Prophase Labs Announces Publication Of Peer-Reviewed Study In Clinical And Translational Gastroenterology Conducted With The Mayo Clinic, Showing 100% Sensitivity And Strong Predictive Accuracy For Progression To Esophageal Cancer

Peer-Reviewed Study Conducted in Collaboration with Mayo Clinic Demonstrates 100% Sensitivity and Strong Predictive Power for Esophageal Cancer Progression

Early Access Programs and Physician Onboarding Initiatives Expected to Begin in Early 2026

 ProPhase Labs, Inc. (NASDAQ:PRPH) today announced that its study, "Assessing Risk of Progression in Barrett's Esophagus Using a Mass-Spectrometry-Based Proteomic Panel," has been published online in Clinical and Translational Gastroenterology, the official journal of the American College of Gastroenterology (ACG).

The publication presents full clinical validation data supporting BE-Smart, an 8-protein, mass-spectrometry-based proteomic assay developed for risk stratification of patients with Barrett's Esophagus (BE). Conducted in collaboration with the Mayo Clinic, the study demonstrates that BE-Smart provides a highly accurate, molecularly driven method for identifying BE patients most likely to progress to high-grade dysplasia or esophageal adenocarcinoma. These findings position BE-Smart as a next-generation molecular screening tool ready for broad clinical adoption and reimbursement discussions.

Key findings include:

• 100% sensitivity for identifying patients who later developed esophageal adenocarcinoma, indicating that BE-Smart successfully detected all patients who ultimately progressed to esophageal cancer, with no false negatives observed.
• BE-Smart demonstrated strong predictive performance across multiple analyses, with an overall area under the curve (AUC) of 0.75, indicating solid diagnostic accuracy in distinguishing progressors from non-progressors. In the independent test cohort, the model achieved an AUC of 0.89, showing excellent reproducibility and generalizability. Most notably, for patients who progressed within three years, the test reached an AUC of 1.0, meaning it perfectly identified every individual who later developed advanced disease.
• Hazard ratio of 66.1 (p = 0.00012), meaning that patients classified as high-risk by BE-Smart were approximately 66 times more likely to progress to esophageal cancer than low-risk patients, demonstrating exceptionally strong predictive power and correlation with real-world clinical outcomes.
• The greatest clinical benefit was observed among patients with non-dysplastic Barrett's Esophagus, individuals who show no histologic evidence of dysplasia yet still face unpredictable cancer risk. In this population, traditional histopathology offers limited prognostic insight, often leading to either overtreatment or delayed intervention. BE-Smart provided clear molecular risk stratification in these patients, identifying those silently trending toward disease progression while reassuring others at genuinely low risk.