Lucid Diagnostics Inc. announced findings from two clinical studies of its EsoGuard®? Esophageal DNA Test and EsoCheck®? Cell Collection Device, presented at this week's Digestive Disease Week (DDW) 2023 conference--the world's premier meeting for digestive disease professionals.

Acceptability of Non-endoscopic Screening for Barrett's Esophagus (BE) Among Veterans Eligible for Screening: Sixty-nine patients at the Louis Stokes Cleveland VA Medical Center underwent non-endoscopic esophageal precancer biomarker testing followed by confirmatory upper endoscopy as part of a prospective investigator initiated clinical trial. All but one patient (99%) underwent successful noninvasive esophageal cell sampling using the EsoCheck device. EsoGuard sensitivity was 100% and all seven patients with endoscopically documented esophageal precancer or cancer were detected by EsoGuard.

Six of the seven had early precancerous non-dysplastic BE—four with short segment BE and two with long segment BE. The seventh patient had a previously silent Stage III esophageal cancer (adenocarcinoma) detected and treated with chemotherapy and radiation. The estimated negative predictive value (NPV), and positive predictive value (PPV), based on the expected prevalence in a screening population, were 100%and 37%, respectively, and consistent with generally accepted targets for a widespread screening tool.

Real World Data Using EsoCheck, a Non-endoscopic Esophageal Cell Collection Device for Early Detection of Barrett Esophagus and Esophageal Adenocarcinoma: Data from a real-world cohort of 1,483 patients who underwent EsoCheck esophageal cell sampling by trained nurse practitioners were retrospectively analyzed. The findings were consistent with a previous analysis in a smaller cohort presented last year at the American Association for Cancer Research (AACR) conference. Non-invasive, non-endoscopic, in-office EsoCheck cell sampling was successfully performed in 98% of patients, in less than three minutes on average.

It was broadly well-tolerated with 86% of patients reporting no, or no more than a mild gag reflex. Upgrades to the laboratory's DNA extraction procedure, implemented since the last report, resulted in substantial improvements in DNA yield, with the proportion of patients with insufficient DNA falling from 6% to 2%.