Lucid Diagnostics' ENVET-BE Clinical Utility Study of EsoGuard® Esophageal Precancer Testing Accepted for Peer-Reviewed Publication

Rhea-AI Summary

Lucid Diagnostics (Nasdaq: LUCD) announced the acceptance of its ENVET-BE clinical utility study for publication in Gastroenterology & Hepatology, marking the fifth peer-reviewed publication supporting its EsoGuard® Esophageal DNA Test.

The study, examining data from 199 EsoGuard-positive patients who underwent confirmatory upper endoscopy (EGD), demonstrated that EsoGuard significantly improves the detection of esophageal precancer (Barrett's Esophagus or BE). Key findings show:

• 2.4-fold higher diagnostic yield for BE compared to screening EGD alone
• Nearly three-fold higher yield in patients meeting American College of Gastroenterology screening criteria

This research validates EsoGuard as an effective non-invasive triage tool, allowing most at-risk patients to avoid invasive procedures while enhancing the efficiency of endoscopy resource utilization. The study supports ongoing efforts to secure positive commercial insurance coverage policies, following recent success with Highmark Blue Cross Blue Shield.

Positive

• Fifth peer-reviewed publication validates EsoGuard's clinical utility
• 2.4x higher diagnostic yield compared to standard screening
• Recent success in securing Highmark Blue Cross Blue Shield coverage
• Strong clinical evidence supporting insurance coverage expansion

Negative

• None.

Study confirms clinical utility of EsoGuard as a non-invasive triage tool to significantly increase positive yield of invasive upper endoscopy

NEW YORK, March 18, 2025 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company"), a commercial-stage, cancer prevention medical diagnostics company and subsidiary of PAVmed Inc. (Nasdaq: PAVM), today announced that its ENVET-BE clinical utility study has been accepted for publication in Gastroenterology & Hepatology—the fifth peer-reviewed publication of clinical utility data for Lucid's EsoGuard^® Esophageal DNA Test, and the second to present findings from a real-world screening population. The manuscript, entitled Enhancing the Diagnostic Yield of EGD for Diagnosis of Barrett's Esophagus Through Methylated DNA Biomarker Triage, demonstrates that confirmatory upper endoscopy (EGD) performed in EsoGuard-positive patients had a substantially higher diagnostic yield for detecting esophageal precancer (Barrett's Esophagus or BE) than the expected yield of screening EGD alone in at-risk patients.

"This study cements EsoGuard's critical role as a non-invasive tool to triage at-risk patients to invasive EGD, allowing the vast majority of patients recommended for esophageal precancer testing to avoid an invasive procedure. This is precisely what non-invasive triage tests are designed to do," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "The study further strengthens EsoGuard's already robust clinical evidence base. We previously demonstrated near perfect concordance between EsoGuard results and physician referral for EGD as well as excellent patient compliance with EGD referral and now document increased EGD diagnostic yield with EsoGuard testing. This comprehensive clinical utility data package supports our ongoing efforts to secure positive commercial insurance coverage policies, building on our recent success with Highmark Blue Cross Blue Shield. The study strongly supports EsoGuard's economic value by demonstrating its potential to increase compliance with BE screening guidelines while promoting more efficient use of more costly endoscopy resources."

The ENVET-BE study reviewed real-world data from a cohort of 199 EsoGuard-positive patients who completed confirmatory EGD. The overall positive diagnostic yield for BE was 2.4-fold higher than the expected yield of screening EGD alone, based on disease prevalence within an at-risk population. The yield was nearly three-fold higher in patients meeting American College of Gastroenterology (ACG) screening criteria. The study authors concluded that "EsoGuard enriches the population undergoing EGD and, compared to a screening strategy that relies on EGD alone, it improves overall diagnostic yield. This could potentially help direct more efficient use of endoscopy resources while improving BE detection in at-risk patients."

About Lucid Diagnostics
Lucid Diagnostics Inc. is a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM). 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, represent the first and only commercially available tools designed with the goal of preventing cancer and cancer deaths through widespread, early detection of esophageal precancer in at-risk patients.

For more information, please visit www.luciddx.com and for more information about its parent company PAVmed, please visit www.pavmed.com.

Forward-Looking Statements
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's 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's common stock; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required to advance Lucid's products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from Lucid's clinical and preclinical studies; whether and when Lucid's products are cleared by regulatory authorities; market acceptance of Lucid's products once cleared and commercialized; Lucid's ability to raise additional funding as needed; and other competitive developments. In addition, Lucid continues to monitor the COVID-19 pandemic and the pandemic's impact on Lucid's businesses. These factors are difficult or impossible to predict accurately and many of them are beyond Lucid's 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's future operations, see Part I, Item 1A, "Risk Factors," in Lucid's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, "Risk Factors" in any Quarterly Report on Form 10-Q filed by Lucid Diagnostics after its most recent Annual Report.  Lucid 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.

 

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SOURCE Lucid Diagnostics

FAQ

What were the key findings of Lucid Diagnostics' (LUCD) ENVET-BE study for EsoGuard testing?

The study showed EsoGuard achieved 2.4x higher diagnostic yield for Barrett's Esophagus compared to standard screening, and nearly 3x higher yield in patients meeting ACG screening criteria.

How many patients were included in LUCD's ENVET-BE clinical utility study?

The study analyzed real-world data from 199 EsoGuard-positive patients who completed confirmatory upper endoscopy (EGD).

What is the significance of EsoGuard's publication in Gastroenterology & Hepatology for LUCD?

It's the fifth peer-reviewed publication validating EsoGuard's clinical utility, strengthening evidence for insurance coverage and confirming its role as an effective non-invasive triage tool.

How does EsoGuard's triage approach benefit healthcare resource utilization?

EsoGuard helps avoid unnecessary invasive procedures while improving Barrett's Esophagus detection, leading to more efficient use of endoscopy resources.