BEHAVIORAL DIAGNOSTICS, INC. — Department of Health and Human Services SBIR Phase I: 450

Description

Imagine a world where alcoholism can be assessed and monitored in the same way that we diagnose and monitor diabetes with a Hemoglobin A cHbA cIn a recent Phase II projectwhose subject collection has closedBehavioral Diagnostics has taken the first step to that better world by developing a droplet digital PCRddPCRpanel that is capable of identifying heavy alcohol consumption with an Receiver Operator CharacteristicROCarea under the curveAUCof andgtThis panelwhich uses the DNA from only one drop of bloodis already in initial commercial introductionIn completion to a pledge that we made when we accepted funding for the above projectwe now propose to identify and develop a ddPCR marker panel for sensitively and specifically assessing alcohol abstinenceWhen completedthis tool could have substantial impact on clinical treatmentSpecificallyan index of these ddPCR markers could be used to precisely monitor patients undergoing outpatient alcohol therapy for compliance with treatment potentially freeing up more intensiveoften inpatient treatment resources for those patients who are failing outpatient treatmentTo accomplish this taskwe propose to extend our priorstudies of abstinence induced methylation changes with an additional genome wide methylation assessment of DNA fromheavily drinking subjects as they enterTand exitTfromday residential therapyWe will meta analyze those data to identify the CpG loci whose change in methylation is most highly associated with alcohol abstinenceWe will then construct ddPCR methylation assays for a subset of these locivalidate assay performance using the Illumina array dataand then test their performance in an independent test set ofsubjects with both Tand TdataThis project is highly feasible because all of the biomaterial and data have been collectedThe team is well prepared and has a published track record with this type of approachDrPhilibert is the CEO of Behavioral Diagnostics and an internationally known expert in both epigenetics and ddPCRHe is assisted by DrMeesha Doganan expert in big data analysesDrJeff Longa well known biostatisticiana bioethicistDrCheryl Erwin and DrJohn Mendelsona well known addiction specialistIt is innovative because these NextGen approaches have not yet been clinically implemented but yet are desperately neededFinallythe environment is excellentBehavioral Diagnostics is established company with protective IPAs a direct resultwe will develop an assay for loci whose change in methylation status is most predictive of alcohol cessationIn Phase IIwe will further translate this into a highly sensitive tool for guiding clinical treatment and improving treatment of alcohol cessation Alcoholism is one of the leading causes of death and disability in the United StatesSadlythere is a paucity of biomarkers that can guide treatmentThis project will generate a panel of PCR assays that can quantify the degree of abstinence in patients undergoing alcohol treatment using the DNA from a single drop of blood