ProPhase Labs' BE-Smart Test Gains Recognition in Clinical Gastroenterology
The study acceptance signals a major step towards commercialization and revenue potential.
UNIONDALE, NY — ProPhase Labs Inc. (NASDAQ: PRPH), a forward-thinking biotech and consumer products company, has exciting news! The company has announced that its pivotal clinical study, led by the esteemed Hartley et al., validating the BE-Smart™ esophageal cancer test, now holds a place in the Clinical Gastroenterology and Hepatology journal, an official publication of the American Gastroenterological Association.
This breakthrough represents a significant moment as ProPhase transitions from validating its innovative test to the commercialization phase of BE-Smart. With nearly 7 million upper endoscopies conducted annually in the country for conditions like GERD and Barrett’s Esophagus surveillance, BE-Smart is poised to tap into a considerable market, estimated between $7 billion and $14 billion. The company is diligently advancing its regulatory preparations and expanding laboratory capabilities to support clinical testing alongside top gastroenterology practices. Moreover, ProPhase aims to establish partnerships with key figures and health systems to seamlessly integrate BE-Smart into standard patient care processes, facilitating the test request through conventional pathology channels, with commercialization efforts set to commence in 2026.
The published study, entitled Assessing Risk of Progression in Barrett’s Esophagus Using a Mass-Spectrometry-Based Proteomic Panel, showcases robust, peer-reviewed clinical evidence that supports BE-Smart, an 8-protein mass spectrometry test designed with collaborative effort from ProPhase Labs and the prestigious Mayo Clinic. This innovative assay is focused on determining the risk of progression from Barrett’s Esophagus to high-grade dysplasia or esophageal adenocarcinoma (EAC).
With a unique approach, BE-Smart achieved an impressive 100% sensitivity in identifying patients who subsequently progressed to cancer. It also established a noteworthy correlation linking predicted molecular risk with time to progression. Independent testing reaffirmed its efficacy, showing strong results comparable to leading molecular assays, especially advantageous in identifying patients likely to experience progression within three years. These accomplishments surpass initial performance expectations and affirm BE-Smart’s role as a vital tool in early cancer screening and prevention.
As Ted Karkus, CEO of ProPhase Labs, noted: “This acceptance into a prominent gastroenterology journal is monumental for both ProPhase and the management of Barrett’s Esophagus. We are advancing a legacy of molecular screening in esophageal diseases with BE-Smart, offering a refined, tissue-sparing, and highly scalable solution demanded by the gastroenterology community. Our collaboration with Mayo Clinic furnishes a tool that is not only precise and highly sensitive but also reduces the need for additional tissue sampling, making it advantageous for physicians and patients alike. We are confident that BE-Smart represents the future of esophageal disease surveillance and management.”
Key Findings Highlighted
- Perfect sensitivity demonstrated in detecting patients who later developed cancer.
- High predictive accuracy showcasing AUC values up to 1.0 in testing cohorts for imminent disease progression.
- Clear association observed between quantitative proteomic scores and the timeline for progression.
- Exceptional performance noted in cases with non-dysplastic and “indefinite for dysplasia” histologies, where traditional histology assessment falls short.
- Seamlessly integrates with routine FFPE biopsy tissue, complying with standard pathology workflows.
- Designed for high-throughput capability and multiplexing to facilitate scaling in clinical laboratory settings.
The Importance of BE-Smart
Barrett’s Esophagus affects a significant portion of the adult population; however, most patients do not progress to cancer, making management challenging for gastroenterologists. Traditional surveillance methods involve subjective histological assessments and frequent endoscopic procedures which could be invasive and unwarranted.
BE-Smart addresses this vital diagnostic gap. By providing objective molecular risk assessments, it empowers gastroenterologists to:
- Intensify care for individuals at heightened risk.
- Minimize unnecessary interventions and costs for low-risk cases.
- Enhance clinical workflows, improving overall efficiency.
Dr. Joe Abdo, Scientific Advisor at ProPhase Labs, affirmed, “This is revolutionary for gastroenterologists. BE-Smart allows them to visualize the proteomic changes associated with disease advancement, showing real-time protein expression relevant to cell growth and immune reactions directly from standard biopsy tissues. BE-Smart stands as an essential tool for early esophageal cancer detection, promising immediate, actionable, and long-overdue improvements to patient care.”
Understanding BE-Smart
BE-Smart is a sophisticated multiplex proteomic assay crafted with advanced quantitative mass spectrometry techniques from meticulously collected esophageal biopsy specimens. This assay evaluates the expression levels of eight proteins associated with the risk of disease progression in Barrett’s Esophagus. It is entirely compatible with conventional FFPE tissues. This publication marks a milestone from ProPhase Labs’ pioneering STLA (Stratify-to-Limit-Advance) precision oncology pipeline, indicating promising advancements in cancer detection methodologies.
About ProPhase Labs Inc.
ProPhase Labs Inc. (NASDAQ: PRPH) is at the forefront of biotechnology, genomics, and consumer wellness products. Our vision centers on creating a healthier future through groundbreaking innovation and meaningful insights. We're transforming healthcare with our industry-leading Whole Genome Sequencing services, innovative diagnostic tests like our early detection method for esophageal cancer, and a robust marketing platform for cutting-edge OTC dietary supplements. We devote ourselves to manufacturing and commercializing health solutions that empower individuals to lead healthy lives. Committed to excellence, smart diversification, and a comprehensive omnichannel strategy, ProPhase Labs showcases substantial growth potential with its synergistic subsidiaries.
Media Relations and Investor Contacts:
ProPhase Labs, Inc.
Media: investorrelations@prophaselabs.com
Retail Investor Contact:
Renmark Financial Communications
John Boidman: jboidman@renmarkfinancial.com
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Frequently Asked Questions
What is the BE-Smart test?
BE-Smart is a novel multiplex proteomic assay developed by ProPhase Labs to assess the risk of progression from Barrett's Esophagus to esophageal cancer.
How was the BE-Smart test validated?
The BE-Smart test was validated through a clinical study showing 100% sensitivity in identifying patients who progressed to cancer.
When will BE-Smart be commercially available?
ProPhase Labs plans to roll out the BE-Smart test in a phased approach starting in 2026.
Why is BE-Smart important for patient care?
BE-Smart provides objective risk assessments, helping clinicians make informed decisions, reduce unnecessary procedures, and improve efficiency in patient care.
What does ProPhase Labs specialize in?
ProPhase Labs specializes in biotechnology, genomics, and consumer health products, focusing on innovative solutions and precision oncology.
