A real-world analysis of nearly 12,000 patients found that esophageal cell collection was successful in 95% of cases, with procedures taking less than two minutes on average.
A study of nearly 12,000 patients found that a nonendoscopic device used to collect samples for esophageal precancer testing achieved a 95% collection success rate, with procedures taking less than two minutes on average.
The study, published in Diagnostics, evaluated Lucid Diagnostics’ EsoCheck Esophageal Cell Collection Device, which collects samples for the company’s EsoGuard DNA test. Researchers found that sample collection was generally well tolerated and produced consistent results across operators, including newly trained personnel.
“These findings provide compelling real-world evidence supporting the feasibility of large-scale implementation of EsoGuard testing,” says Lishan Aklog, MD, Lucid’s chairman and CEO, in a release. “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.”
Study Results
The analysis included 11,991 patients with clinical risk factors who underwent EsoGuard testing on samples collected with EsoCheck between January 2023 and June 2024. Key findings include:
- Cell collection was successful in 95% of patients.
- 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, and only 0.2% rated discomfort as high. Ninety-six percent said they would recommend the test to others, and 95% said they would undergo it again if clinically indicated.
“We are very encouraged by the real-world performance of EsoGuard and EsoCheck in this large cohort of patients referred for esophageal precancer testing,” says Victoria T. Lee, MD, Lucid’s chief medical officer, in a release. “The high cell collection success rate across operators, including among newly trained personnel, high patient satisfaction scores, and short average procedure time strongly support large-scale implementation to broadly expand access to esophageal precancer testing in at-risk patients.”
Lucid, a subsidiary of PAVmed, focuses on the millions of patients with gastroesophageal reflux disease, also known as chronic heartburn, who are at risk of developing esophageal precancer and cancer. EsoGuard is performed on samples collected in a brief, noninvasive office procedure using EsoCheck.
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