ProPhase Labs Announces Study Validating BE-Smart Esophageal Cancer Test Accepted by Journal of Clinical Gastroenterology and Hepatology

Core Insights - ProPhase Labs Inc. has achieved a significant milestone with the acceptance of its pivotal clinical study on the BE-Smart™ esophageal cancer test for publication, marking a transition from validation to commercialization [1][2][5] Market Opportunity - The BE-Smart™ assay targets a total addressable market of approximately $7–$14 billion, with around 7 million upper endoscopies performed annually in the U.S. for GERD and Barrett's Esophagus surveillance [2] Clinical Validation - The study provides peer-reviewed clinical evidence supporting BE-Smart, which is an 8-protein, mass spectrometry-based assay developed in collaboration with the Mayo Clinic [3][10] - In a blinded cohort of 100 patients, BE-Smart demonstrated 100% sensitivity in identifying patients who progressed to cancer, with strong predictive accuracy (AUC 0.89–1.0) for near-term disease progression [4][8] Product Features - BE-Smart is designed to deliver objective, molecular risk stratification, allowing gastroenterologists to visualize disease progression through proteomic analysis [9][10] - The assay is compatible with FFPE biopsy tissue and integrates seamlessly with standard pathology workflows, making it suitable for clinical laboratory adoption and scalability [8][10] Strategic Partnerships - ProPhase is advancing regulatory preparations and scaling laboratory efforts in partnership with leading gastroenterology practices, while also pursuing collaborations with key opinion leaders and health-system partners [2][5] Clinical Impact - The BE-Smart assay aims to improve clinical workflow and cost efficiency by escalating care for high-risk patients and avoiding unnecessary procedures for low-risk cases [15]