Lucid Diagnostics Announces Positive Data from its ESOGUARD BE-1 Prospective, International, Multicenter Clinical Validation Study of EsoGuard® Esophageal Precancer Testing in a Screening Population
Lucid Diagnostics announced positive results from its ESOGUARD BE-1 clinical validation study for EsoGuard, a test for detecting esophageal precancer. The study showed an 87.5% sensitivity and a 98.6% negative predictive value (NPV). The study was conducted across multiple international centers, including major U.S. and European institutions. The results support the upcoming Medicare LCD pre-submission and ongoing commercial payor engagements. The study involving 93 subjects confirmed the test's efficiency and safety, potentially making esophageal cancer screening more accessible and effective.
- EsoGuard demonstrated 87.5% sensitivity and 98.6% NPV in detecting esophageal precancer.
- The study was international and multicenter, including prestigious institutions.
- Data supports Medicare LCD pre-submission and ongoing commercial payor engagements.
- The study confirmed the test's efficiency, safety, and potential to improve esophageal cancer screening.
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Insights
The recent results from Lucid Diagnostics' ESOGUARD BE-1 study are highly promising and could significantly impact the esophageal precancer screening landscape. The study demonstrated an 87.5% sensitivity and a 98.6% negative predictive value (NPV), suggesting that the EsoGuard test is highly effective in identifying individuals without esophageal precancer. These results reinforce the previously reported data from other studies, which show consistent and robust performance of the test. For retail investors, the high sensitivity means that the EsoGuard test successfully identifies a large proportion of true positive cases, while the high NPV indicates that a negative test result can be relied upon to rule out the disease.
This consistency and reproducibility of results across multiple studies offer a solid foundation for regulatory and commercial payor approvals, which could expand market adoption. The implications for stakeholders are significant: increased early detection of esophageal precancer can lead to early interventions, potentially reducing the incidence of esophageal adenocarcinoma—a highly lethal cancer. Additionally, the non-invasive nature of the test, compared to the traditional endoscopy, could make it more accessible and acceptable to a broader population.
From a financial perspective, the positive data from multiple validation studies suggest a strong potential for market penetration. The upcoming Medicare LCD pre-submission meeting and ongoing commercial payor engagements are critical milestones. If Medicare and other insurers decide to cover the EsoGuard test, it could significantly boost Lucid Diagnostics' revenue streams. The market for esophageal cancer screening is substantial, considering the prevalence of risk factors such as chronic heartburn and obesity in the population. This can translate into a high demand for screening tools like EsoGuard.
For retail investors, it's essential to consider the revenue potential alongside the company's ability to navigate regulatory and reimbursement landscapes. The fact that the test is less invasive than traditional methods could enhance its adoption rate, making it a more attractive option for both patients and healthcare providers. However, it's important to monitor how the company manages its expenditures related to these engagements and the timing of potential revenues, as these factors will influence the stock's performance.
The EsoGuard test is positioned to disrupt the current esophageal cancer screening market. The high sensitivity and NPV metrics suggest that the test is reliable, which can build trust among healthcare providers and patients. The non-invasive nature of the test compared to traditional endoscopy could also drive higher screening uptake rates. Given that esophageal cancer has a high mortality rate due to late diagnosis, a tool that can effectively screen for precancerous conditions is likely to be well-received in the market.
For the retail investor, understanding the market dynamics is essential. The barriers to entry for similar diagnostic tests are relatively high due to the need for rigorous clinical validation, which EsoGuard has successfully navigated. This advantage, coupled with strong clinical support and potential endorsements from medical societies, positions Lucid Diagnostics favorably in the market. However, investors should keep an eye on competitor activities and advancements in screening technologies, as these could impact market share and pricing strategies.
Prospective screening study demonstrates excellent EsoGuard sensitivity of
Previously announced positive data from a separate prospective VA screening study also accepted for peer-reviewed publication
Studies further strengthen EsoGuard's clinical validity data in support of upcoming Medicare LCD pre-submission meeting and ongoing commercial payor engagements
The ESOGUARD BE-1 study was led by Nicholas J. Shaheen, M.D., M.P.H., Professor of Medicine and Epidemiology at the University of North Carolina School of Medicine, a leading esophageal precancer expert and lead author of the American College of Gastroenterology (ACG) guidelines on esophageal precancer screening. Study sites included leading academic medical centers, such as Baylor College of Medicine, University of
The manuscript for the
"We are grateful to Dr. Shaheen and his co-investigators for this valuable contribution to the clinical evidence supporting EsoGuard esophageal precancer testing," said Victoria T. Lee, M.D., Lucid's Chief Medical Officer. "This second multi-center clinical validation study in an intended use screening population demonstrates nearly identical EsoGuard performance compared to two previously reported National Cancer Institute (NCI)-funded case-control studies—a multi-center pivotal study published in Science Translational Medicine introducing the technology and a multi-center study from the BETRNet consortium recently published in the American Journal of Gastroenterology. Additionally, the previously announced and now peer-reviewed results of the
Dr. Lee added, "As previously reported, three published clinical utility studies have already documented that physicians consistently utilized EsoGuard results to appropriately triage at-risk patients, which can result in more cost-effective utilization of endoscopy for esophageal precancer detection. These clinical validation and clinical utility data, coupled with multiple national society guidelines and consensus statements supporting non-endoscopic esophageal precancer detection, provides a robust clinical evidence base in support of our upcoming Medicare LCD pre-submission meeting and ongoing commercial payor engagements."
The BE1 manuscript reports EsoGuard performance in 93 subjects who met criteria for esophageal precancer screening based on American College of Gastroenterology (ACG) guidelines (presence of chronic heartburn and at least three of six additional risk factors—age over 50 years, male sex, white race, obesity, smoking and positive family history), underwent EsoCheck cell collection, had binary EsoGuard results, and a definitive final diagnosis established by upper gastrointestinal endoscopy and biopsies. Of these 93 subjects contributing to the primary endpoint analysis, eight had BE without dysplasia, for a disease prevalence of
The authors conclude that "…EsoGuard DNA biomarker testing was well-tolerated, convenient, safe, and efficient…with a PPV and a NPV that can appropriately guide clinical decision-making…Improved accessibility of non-endoscopic, in-office testing could increase BE screening rates, improve early disease detection, and ensure BE patients receive appropriate endoscopic surveillance and treatment to avoid progression to EAC."
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 - 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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FAQ
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