BEHAVIORAL DIAGNOSTICS, INC. — Department of Health and Human Services SBIR Phase I: 44

Description

DESCRIPTION provided by applicant Smoking is the most common preventable cause of morbidity and mortality in the United States For of adult smokers this addiction began in adolescence Effective interventions to block the escalation of this initial smoking in adolescents exist However the implementation and effectiveness of these interventions are hindered by the inability of current biomarkers to detect periodic use of cigarettes This substantial problem has recently made substantially worse by the introduction of e cigarettes whose active ingredient nicotine is also metabolized to cotinine As result clinicians cannot determine which adolescents are smoking nor can scientists reliably determine whether e cigarette usage is leading to increased rates of adolescent smoking Recently using a blood based approach Behavioral Diagnostic Inc BDI has developed a epigenetic biomarker referred to as Smoke Signature tm that can sensitively and specifically detect cigarette smoking consumption even in the face of e cigarette use in adults This patented biomarker assesses the methylation level at a CpG residue in the aryl hydrocarbon receptor referred to as cg to determine smoking status The robust sensitivity and specificity of this response of this locus to smoking has been demonstrated in over publications by ourselves and others using tens of thousands of samples However since almost all the previous studies have been performed using DNA isolated from blood and the exact shape of the dose response curve in saliva DNA is not known we are unable to push forward with our efforts to develop a saliva based kit that could be used scientifically to evaluate the effects of e cigarettes and clinically to screen adolescents for behavioral intervention and monitor their response to treatment In Phase I of this Fast Track application we will take advantage of our already developed quantitative PCR qPCR assays data showing that cg methylation in blood and saliva is highly correlated and our already tested saliva kit ingredients to confirm the feasibility of our salia based approach and the equivalence of our saliva DNA kits In Phase II we will determine the sensitivity and specificity of our method for detecting smoking using a two qPCR marker set that includes Smoke Signature and a second marker that compensates for the cellular heterogeneity of saliva Our plan is highly feasible because the expertise of BDIandapos s expertise in epigenetics ou possession of intellectual property rights and our strong team of commercial collaborators that includes established companies to manufacture and co market the products IBI Scientific and IDT It is innovative because the techniques are state of the art and quantitative epigenetic tests are new to the market As a direct result of this research we will produce a kit suitable for researchers interested in smoking and the effects of e cigarettes on the rate of smoking while gaining valuable data that can be used in a future FDA application PUBLIC HEALTH RELEVANCE The purpose of this application is to foster the development of DNA methylation as a tool for the detection of current smoking status and total smoke exposure in adolescents If successful this application may lead to more successful prevention interventions and will create a new product of significant interest to pediatricians prevention specialists and large Accountable Care Organizations ACO