Lucid Diagnostics Announces Publication of Analytical Validation Study of EsoGuard® for Early Detection of Esophageal Precancer and Cancer

Rhea-AI Summary

Lucid Diagnostics, a subsidiary of PAVmed, has published an analytical validation study of its EsoGuard® Esophageal DNA test in the peer-reviewed journal Diagnostics. The study demonstrates excellent analytical performance of the EsoGuard assay on samples collected with the EsoCheck® Esophageal Cell Collection Device for diagnosing esophageal precancer (Barrett's Esophagus) and esophageal adenocarcinoma.

Key findings include:

• 89% analytical sensitivity
• 100% analytical specificity
• 96% analytical accuracy
• 100% inter- and intra-assay precision

EsoGuard uses next-generation sequencing to detect DNA methylation at 31 sites on two genes associated with conditions along the BE-EAC spectrum. This study complements EsoGuard's existing clinical validity and utility evidence base.

Positive

• Publication of analytical validation study in a peer-reviewed journal
• High analytical performance metrics: 89% sensitivity, 100% specificity, 96% accuracy
• 100% inter- and intra-assay precision for EsoGuard test
• Complementary to existing clinical validity and utility evidence

Negative

• None.

Study demonstrates excellent analytical accuracy, repeatability, and reproducibility of the assay

NEW YORK, Aug. 20, 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 the peer-reviewed publication of an analytical validation study of its EsoGuard^® Esophageal DNA test for the diagnosis of esophageal precancer (Barrett's Esophagus or BE) and esophageal adenocarcinoma (EAC) on samples collected non-endoscopically using Lucid's EsoCheck^® Esophageal Cell Collection Device. The manuscript, entitled Analytical Validation of a DNA Methylation Biomarker Test for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma from Samples Collected Using EsoCheck^®, a Non-Endoscopic Esophageal Cell Collection Device, has been published in the peer-reviewed journal Diagnostics, and is currently available via open access online.

"This analytical validation study strongly complements EsoGuard's extensive peer-reviewed, published clinical validity and clinical utility evidence base," said Suman Verma, M.D., PhD, Lucid's Chief Scientific Officer. "The results demonstrate very robust analytical performance of the EsoGuard assay performed in our CLIA-certified, CAP-accredited, NY State-approved commercial laboratory."

The publication details comprehensive studies demonstrating excellent analytical performance of the EsoGuard assay on samples collected with EsoCheck, including 89% analytical sensitivity, 100% analytical specificity, 96% analytical accuracy, and 100% inter- and intra-assay precision. EsoGuard utilizes next-generation sequencing (NGS) to detect DNA methylation at 31 sites on two genes, vimentin (VIM) and cyclin A1 (CCNA1), which have been shown to be associated with conditions along the BE-EAC spectrum.

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 are the key findings of Lucid Diagnostics' EsoGuard analytical validation study?

The study showed 89% analytical sensitivity, 100% analytical specificity, 96% analytical accuracy, and 100% inter- and intra-assay precision for the EsoGuard Esophageal DNA test when used with EsoCheck samples.

How does the EsoGuard test detect esophageal precancer and cancer?

EsoGuard uses next-generation sequencing to detect DNA methylation at 31 sites on two genes, vimentin (VIM) and cyclin A1 (CCNA1), which are associated with conditions along the Barrett's Esophagus-Esophageal Adenocarcinoma spectrum.

Where was Lucid Diagnostics' EsoGuard validation study published?

The analytical validation study was published in the peer-reviewed journal Diagnostics and is available via open access online.

What is the significance of this study for Lucid Diagnostics (NASDAQ: LUCD)?

This study strongly complements EsoGuard's extensive peer-reviewed clinical validity and utility evidence base, demonstrating robust analytical performance of the assay in Lucid's commercial laboratory.