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
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.
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.
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.
About Lucid Diagnostics
Lucid Diagnostics Inc. is a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. Lucid is focused on the millions of patients with gastroesophageal reflux disease (GERD), also known as chronic heartburn, who are at risk of developing esophageal precancer and cancer. Lucid's EsoGuard® Esophageal DNA Test, performed on samples collected in a brief, noninvasive office procedure with its EsoCheck® Esophageal Cell Collection Device, is the first and only commercially available diagnostic test capable of serving as a widespread screening tool to prevent cancer and cancer deaths through early detection of esophageal precancer in at-risk GERD patients.
This press release includes forward-looking statements that involve risk and uncertainties. Forward-looking statements are any statements that are not historical facts. Such forward-looking statements, which are based upon the current beliefs and expectations of Lucid Diagnostics' management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of Lucid Diagnostics' common stock; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required to advance Lucid Diagnostics' products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from Lucid Diagnostics' clinical and preclinical studies; whether and when Lucid Diagnostics' products are cleared by regulatory authorities; market acceptance of Lucid Diagnostics' products once cleared and commercialized; Lucid Diagnostics' ability to raise additional funding as needed; and other competitive developments. In addition, Lucid Diagnostics continues to monitor the COVID-19 pandemic and the pandemic's impact on Lucid Diagnostics' businesses. These factors are difficult or impossible to predict accurately and many of them are beyond Lucid Diagnostics' control. In addition, new risks and uncertainties may arise from time to time and are difficult to predict. For a further list and description of these and other important risks and uncertainties that may affect Lucid Diagnostics' future operations, see Part I, Item 1A, "Risk Factors," in Lucid Diagnostics' most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission. Lucid Diagnostics disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.