NCI-Sponsored Study Shows Positive Data for Lucid Diagnostics' EsoGuard® Esophageal DNA Test in Patients Without Symptomatic GERD

Rhea-AI Summary

Lucid Diagnostics (LUCD) has announced positive results from a National Cancer Institute-sponsored study of its EsoGuard® Esophageal DNA Test in detecting esophageal precancer (Barrett's Esophagus) among at-risk patients without GERD symptoms. The study demonstrated an excellent 100% negative predictive value for precancer detection and showed a Barrett's Esophagus prevalence of 8.4% in asymptomatic patients.

The findings support expanding EsoGuard testing to a broader population, aligning with American Gastroenterological Association guidelines. These positive results have led to a larger ongoing five-year multicenter clinical study supported by an $8 million NIH R01 grant. According to the company, if these results are replicated in the ongoing study, the approximately $60 billion market opportunity for EsoGuard could increase by up to 70 percent.

Positive

• 100% negative predictive value in detecting esophageal precancer
• Potential 70% increase in $60 billion market opportunity
• Secured $8 million NIH R01 grant for expanded clinical study
• 8.4% Barrett's Esophagus detection rate comparable to GERD patients

Negative

• Study results still need replication in larger multicenter trial
• Current findings to preliminary study pending peer review

Study supports expanded indication and market opportunity for EsoGuard esophageal precancer testing

NEW YORK, April 24, 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 positive data from a National Cancer Institute (NCI)-sponsored study demonstrating that its EsoGuard^® Esophageal DNA Test can effectively detect esophageal precancer (Barrett's Esophagus or BE) among at-risk patients without symptoms of chronic gastroesophageal reflux disease (GERD), such as heartburn. These results support EsoGuard esophageal precancer testing in an expanded target population, consistent with existing American Gastroenterological Association (AGA) guidelines and has the potential to substantially increase the market opportunity. Positive results from this study led to a larger ongoing five-year multicenter clinical study evaluating EsoGuard in asymptomatic patients supported by an $8 million National Institutes of Health (NIH) R01 grant.

The study was conducted by investigators at Case Western Reserve University (CWRU) and University Hospitals (UH) and enrolled patients without GERD symptoms who otherwise met AGA recommendations for BE screening. EsoGuard demonstrated excellent negative predictive value (NPV) of 100% for detecting esophageal precancer, consistent with its unprecedented precancer detection reported across multiple peer-reviewed clinical validity studies in patients with symptomatic GERD. The study also showed a BE prevalence of 8.4%, a rate comparable to the established prevalence in patients with symptomatic GERD. The manuscript, entitled Nonendoscopic Detection of Barrett's Esophagus in Patients Without GERD Symptoms, is currently available on the leading health sciences preprint server, MedRxiv, and has been submitted for peer-reviewed publication.

"This study represents yet another piece of evidence that EsoGuard is highly effective at detecting esophageal precancer to prevent cancer," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "The meaningful BE prevalence reported in this study establishes the asymptomatic population as a viable target for BE screening. If these promising results are replicated in the ongoing multicenter NIH-sponsored study, the approximately $60 billion market opportunity for EsoGuard esophageal precancer testing could increase by as much as 70 percent."

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 about Lucid, 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 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. 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, 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 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.

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SOURCE Lucid Diagnostics

FAQ

What were the key findings of the NCI-sponsored study for Lucid Diagnostics' EsoGuard test (LUCD)?

The study showed 100% negative predictive value for detecting esophageal precancer and demonstrated 8.4% Barrett's Esophagus prevalence in patients without GERD symptoms.

How could the EsoGuard study results impact LUCD's market opportunity?

If replicated in the ongoing NIH study, the current $60 billion market opportunity could increase by up to 70% through expansion to asymptomatic patients.

What is the significance of the $8 million NIH grant for Lucid Diagnostics (LUCD)?

The grant supports a larger five-year multicenter clinical study evaluating EsoGuard in asymptomatic patients, following the positive initial results.

How does the Barrett's Esophagus prevalence in asymptomatic patients compare to GERD patients for LUCD's EsoGuard?

The study found 8.4% BE prevalence in asymptomatic patients, comparable to the established prevalence in symptomatic GERD patients.