Heavy alcohol use is common and presents a major social/economic challenge. Although chronic use of small amounts of alcohol is not always harmful, heavier use (>2 drinks/day) is generally harmful and frequently leads to alcoholism, or as it is termed in ICD-10, Alcohol Use Disorder (AUD). AUD affects ~25% of the U.S. population and causes over $200 billion/yr of economic damage. In addition, alcohol use in critical situations presents potentially grave consequences, whose impacts cannot be measured. These adverse outcomes are avoidable if heavy alcohol consumption is spotted early; however, current screening methods for chronic alcohol use capture alcohol usage only in the hours prior to testing or rely on insensitive, non-specific protein assays. A next-generation method that could more reliably identify heavy alcohol consumption and monitor abstinence would be of great interest to a large number of companies and groups, including medical, governmental, security and transportation agencies. Developing, validating, and commercializing such a next- generation technology is Behavioral Diagnostic's overall goal. In a very successful R43 application using relatively healthy alcoholics, we recently demonstrated that DNA methylation assessment can robustly identify heavy consumers of alcohol. In this Phase II application, we plan on completing the initial commercialization of this disruptive technology by creating and testing a select group of quantitative PCR (qPCR) markers in an ethnically and medically diverse group of subjects, then selecting the most predictive markers of heavy alcohol consumption for inclusion in first generation commercial array. Specifically, we will construct a set of 20 qPCR assays for the most predictive loci. Simultaneously, we will collect 250 subjects admitted for the treatment of alcoholism and 250 controls. We will then test these qPCR markers using these DNA from these 500 subjects. Then we will extend these findings using DNA from 2000 other subjects already characterized for alcohol intake. The most predictive markers will be incorporated into commercial array produced in collaboration with Integrated DNA Technologies (IDT), the largest world's commercial manufacturer of oligonucleotide products. Behavioral Diagnostics is ideally poised to develop and commercialize this disruptive technology. Our scientific team is the international leader in substance use epigenetics. The Phase II team is led by Dr. Rob Philibert, the Chief Scientific Officer, who is an internationally known expert in substance use epigenetics. The CFO and CEO are experienced corporate executives. The board will include leading corporate and academic figures. The intellectual property is already controlled by the company. The array development pathway will be GLP/CLIA compliant and leverage strategic alliances with internationally known companies. A strong plan for market entry has been devised and the product will complement a recently patented, highly sensitive and specific test for the quantification of smoking.
The purpose of this application is to produce a set of quantitative PCR assays that can be used to detect heavy chronic alcohol consumption in whole blood. The resulting kit will find considerable utility commercially in the diagnosis and treatment of alcoholism.
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|Philibert, Robert; Glatt, Stephen J (2017) Optimizing the chances of success in the search for epigenetic biomarkers: Embracing genetic variation. Am J Med Genet B Neuropsychiatr Genet 174:589-594|