Nonendoscopic Methylation Assay Enables Rapid Barrett’s Esophagus Screening

Millions of patients with gastroesophageal reflux disease (GERD), also known as chronic heartburn, are at risk of developing esophageal precancer and cancer. Nonendoscopic sample collection may support evaluation of these patients, but its speed, tolerability, and consistency across operators require assessment. Addressing these practical questions, a newly published, large-scale real-world study evaluated office-based esophageal cell collection completed in under two minutes, including procedures performed by newly trained personnel.

The evaluation involved Lucid Diagnostics’s EsoGuard Esophageal DNA Test and EsoCheck Esophageal Cell Collection Device. EsoGuard was used for nonendoscopic screening for Barrett’s esophagus as a DNA methylation-based assay. Samples were collected with EsoCheck during a brief, noninvasive office procedure. The manuscript, titled “Non-Endoscopic Screening for Barrett's Esophagus Using a DNA Methylation-Based Assay: Real-World Experience in 11,991 Patients,” was published in the journal Diagnostics.

The study included 11,991 patients with clinical risk factors who underwent EsoGuard testing on samples collected with EsoCheck between January 2023 and June 2024. Cell collection was successful in 95% of patients, and average collection time was less than two minutes. No device-related adverse events were reported. In a post-procedure survey, 82% of patients reported very low discomfort, 0.2% rated discomfort as high, 96% said they would recommend the test to others, and 95% said they would undergo it again if clinically indicated.

Lucid describes the study as the largest peer-reviewed study of nonendoscopic esophageal precancer testing to date. The findings emphasized the efficiency and scalability of EsoCheck cell collection across operators in a real-world setting. Lucid also describes EsoGuard and EsoCheck as commercially available tools designed with the goal of early detection of esophageal precancer in at-risk patients.

“These findings provide compelling real-world evidence supporting the feasibility of large-scale implementation of EsoGuard testing. With EsoGuard now fully reimbursed by Medicare nationwide, efficient and scalable clinical implementation will be critical as we accelerate commercialization across diverse clinical settings in the coming months,” said Lishan Aklog, M.D., Lucid’s Chairman and Chief Executive Officer.

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