Lucid Diagnostics Announces Positive Data from the First Prospective Clinical Validation Study of EsoGuard® Esophageal Precancer Testing in a Screening Population
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Insights
The recent findings regarding EsoGuard's sensitivity and negative predictive value are significant in the context of esophageal cancer detection. Esophageal cancer is often diagnosed at a late stage and the five-year survival rate is relatively low, highlighting the need for early detection methods. EsoGuard's high sensitivity rate of 92.9% suggests that the test can reliably identify the presence of precancerous cells, which is important for initiating early treatment and potentially improving patient outcomes. The negative predictive value of 98.6% implies that individuals with a negative test result can be reassured with high confidence that they do not have the disease.
However, the specificity rate of 72.2% indicates a relatively higher chance of false positives, which could lead to unnecessary anxiety and further invasive testing. This could impact healthcare costs and patient experience. The positive predictive value of 32.5%, while lower than desired, still represents a substantial improvement over current screening methods, as evidenced by the 2.5-fold increase in the positive yield of endoscopy.
From a research perspective, the integration of EsoGuard as a screening tool aligns with the shift towards personalized medicine and non-invasive testing. The benefits of such a tool include reduced need for endoscopies, which are more invasive, costly and carry higher risks. The study's support for EsoGuard's clinical validity and utility, combined with its alignment with national society guidelines, could influence insurance coverage decisions, thereby affecting the adoption rate of the test.
The economic implications of adopting EsoGuard as a widespread screening tool are multifaceted. Firstly, the potential for early detection of esophageal precancer could translate into cost savings for the healthcare system by reducing the number of advanced-stage cancer treatments, which are typically more expensive and less effective. Early intervention strategies can improve patient prognosis and reduce long-term healthcare costs associated with esophageal cancer management.
However, the adoption of EsoGuard also requires consideration of the initial costs of screening a large population, especially given the moderate positive predictive value. The cost-effectiveness of EsoGuard will depend on the balance between the costs of the test, the follow-up procedures for false positives and the savings from avoiding late-stage cancer treatments.
Furthermore, the potential inclusion of EsoGuard in medical policy coverage and its line of sight to CMS coverage could significantly impact the market for esophageal cancer screening. Positive coverage decisions by insurers could lead to increased demand for the test, thereby affecting Lucid Diagnostics' business prospects and potentially influencing the stock market perception of the company's value.
The esophageal cancer diagnostics market is evolving, with an emphasis on early detection and minimally invasive procedures. Lucid Diagnostics' EsoGuard fits well within this trend and could capture a significant market share if adopted as a standard screening tool. The study's findings that EsoGuard is a 'powerful screening tool' suggest that it has the potential to disrupt the current standard of care, which relies heavily on endoscopy.
Investor interest in Lucid Diagnostics may be influenced by the clinical validation of EsoGuard, as it represents a step towards broader market acceptance. Additionally, the company's affiliation with PAVmed provides a strategic advantage, as it can leverage existing relationships and infrastructure to accelerate the commercialization process.
However, market adoption will not only be influenced by clinical data but also by the receptiveness of physicians, patient awareness and insurance coverage decisions. The latter is particularly important, as it directly affects the affordability and accessibility of the test for patients. The long-term impact on Lucid Diagnostics' stock will depend on how these factors converge to drive EsoGuard's adoption and sales growth.
Prospective VA screening study demonstrates excellent EsoGuard sensitivity of
Authors conclude that EsoGuard is a "powerful screening tool" for esophageal precancer and cancer
"We are grateful to Dr. Greer and her co-investigators for this sentinel contribution to the clinical evidence supporting EsoGuard esophageal precancer testing," said Victoria T. Lee, M.D., Lucid's Chief Medical Officer. "Data from this clinical validation study, the first in an 'intended use' screening population, closely mirror EsoGuard performance data from two previously reported NCI-funded case-control clinical validation studies—the original multi-center study which first introduced the technology, and the recently completed BETRNet study whose results were posted as a preprint last year pending peer review and publication. Collectively, these three clinical validity studies demonstrate excellent EsoGuard sensitivity and negative predictive value, including unprecedented performance of a molecular diagnostic test in detecting a precancer. They strongly support EsoGuard's use as a widespread screening tool to prevent esophageal cancer through the early detection of esophageal precancer."
Dr. Lee added, "as previously reported, three published clinical utility studies have already documented near-perfect concordance between EsoGuard results and physician referral for upper gastrointestinal endoscopy. Physicians consistently utilized EsoGuard results to appropriately triage at-risk patients resulting in more cost-effective utilization of endoscopy for esophageal precancer detection. The clinical validity and clinical utility data, coupled with multiple national society guidelines and consensus statements supporting EsoGuard esophageal precancer detection, provides a strong foundation of critical evidence needed to support broad EsoGuard medical policy coverage and a line of sight to CMS coverage, in particular."
The manuscript reports on 128 eligible patients with no prior history of upper gastrointestinal endoscopy (EGD) who met criteria for esophageal precancer screening based on current American College of Gastroenterology 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). 124 patients underwent successful non-endoscopic esophageal cell sampling using the EsoCheck® Cell Collection Device followed by EGD. Biopsies were performed during EGD if esophageal precancer was suspected based on appearance. Twelve patients with esophageal precancer and two patients with esophageal cancer were confirmed on endoscopy for an overall disease prevalence of
The authors conclude that "[g]iven the increasing prevalence of [esophageal cancer]… and improved effectiveness of ablative and endoscopic resection techniques available to patients with early stages of disease, this screening platform [EsoGuard] opens the window to improved prognosis for [esophageal cancer] by increasing access to minimally invasive, well tolerated office-based testing."
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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