Lucid Diagnostics Announces Peer-Reviewed Publication of Positive Results from Three Clinical Utility Studies

Rhea-AI Summary

Lucid Diagnostics Inc. (Nasdaq: LUCD) has announced the publication of three clinical utility studies demonstrating the real-world clinical utility of Lucid's EsoGuard Esophageal DNA test to detect esophageal precancer. The studies document near-perfect concordance between EsoGuard results and the prescribing physician's decision whether to refer patients for upper endoscopy, with 100 percent of EsoGuard-positive patients being referred for confirmatory upper endoscopy. These results eliminate the need for hundreds of costly, invasive, and inconvenient endoscopies, demonstrating that EsoGuard allows physicians to appropriately triage at-risk patients, consistent with established professional society guidelines, and ensure cost-effective utilization of endoscopy in esophageal precancer detection.

Positive

• Three clinical utility studies demonstrate the real-world clinical utility of EsoGuard Esophageal DNA test to detect esophageal precancer
• Near-perfect concordance between EsoGuard results and the prescribing physician's decision whether to refer patients for upper endoscopy
• 100 percent of EsoGuard-positive patients were referred for confirmatory upper endoscopy, eliminating the need for costly, invasive, and inconvenient endoscopies

Negative

• None.

Studies demonstrate real-world clinical utility of EsoGuard testing to detect esophageal precancer

NEW YORK, Dec. 12, 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 that three manuscripts providing interim results from the Prospective REView of Esophageal Precancer DetectioN in AT-Risk Patients (PREVENT) Registry, the CLinical Utility of EsoGuard (CLUE) study, and full data from the San Antonio Firefighter study, have been published—the first peer-reviewed publications demonstrating real-world clinical utility of Lucid's EsoGuard^® Esophageal DNA test to detect esophageal precancer.

The publications are:

• PREVENT Registries - Englehardt R, Samarasena JB, Bildzukewicz NA, Hamblin R, Lee VT, deGuzman BJ, Aklog L. (2023). Real-World Experience and Clinical Utility of EsoGuard^® – Interim Data from the Lucid Registry. J Gastro & Digestive Systems, 7(2), 43-53. Interim analysis of 409 of 517 enrolled patients with complete clinical utility data in the PREVENT and PREVENT-FF registries of patients undergoing EsoGuard testing by Lucid personnel.
• CLUE Study - Lister D, Fine A, Maheshwari S, Bradley PS, Lee VT, deGuzman BJ, Verma S, Aklog L. Clinical Utility of EsoGuard^® on Samples Collected with EsoCheck^® as a Triage to Endoscopy for Identification of Barrett's Esophagus – Interim Data from the CLUE Study. Archives of Clinical and Biomedical Research, 7 (2023): 626-634. Interim analysis of 220 of 275 enrolled patients with complete clinical utility data in the prospective, multicenter CLUE study of at-risk patients referred for EsoGuard testing.
• San Antonio Firefighter Study - Hamblin R, Lee VT, DeGuzman BJ, Verma S, Aklog L (2023). Clinical Utility of EsoGuard^® as a Barrett's Esophagus Triage Test for On-duty Firefighters. J Gastrointest Dig Syst 13: 764. Prospectively collected and retrospectively analyzed clinical utility data in 391 San Antonio firefighters who underwent EsoGuard testing at #CheckYourFoodTube Precancer Testing Events.

Collectively, the published studies document near-perfect concordance between EsoGuard results and the prescribing physician's decision whether to refer patients for upper endoscopy. 100 percent of EsoGuard-positive patients were referred for confirmatory upper endoscopy and approximately 98 percent of EsoGuard-negative patients were not—eliminating the need for hundreds of costly, invasive, and inconvenient endoscopies. These results demonstrate that, in real-world use, EsoGuard allows physicians to appropriately triage at-risk patients, consistent with established professional society guidelines, and ensure cost-effective utilization of endoscopy in esophageal precancer detection.

The CLUE study has completed enrollment and data from the full cohort of over 500 patients, including data on patient compliance with referral for endoscopy, will be released and submitted for publication when patient follow-up and data analysis is complete. The PREVENT registries are open-ended and have enrolled over 600 patients to date, penetrating even further into the patient journey, beyond the initial medical decision-making. Additional publications on the expanded registry cohorts are planned in the coming months.

"These clinical utility studies, encompassing over 1,000 patients, clearly demonstrate that prescribing physicians are properly leveraging EsoGuard results to guide their medical decision making," said Victoria T. Lee, M.D., Senior Vice President and Chief Medical Officer of Lucid and PAVmed, who oversees Lucid's clinical research activities. "EsoGuard allowed physicians to effectively triage patients at increased risk for esophageal precancer to endoscopy. We look forward to ongoing expansion of our increasingly robust EsoGuard clinical utility and validity evidence base."

"The publication of three clinical utility studies, with excellent results, in peer-reviewed journals, provides us with critical evidence to expand our ongoing engagement with commercial payors on medical policy and coverage for EsoGuard," said Natalie Carfora, Lucid's Vice President, Market Access of Lucid. "These outstanding clinical utility results complement existing clinical validity data on EsoGuard's unprecedented precancer detection performance. This evidence, coupled with multiple national society guidelines and consensus statements supporting EsoGuard esophageal precancer detection, provides us with a strong foundation for our ongoing market access and reimbursement efforts."

About Lucid Diagnostics

Lucid Diagnostics Inc. is a commercial-stage medical diagnostics company focused on cancer prevention, 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, is the first and only commercially available diagnostic test capable of serving as a widespread screening tool for at-risk patients to mitigate the risks of cancer and cancer deaths through early detection of esophageal precancer.

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 is the ticker symbol for Lucid Diagnostics Inc.?

The ticker symbol for Lucid Diagnostics Inc. is LUCD on the Nasdaq stock exchange.

What do the clinical utility studies of EsoGuard Esophageal DNA test demonstrate?

The clinical utility studies demonstrate the real-world clinical utility of EsoGuard Esophageal DNA test to detect esophageal precancer, with near-perfect concordance between EsoGuard results and the prescribing physician's decision whether to refer patients for upper endoscopy.

How many patients were included in the clinical utility studies?

The clinical utility studies encompass over 1,000 patients, providing robust evidence for the effectiveness of EsoGuard in triaging at-risk patients for esophageal precancer detection.

What percentage of EsoGuard-positive patients were referred for confirmatory upper endoscopy?

100 percent of EsoGuard-positive patients were referred for confirmatory upper endoscopy, ensuring appropriate triage of at-risk patients.

What is the role of Lucid's Senior Vice President and Chief Medical Officer in overseeing clinical research activities?

Victoria T. Lee, M.D., Senior Vice President and Chief Medical Officer of Lucid and PAVmed, oversees Lucid's clinical research activities and emphasizes the importance of EsoGuard in guiding medical decision making for physicians.

What is the significance of the clinical utility studies for market access and reimbursement efforts?

The outstanding clinical utility results complement existing clinical validity data on EsoGuard's unprecedented precancer detection performance, providing a strong foundation for ongoing market access and reimbursement efforts.

What is the future plan for additional publications on the expanded registry cohorts?

Additional publications on the expanded registry cohorts are planned in the coming months, providing further evidence of EsoGuard's effectiveness in esophageal precancer detection.