Lucid Diagnostics Announces Positive Data from ENVET-BE Clinical Utility Study of EsoGuard® Esophageal Precancer Testing

Rhea-AI Summary

Lucid Diagnostics (Nasdaq: LUCD) has released new real-world data from its ENVET-BE study, demonstrating the clinical utility of the EsoGuard® Esophageal DNA test as a non-invasive triage tool for detecting esophageal precancer and cancer. The study showed that patients triaged to invasive upper endoscopy (EGD) following a positive EsoGuard test had a 2.4-fold increase in positive yield compared to screening EGD alone in at-risk patients.

Key findings include:

• EGD confirmed Barrett's Esophagus (BE) in 50 out of 199 patients who received a positive EsoGuard result
• Post-triage EGD yield was 25%, compared to the expected 11% yield of EGD as a standalone screening tool
• Results support the use of EsoGuard as an alternative to EGD for esophageal precancer testing, potentially increasing compliance with screening guidelines and reducing esophageal cancer deaths

Positive

• EsoGuard test demonstrated a 2.4-fold increase in positive yield for detecting esophageal precancer compared to standard screening
• 25% post-triage EGD yield, significantly higher than the expected 11% yield of EGD alone
• Results support the use of EsoGuard as a non-invasive alternative to EGD for esophageal precancer testing
• Potential to increase compliance with esophageal precancer screening guidelines

Negative

• None.

Insights

Medical Research Analyst

The ENVET-BE study results are highly promising for Lucid Diagnostics' EsoGuard® test. The 2.4-fold increase in positive yield for detecting Barrett's Esophagus (BE) is significant. This efficiency boost could lead to:

• Improved resource allocation in endoscopy units
• Earlier detection of esophageal precancer
• Potentially reduced healthcare costs

However, it's important to note that while the 25% post-triage yield is impressive, it still means 75% of positive EsoGuard results didn't lead to BE diagnosis. This false positive rate needs consideration. The study's real-world setting enhances its relevance, but peer-review will be vital for validating these results. If confirmed, EsoGuard could significantly impact esophageal cancer screening protocols.

Oncology Doctor

This data is encouraging for esophageal cancer prevention. The 2.4-fold increase in BE detection is clinically meaningful. Considering that up to 90% of esophageal cancer patients were never diagnosed with precancer, EsoGuard could be a game-changer. It addresses a critical gap in current screening practices.

The non-invasive nature of EsoGuard may increase screening compliance, potentially leading to earlier interventions. However, we must be cautious about over-reliance on a single screening tool. The 25% positive predictive value, while improved, still leaves room for missed diagnoses. A comprehensive approach combining EsoGuard with other risk assessment tools might be ideal. Long-term studies on cancer prevention outcomes will be important to fully assess EsoGuard's impact on reducing esophageal cancer mortality.

Market Research Analyst

Lucid Diagnostics' EsoGuard® test shows strong market potential. The 2.4-fold increase in endoscopy yield addresses a significant pain point in gastroenterology practices. This could drive adoption among healthcare providers seeking to optimize resource utilization and improve patient care.

Key market drivers include:

• Alignment with professional guidelines
• Potential for increased screening compliance
• Improved efficiency in detecting esophageal precancer

However, market penetration may face challenges such as insurance coverage and competition from other non-invasive screening methods. The test's 75% false positive rate could also be a concern for some providers. Lucid will need to focus on education and real-world evidence to drive widespread adoption. If successful, EsoGuard could significantly expand Lucid's market share in the growing field of cancer prevention diagnostics.

Real-world data confirms utility of EsoGuard as a non-invasive triage tool to significantly increase positive yield of invasive upper endoscopy

NEW YORK, Aug. 6, 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 release of new real-world data from its ENVET-BE study supporting the clinical utility of the EsoGuard^® Esophageal DNA test  as a non-invasive triage tool to significantly increase the positive yield of invasive upper endoscopy (EGD) for detection of esophageal precancer (Barrett's Esophagus or BE) and cancer. The manuscript entitled Enhancing the Positive Predictive Value of EGD for Diagnosis of Barrett's Esophagus Through EsoGuard^® Triage, is currently available on the leading health sciences preprint server, MedRxiv, while undergoing peer review for publication. Patients triaged to invasive EGD following a positive non-invasive EsoGuard test had a 2.4-fold increase in the positive yield of those EGDs compared to the expected yield of screening EGD alone in at-risk patients.

"Up to 90% of esophageal cancer patients were never previously diagnosed with esophageal precancer," said ENVET-BE investigator Jayde E. Kurland, M.D., FACG, AGAF, a gastroenterologist and advanced endoscopist at Gastro Health in Lima, OH. "We found we were missing ~80% of patients in our busy endoscopy practice who should be eligible for esophageal precancer screening based on risk factors and gastroenterology guidelines. This study demonstrates that EsoGuard triage allows us to efficiently screen more patients, significantly improves the yield of endoscopy, and increases our ability to diagnose and treat disease before it develops into cancer. We have fully incorporated EsoGuard in our practice and believe it will serve a crucial role in esophageal precancer screening."

EGD confirmed a BE diagnosis in 50 of the 199 patients in a real-world commercial setting who underwent clinically directed EsoGuard testing and received a positive EsoGuard result.  This represents a post-triage EGD yield of 25%, a 2.4-fold increase over the expected 11% yield of EGD as a standalone screening tool in the at-risk population. These findings are consistent with those previously published by Greer et. al. in the American Journal of Gastroenterology for a study conducted at the Cleveland VA that utilized EsoGuard for screening high-risk veterans.

"The ENVET-BE study demonstrates that triaging at-risk patients with EsoGuard significantly increases the yield of EGD, which should lead to more efficient use of endoscopy resources while improving early detection of esophageal precancer," said Victoria T. Lee, M.D., Lucid's Chief Medical Officer. "These results support published professional society guidelines which include non-endoscopic biomarker tests, such as EsoGuard, as an acceptable alternative to EGD for esophageal precancer testing. Using EsoGuard to triage patients to EGD has the potential to increase compliance with esophageal precancer screening guidelines and reduce esophageal cancer deaths."

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 is the ENVET-BE study conducted by Lucid Diagnostics (LUCD)?

The ENVET-BE study is a clinical utility study that evaluated the effectiveness of EsoGuard® Esophageal DNA test as a non-invasive triage tool for detecting esophageal precancer and cancer.

How much did EsoGuard improve the detection rate of Barrett's Esophagus in the ENVET-BE study?

EsoGuard improved the detection rate of Barrett's Esophagus by 2.4-fold, increasing the positive yield of upper endoscopy (EGD) from an expected 11% to 25% in at-risk patients.

What are the potential benefits of using EsoGuard for esophageal precancer screening?

Using EsoGuard for screening can lead to more efficient use of endoscopy resources, improve early detection of esophageal precancer, increase compliance with screening guidelines, and potentially reduce esophageal cancer deaths.

How many patients in the ENVET-BE study were confirmed to have Barrett's Esophagus after a positive EsoGuard test?

Out of 199 patients who received a positive EsoGuard result and underwent upper endoscopy (EGD), 50 were confirmed to have Barrett's Esophagus.