Novel Esophageal Cancer Test Could Reduce Unnecessary Endoscopies

Barrett's Esophagus is a condition in which the flat pink lining of the esophagus - the swallowing tube that connects the mouth to the stomach - becomes damaged due to acid reflux, causing it to thicken and become red. People with Barrett's Esophagus are more likely to develop a type of cancer called esophageal adenocarcinoma. Esophageal cancer is a highly lethal form of cancer, with an overall five-year survival rate of less than 20%. As a result, millions of endoscopies are performed annually on patients with Barrett's Esophagus before it advances to esophageal cancer. However, current diagnostic protocols lack interobserver agreement and descriptive molecular assessment tools to help determine appropriate screening for precancerous esophageal diseases and the most effective therapeutic options. Now, a mass spectrometry-based test, once clinically validated, could diagnose pre-cancerous cells years earlier than current standard diagnostic protocols for esophageal cancer, as well as reduce unnecessary endoscopies.

ProPhase Labs, Inc.’s (Garden City, NY, USA) BE-Smart test for the early detection of esophageal cancer is designed to provide healthcare providers and patients with data to make informed decisions about treatment. It can help assess whether patients not viewed to be at risk for esophageal cancer should continue to be monitored or provide early treatment to patients who might otherwise have been undiagnosed before esophageal cells become cancerous. By detecting esophageal cancer in its early stages before cells become cancerous, the test could make it possible to initiate potentially lifesaving treatments such as ablation procedures. Widespread adoption of the diagnostic test would reduce the number of unnecessary endoscopies and provide peace of mind to those suffering from Barrett's syndrome who are at a higher risk of developing esophageal cancer.

In tests on over 200 human samples, the BE-Smart test has demonstrated sensitivity and specificity of greater than 99% in detecting protein expressions in cells that have a high risk of becoming cancerous. The initial data demonstrates accuracy and reproducibility as well as identification of potential biomarkers for therapeutic drug discovery to treat esophageal cancer. As a mass spectrometry-based test, the BE-Smart assay that, once clinically validated, could provide a fully quantitative analysis of the markers and other proteins indicative of disease progression from formalin-fixed, paraffin-embedded forceps biopsies. The test also has the potential to demonstrate the predictability of carcinogenesis, as traditional oncogenes have failed to yield consistent prognostic results.

“The future for this diagnostic test is very exciting and could save countless lives by diagnosing pre-cancerous cells years earlier than current standard diagnostic protocols for esophageal cancer,” said Ted Karkus, CEO of ProPhase Labs. “Once we complete our testing cycle, we will pursue the adoption of the BE-Smart diagnostic test as a standard health care test that could be utilized in conjunction with every endoscopy to accurately predict the risk of esophageal cancer.”

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ProPhase Labs, Inc.