The mass spectrometry-based assay achieved 100% sensitivity in detecting patients who later progressed to cancer in a blinded cohort study.
A clinical study validating ProPhase Labs’ BE-Smart esophageal cancer test has been accepted for publication in Clinical Gastroenterology and Hepatology, the official journal of the American Gastroenterological Association.
The study, titled “Assessing Risk of Progression in Barrett’s Esophagus Using a Mass-Spectrometry-Based Proteomic Panel,” presents clinical evidence supporting the eight-protein, mass spectrometry-based assay that stratifies the risk of progression from Barrett’s Esophagus to high-grade dysplasia or esophageal adenocarcinoma.
In a blinded cohort of 100 patients, BE-Smart achieved 100% sensitivity in identifying those who later progressed to cancer and demonstrated a correlation between predicted molecular risk and time to progression. In independent testing, the model showed discriminative performance with an area under the curve of 0.89–1.0 in test cohorts, with particular effectiveness for identifying patients likely to progress within three years.
The assay was developed through a collaborative research effort between ProPhase Labs and the Mayo Clinic. With approximately 7 million upper endoscopies performed annually in the US for GERD and Barrett’s Esophagus surveillance, the company estimates a total addressable market of roughly $7 to $14 billion.
“Acceptance of this work by a top-tier gastroenterology journal marks an important milestone for ProPhase and for the clinical management of Barrett’s Esophagus,” says Ted Karkus, CEO of ProPhase Labs, in a release. “With BE-Smart, we are advancing that legacy with a more streamlined, tissue-sparing, and highly scalable solution.”
Key Performance Characteristics
The study findings showed the assay demonstrated strongest performance in non-dysplastic and “indefinite for dysplasia” cases, where histology is least reliable. The test is compatible with formalin-fixed paraffin-embedded biopsy tissue and integrates with standard pathology workflows.
Additional key findings include:
High predictive accuracy for near-term disease progression
Strong association between quantitative proteomic scores and time-to-progression
High-throughput and multiplex design suitable for clinical laboratory adoption
Barrett’s Esophagus affects millions of adults in the US, yet only a small percentage will develop cancer. Current surveillance strategies rely on subjective histologic grading and frequent endoscopies.
“BE-Smart allows clinicians to visualize the proteomic hallmarks of disease progression, showing real-time expression of proteins linked to cellular proliferation and immune signaling directly within standard biopsy tissue,” says Dr Joe Abdo, scientific advisor at ProPhase Labs, in a release.
Commercial Rollout Plans
ProPhase is advancing regulatory preparations and scaling laboratory efforts to support clinical testing in partnership with gastroenterology practices. The company is pursuing collaborations with key opinion leaders and health-system partners to integrate BE-Smart into patient-care workflows and clinical decision-making.
These efforts will enable physicians to order the test through standard pathology channels, with a phased rollout planned to begin in 2026.
The molecular risk stratification approach is designed to help gastroenterologists escalate care for patients at highest risk while avoiding unnecessary procedures in low-risk cases.
ID 99461249 © Stockbakery | Dreamstime.com
