EsoGuard® continues to demonstrate excellent esophageal precancer and cancer detection performance, including in most prevalent and challenging precancer subgroup—short segment non-dysplastic Barrett’s Esophagus
EsoCheck® cell collection performed with 98 percent technical success and high DNA yields in real-world study of 1483 patients
NEW YORK, May 11, 2023 /PRNewswire/ — Lucid Diagnostics Inc. (NASDAQ:LUCD) (“Lucid” or the “Company”) a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (NASDAQ:PAVM, PAVMZ))))) (“PAVmed”), today 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.
“We are excited that Lucid had a strong presence and it’s technologies garnered widespread interest at this year’s DDW conference,” said Suman Verma, M.D., Ph.D., Lucid Senior Vice President, and Chief Scientific Officer. “The excellent EsoGuard and EsoCheck data presented at the conference strongly support recently updated professional society guidelines that have established non-endoscopic biomarker testing, such as EsoGuard performed on samples collected with EsoCheck, as an acceptable alternative to endoscopy to serve as a widespread tool to detect esophageal precancer,”
“EsoGuard’s overall sensitivity remains excellent, including the detection of one patient with silent esophageal cancer; it’s performance in short segment Barrett’s Esophagus (BE)—the most prevalent esophageal precancer subgroup and most challenging to detect—is particularly impressive. This success can be attributed to EsoGuard’s unrivaled ability to detect even the earliest epigenetic changes in esophageal precancer, as well as EsoCheck’s proprietary Collect+Protect® technology’s ability to provide anatomically precise, and protected sampling of lower esophageal cells,” said Dr. Verma.
“We are also gratified that the tolerability, technical success rate and DNA yield of EsoCheck cell sampling, documented in a very large real-world cohort, remains very high. We believe these data confirm the potential for EsoGuard, performed on samples collected with EsoCheck, to prevent highly lethal esophageal cancer through widespread precancer detection,” Dr. Verma added.
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 percent) underwent successful noninvasive esophageal cell sampling using the EsoCheck device.
EsoGuard sensitivity was 100 percent 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 percent and 37 percent, 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 percent of patients, in less than three minutes on average. It was broadly well-tolerated with 86 percent 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 six percent to two percent.
