Barrett's esophagus (BE) is a precancerous condition and the only known precursor to esophageal adenocarcinoma — one of the fastest-growing and deadliest cancers in the United States.
Barrett's esophagus (BE) is a precancerous condition caused by chronic gastroesophageal reflux disease (GERD). Over time, persistent acid exposure damages the normal esophageal lining, replacing it with tissue similar to the intestinal lining — a process called intestinal metaplasia. While Barrett's esophagus itself may not cause symptoms, it significantly increases the risk of developing esophageal adenocarcinoma.
Barrett's esophagus is diagnosed through upper endoscopy with biopsy — the recognized standard protocol. During the procedure, a thin, flexible tube with a camera is guided into the esophagus to visually inspect the lining. If abnormal tissue is observed, tissue samples are collected for pathological analysis. The length of the Barrett's segment is classified to help determine the surveillance and treatment approach.
Treatment options include endoscopic eradication therapy (EET) such as endoscopic mucosal resection (EMR) and ablation techniques including radiofrequency ablation and cryotherapy. Proton pump inhibitors (PPIs) are prescribed to control acid reflux. Surveillance guidelines from the ACG and AGA recommend endoscopy every 3–5 years for non-dysplastic BE, and every 3–6 months for low-grade dysplasia.
In a healthy esophagus, the lining is composed of squamous epithelial cells. With Barrett's esophagus, chronic acid exposure triggers intestinal metaplasia — the normal cells are replaced by columnar cells resembling the intestinal lining. This change is a precursor to dysplasia and potentially adenocarcinoma, making regular monitoring essential.
Key risk factors for Barrett's esophagus include chronic GERD lasting 5+ years, age over 50, male sex, Caucasian ethnicity, obesity (particularly central adiposity), smoking history, and family history of Barrett's or esophageal cancer. If you have multiple risk factors, discuss BE screening with your gastroenterologist.
Introducing BE-SmartTM, a patent protected mass spectrometry-based test. It is intended to detect and quantify early signs of adenocarcinoma in individuals with GERD and Barrett’s esophagus, conditions known to significantly increase the risk of developing esophageal cancer.
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The BE-Smart test represents a significant advancement in the early detection and management of esophageal diseases, with the potential to guide patients towards life-saving treatments and significantly impact public health outcomes.
BE-Smart has the potential to considerably reduce healthcare costs, particularly in terms of the number of endoscopies required by categorizing patients as prone to cancer progression or not.
Developed over six years, The BE-Smart Assay by ProPhase Labs, is a groundbreaking diagnostic tool aimed at revolutionizing the management and treatment of severe esophageal diseases, including GERD, Barrett’s esophagus, and esophageal cancer.
It utilizes patients’ existing biopsy samples to identify biomarkers critical in the pathogenesis of these conditions, thus enabling better patient management strategies
for the estimated 60 million people affected by these diseases in the U.S.
The BE-Smart’s proteomic expression panel is designed to predict the progression of Barrett’s esophagus into cancer and guide new prevention therapies for those at risk.
Target market of 7 million endoscopies per year performed on patients with cases of GERD and/or Barrett’s esophagus. We estimate that we will be reimbursed by insurance at the rate of $1,000-$2,000 per test based on the complexity of our test. Therefore our target market is $7 billion - $14 billion.
This approach addresses the urgent need for advancements in the diagnosis and treatment of esophageal cancer, which is identified as the fastest-rising, deadliest form of cancer in the U.S.
US patent granted safeguarding the BE-Smart technology and extending protection to similar biomarker discovery processes for patent claims limited to esophageal adenocarcinoma.
Recent studies to date have achieved consistently positive preliminary results. BE-Smart has demonstrated a greater than 99% accuracy in distinguishing highly impactful and objective histologic classifications. The latest data is under review by an independent statistics company for potential final presentation to insurance companies for CPT codes and near-term commercialization.
Esophageal cancer ranks as the ninth most prevalent form of cancer and the sixth leading cause of cancer-related mortality worldwide.1
In 2020, it was estimated that there were approximately 604,100 new cases of esophageal cancer and 544,076 fatalities due to this disease globally2.
Estimated Deaths in 2022 in the U.S.3
5-Year Mortality Rate
(2012-2018)3
Estimated New Cases in 2022
Marked the astonishing surge in the annual incidence of EAC in 2017 compared to 19734
Journal of American Medical Association once again reported that GI cancers for the 2nd straight decade are the fastest growing cancer type in America5
Discovering pre-cancerous tissue in early and treatable stages may increase disease survival and decrease cost of care. As high as 40% of esophageal carcinoma is missed or found late leading to more unfavorable diagnosis.
Detection of Barrett’s esophagus typically follows a history of long-standing GERD, with some patients reporting a cessation of heartburn symptoms as Barrett’s develops.
Gastroesophageal Reflux Disease (GERD) occurs when stomach acid repeatedly flows back into the esophagus. Backwash (acid reflux) can irritate the lining of esophagus. Many experience acid reflux from time to time; for some, GERD may trigger a change in the cells lining the lower esophagus causing Barrett’s Esophagus.
Barrett’s Esophagus is a condition in which the esophagus becomes damaged by acid reflux; causes the lining to thicken and become red. Associated with increased risk of developing Esophageal Adenocarcinoma.
Diagnosis involves an endoscopic examination, allowing doctors to visually inspect the esophagus and, if necessary, collect tissue samples for further analysis to measure the progression towards cancer.
1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9807450/
2. https://acsjournals.onlinelibrary.wiley.com/doi/epdf/10.3322/caac.21660?src=getftr
3. https://bit.ly/40ONuqt - Cancer Stat Facts: Esophageal Cancer
4. https://bit.ly/3KGWGr9 - Epidemiology of early esophageal adenocarcinoma
5. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2808381