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

Description

Heavy alcohol use is commonyet avoidable cause of deathdisability and human sufferingThese adverse outcomes are potentially avoidable if heavy alcohol use is spotted earlyHowevercurrent screening methods for chronic alcohol consumption capture alcohol usage only in the hours prior to testing or rely on insensitivenon specific protein assaysIn a recent highly successful Phase II projectusing DNA from whole bloodwe demonstrated that a combination of just two methylation sensitive droplet digital PCRMSddPCRassays could quite accurately identify subjects with recent heavy alcohol consumptionSince thenwe have continued to advance those findings and have developed additionaleven more powerful MSddPCR assays and refined our processes to only require the DNA found in a single drop of bloodIn conjunction with our ethics and marketing teamwe are now in the process of rolling this product nationwideHowevera significant barrier to a more universal implementation of this disruptive technology is the requirement for bloodConceivablya test that could use the DNA from saliva could circumvent patient concerns about the discomfort of a needle or lancet stickIn additionit would enable both non medically oriented alcohol treatment programs and telemedicine oriented treatment programs to more easily assess client response to treatmentThis will be particularly critical for treatment of alcoholism in the elderlywho are often unable or unwilling to travel to alcohol treatment facilitiesIn this Phase I proposalwe intend to take the next steps to the creation of a saliva DNA screening test for heavy alcohol consumptionAlreadywe have collected and prepared saliva DNA onsubjects recently admitted to alcohol treatment andagegender and ethnicity matched controlsIn additionwe have also developed an MSddPCR assay that can adjust for cellular heterogeneity in the saliva DNAIn this applicationwe will use these resources to whether MSddPCR assessments of saliva DNA can also be used to detect heavy alcohol consumptionSpecificallyin Aimwe will determine methylation status atCpG loci with high predictive power for detecting alcohol consumption and one locus whose information content can be used to correct for cellular admixture in salivaThenin Aimwe will conduct a series of quality assessment of the saliva DNAFinallyin Aimwe will analyze the data from ourhighly predictive locicorrecting when necessary for cellular admixtureto determine an algorithm capable of predicting heavy alcohol use statusIn additionwe will analyze the quality control measures to identify those saliva DNA samples which give unreliableAs a result of this projectwe will produce a set of MSddPCR assays and a quality control metric for a rigorous multisite Phase II test of thisbloodlessNextGen product Narrative Current diagnostic approaches for the assessment of heavy alcohol use normally use bloodHowevermany patients do not like to have their blood drawn or are cared for in a healthcare setting in which blood cannot be obtainedIn this projectwe will adapt our recently discovered DNA methylation based techniques to see if they can use saliva DNA instead of whole blood DNA