Study demonstrates outstanding clinical utility including an exceptionally high 85% patient compliance with referral to confirmatory upper endoscopy following EsoGuard esophageal precancer testing
NEW YORK, Dec. 11, 2024 /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 the manuscript for its CLinical Utility of EsoGuard (CLUE) study has been accepted for publication in the peer-reviewed journal Medicina. This is the fourth peer-reviewed publication presenting outstanding clinical utility data for the EsoGuard® Esophageal DNA Test. In addition to demonstrating near-perfect provider decision impact, consistent with previous EsoGuard clinical utility studies, the study documented an exceptionally high 85% patient compliance with referral to confirmatory upper endoscopy (EGD) following EsoGuard esophageal precancer testing in a real-world clinical setting.
Lucid Diagnostics Inc., markets the first and only commercial tools for widespread early detection of esophageal precancer and cancer – the EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device. (PRNewsfoto/Lucid Diagnostics)
"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 and we are deeply grateful to our investigators across eight clinical centers for their commitment to esophageal cancer prevention," 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. This patient compliance data and the study's full provider impact data supplements our strong evidence base of clinical validity, clinical utility and analytical validity data supporting our ongoing discussions with payors and other key stakeholders."
The full manuscript, entitled 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) is expected to be available in an upcoming online edition of Medicina, and follows the CLUE interim data report which was previously published in the Archives of Clinical and Biomedical Research in December of 2023.
The prospective, multicenter CLUE study enrolled patients who met 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 demonstrated strong provider decision impact—100% of EsoGuard-positive patients were referred for confirmatory 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. 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."
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.
