Achieving FDA Approval & Commercial Readiness for Beacon-AUD: A Digital Diagnostic Medical Device for Alcohol Use Disorder

Beam Diagnostics, Inc., Roanoke VA

Investigators

Abstract

PROJECT SUMMARY Excessive alcohol use and alcohol use disorder (AUD) contribute to numerous and severe health conditions, including cancers, liver, and heart disease, and exacerbate existing conditions including diabetes and mental illness. Early detection and diagnosis of AUD is critical to optimize patient outcomes. Routine assessment for AUD, however, is simply under-performed. BEAM seeks to establish the standard for behavioral health diagnosis and empower providers to advance proactive, patient-centered healthcare. In alignment with this mission, our first diagnostic module, Beacon-AUD, mitigates the stigma, time constraints, and underperformance of the assessment and diagnosis of AUD within clinical settings. Beacon-AUD can be administered in less than two minutes, providing easy-to-understand results integrated directly with the provider's electronic medical record (EMR). This innovative approach, and the successful completion of this proposal, will set Beacon-AUD as the first FDA-approved software as a medical device dedicated to AUD diagnosis. Our funded Phase II STTR (R42 AA026794) for Beacon-AUD resulted in highly successful product and implementation optimization, EMR integration, and initial norming in a crowdsourced dataset. However, Phase II also identified four additional objectives that must be obtained for full commercialization. Aim 1 will be dedicated to a multi-site clinical study following feedback from the FDA on our pre-De Novo submission. In Aim 2, we will respond to physician-user feedback collected in Phase II by convening an Expert Panel to develop consensus on AUD treatment options to be delivered by Beacon-AUD following clinical diagnosis. Aim 3 will prepare all regulatory submission documents in accordance with the requirements of the FDA and in coordination with an experienced regulatory consultant. Finally, Aim 4 will initiate validation of Beacon-AUD’s economic value proposition to payors using Health Economics and Outcomes Research (HEOR). At the conclusion of this CRP project, BEAM will have completed the final steps for a market-ready Beacon-AUD as the first FDA-regulated software as a medical device for rapid, valid, non-stigmatizing assessment of AUD. By addressing the existing barriers to diagnosis, providing evidence-based clinical recommendations, submitting for FDA approval, and gathering a deep understanding of market forces acting on diagnostic software, we envision Beacon-AUD as substantially improving the identification and treatment of AUD in routine practice and being ready for full market adoption.