’d like to see patients quit cold turkey, the vast majority do not. The vast majority taper down off cigarettes. For these patients, the cotinine test and the carbon monoxide tests are useless. In contrast, our test, because we can quantify the exact number of cigarettes the patients are smoking, we can transform a ‘yes or no’ to ‘this is improving.’

Most importantly, in a clinical conversation, there are a lot of difficult subjects that are broached. And there are no more difficult subjects in medicine than those of addiction. It’s hard for patients to tell us that they are not doing as well as they would like. And as physicians, sometimes it’s hard for us to hear that our patients aren’t able to tolerate the prescriptions and treatments that we have prescribed. Smoke Signature takes that difficulty out of the equation because it objectively quantifies cigarette consumption and allows the patients to talk about the rest of the issues that are affecting their health and well-being and the pursuit of their goal of healthier living.


Who benefits from the Smoke Signature Assay?

Well the short answer to that is easy. Everyone. I think the shared goal of researchers, clinicians, and patients is to stop smoking. Smoke Signature was developed through funding from the National Institutes of Health exactly for the purpose of smoking cessation.

Researchers are going to be the first to benefit. In order to stop smoking, researchers need to be able to accurately measure smoking. And the use of vaping e-cigarettes has completely upended their ability to use cotinine tests to measure smoking. The smoke signature test completely addresses that problem and allows those same scientists to exactly measure and monitor cigarette consumption using saliva. There is no necessity in drawing blood, there is no necessity of having an awkward conversation about a urine specimen. Just have the patients spit into our tube and voila!


What type of sample is used to obtain the DNA needed for the assay and how is that collected?


The DNA that can be used with smoke signature comes in two forms. The first is blood. Blood is the medical standard. However, for research purposes and eventually telemedicine purposes, blood really is not an option. Thus, in partnership with IBI Scientific, we developed a handy-dandy saliva kit that researchers and eventually clinicians will be able to use to obtain saliva samples for Smoke Signature testing.


Are there distinct advantages to using saliva versus other types of samples, such as blood?

Well, I always tell people, I am a doctor who is very brave when I have the needle. However, I do not like getting poked. I think one of the difficulties in getting patients to come see physicians is the pit in their stomachs that represents the fear that they might get poked. The saliva-based test completely obviates that fear and allows patients to walk forward confidently in their physician’s office. Another one of the biggest advantages of using saliva is the absence of the need for a phlebotomist. The drawing of blood is discomforting to many patients and costs money. In fact, getting a phlebotomist to come to your house to draw blood can cost a hundred or two hundred dollars and potentially exposes you to infectious diseases such as COVID. However, by simply obtaining a saliva kit in the mail, spitting in the tube and returning it to a testing lab, you can completely miss any opportunity to be exposed to COVID, influenza or any other form of infectious disease.


Where can the Smoke Signature Assay and the Saliva Collection Kit be purchased?

The one thing about me is, you will find out is that I am a passionate physician and a fairly decent scientist, but Dr. Philibert does not do manufacturing. We have partnered with IBI Scientific, a trusted supplier of laboratory supplies to thousands of laboratories across the United States to supply both the smoke signature kits and saliva kits to those interested in the assay. It takes us out of the conversation and allows other investigators to use the test independently. One of the good hallmarks of science is that it should work without the scientist. Science is a technique; it is not a personality. When we developed this test in partnership with the National Institutes of Health, we agreed that we would make this test available to researchers across the world without any stipulations so we are very glad that IBI Scientific has agreed to be our supplier of the Smoke Signature Assay for other investigators. I will be happy to work with any and all so that the scourge of smoking is eradicated from the face of the United States.



Thank you to Dr. Rob Philibert for allowing us to interview him regarding these products and his contributions to global smoking cessation efforts. View our Smoke Signature Assay and Saliva Collection Kits to purchase for your scientific research purposes!

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