Lucid Diagnostics' EsoGuard Esophageal DNA Test has shown promising results in a recent clinical utility study, demonstrating its effectiveness as a triage tool for detecting Barrett's Esophagus (BE). The study, titled "Real-world Clinical Utility of a Methylated DNA Biomarker Assay on Samples Collected with a Swallowable Capsule-balloon for Detection of Barrett's Esophagus (BE)," has been accepted for publication in the peer-reviewed journal Medicina.
The CLinical Utility of EsoGuard (CLUE) study, a prospective, multicenter trial, enrolled patients meeting gastroenterology society guideline criteria for esophageal precancer screening from eight clinical centers. A total of 502 patients contributed to the clinical utility endpoints. The study assessed the impact of EsoGuard on physician decision-making and patient compliance with recommended follow-up.
High Patient Compliance and Provider Impact
The study demonstrated that 100% of EsoGuard-positive patients were referred for confirmatory upper endoscopy (EGD), while over 99% of EsoGuard-negative patients were not referred. Among patients with positive EsoGuard results, compliance with follow-up EGD was 85%, more than double the patient compliance rate with screening EGD referral in the published literature. This high compliance rate suggests that patients are more likely to adhere to recommended screening when using the non-invasive EsoGuard test.
"The final results from the CLUE study strongly support the clinical utility of EsoGuard as an effective triage tool for esophageal precancer testing of at-risk patients," said Victoria T. Lee, M.D., Lucid's Chief Medical Officer. "EsoGuard enables physicians to effectively triage patients at increased risk for esophageal precancer to confirmatory upper endoscopy. Once again, physicians consistently utilized our non-invasive EsoGuard test to appropriately refer patients to endoscopy, allowing the vast majority of patients to avoid this more expensive and invasive procedure. Patients, in turn, showed an exceptionally high level of compliance with their physician's referral to EGD."
About EsoGuard and EsoCheck
Lucid Diagnostics markets the EsoGuard Esophageal DNA Test and the EsoCheck Esophageal Cell Collection Device. EsoCheck is a non-invasive device used to collect esophageal cells in a brief office procedure. EsoGuard then analyzes these cells for methylated DNA biomarkers associated with Barrett's Esophagus.
Barrett's Esophagus is a precancerous condition that develops in the lining of the esophagus as a result of chronic acid reflux. Patients with GERD are at increased risk of developing BE, which can progress to esophageal adenocarcinoma, a deadly form of cancer. Early detection of BE is crucial for preventing esophageal cancer.
The study authors concluded that "EsoCheck is easy to implement for non-endoscopic in-office esophageal cell sampling, and the EsoGuard methylated DNA assay is effective in guiding provider decision-making…Patients with positive test results also demonstrate high compliance with recommended follow-up endoscopy."
