ProPhase Labs(US:PRPH) Globenewswire·2025-10-29 12:30Core Insights - ProPhase Labs has published a peer-reviewed study demonstrating the effectiveness of its BE-Smart assay for identifying patients at risk of progressing from Barrett's Esophagus to esophageal adenocarcinoma, achieving 100% sensitivity in detecting such patients [1][5] - The BE-Smart assay is positioned as a next-generation molecular screening tool, ready for clinical adoption and reimbursement discussions, with early access programs expected to begin in early 2026 [2][6] Group 1: Study Findings - The BE-Smart assay utilizes an 8-protein mass-spectrometry-based approach, requiring significantly less tissue than traditional assays, and is compatible with various biopsy methods [3][4] - The assay demonstrated strong predictive performance with an overall area under the curve (AUC) of 0.75, and an AUC of 0.89 in an independent test cohort, indicating high diagnostic accuracy [5] - A hazard ratio of 66.1 indicates that patients classified as high-risk by BE-Smart are approximately 66 times more likely to progress to esophageal cancer compared to low-risk patients [5] Group 2: Clinical Implications - The greatest clinical benefit of BE-Smart is observed in patients with non-dysplastic Barrett's Esophagus, providing clear molecular risk stratification where traditional histopathology offers limited insight [5] - The assay aims to enable earlier identification of at-risk patients, potentially improving outcomes through precision screening, addressing the challenge of late-stage diagnosis in esophageal cancer [7] Group 3: Company Strategy - ProPhase Labs is advancing BE-Smart towards broad commercialization, focusing on laboratory partnerships, payer engagement, and expanded real-world studies in collaboration with gastroenterology networks [6] - The company emphasizes its commitment to innovation in healthcare, with BE-Smart being part of its precision oncology pipeline [8][9]