The American Foregut Society Formally Requests Medical Policy Coverage of EsoGuard® to Enhance Early Detection of Esophageal Cancer

Rhea-AI Summary

The American Foregut Society (AFS) has formally requested health insurance providers to update their medical policies to include Lucid Diagnostics' (Nasdaq: LUCD) EsoGuard® Esophageal DNA test as a covered service. This move aims to enhance early detection of esophageal precancer (Barrett's Esophagus) and prevent highly lethal esophageal cancer. The AFS, a leading society of gastroenterologists and surgeons, highlighted the strong scientific evidence supporting EsoGuard as a minimally invasive screening alternative to endoscopy.

The AFS emphasized that expanding access to EsoGuard will empower providers with an essential triage for upper endoscopy, enabling early detection of Barrett's Esophagus. As a point-of-care test in primary care offices, EsoGuard can reduce health disparities in endoscopy access. The society urged immediate coverage of the test, aligning with recent gastroenterology society guidelines and state legislation mandating coverage of such biomarker tests.

Positive

• AFS formally requested insurance coverage for EsoGuard® Esophageal DNA test
• Strong endorsement from a leading medical society for Lucid Diagnostics' product
• Potential for increased accessibility and adoption of EsoGuard test
• Alignment with recent gastroenterology guidelines and state legislation

Negative

• None.

Insights

Medical Research Analyst

The American Foregut Society's (AFS) formal request for insurance coverage of EsoGuard® is a significant development in the fight against esophageal cancer. This minimally invasive screening alternative to endoscopy could potentially revolutionize early detection of Barrett's Esophagus (BE), a precursor to esophageal cancer.

The AFS's endorsement carries substantial weight, given their expertise in gastrointestinal diseases. Their advocacy highlights EsoGuard's potential to address health disparities by making screening more accessible, particularly in primary care settings. This aligns with broader healthcare trends focusing on preventive care and early intervention.

However, it's important to note that while this request is a positive step, it doesn't guarantee immediate coverage by insurers. The process of updating medical policies can be lengthy and complex. Investors should monitor how quickly and widely insurers respond to this request, as it will significantly impact Lucid Diagnostics' market penetration and revenue potential.

Financial Analyst

This development could be a game-changer for Lucid Diagnostics (LUCD). The AFS's endorsement of EsoGuard® potentially paves the way for broader insurance coverage, which could significantly boost adoption rates and, consequently, Lucid's revenue streams.

However, investors should temper their enthusiasm with caution. While positive, this news doesn't guarantee immediate financial benefits. The timeline for insurance companies to update their policies and the extent of coverage remain uncertain. Additionally, Lucid will likely need to invest in education and marketing to capitalize on this opportunity fully.

Looking ahead, key metrics to watch include:

• The rate at which insurance companies add EsoGuard to their covered services
• Changes in EsoGuard test volumes
• Lucid's revenue growth and path to profitability

This news represents a positive step, but Lucid's ability to execute and translate this opportunity into financial success will be crucial.

Request for insurance coverage aims to enhance early detection and treatment of esophageal precancer to prevent highly lethal esophageal cancer

NEW YORK, Aug. 13, 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 that the American Foregut Society (AFS), a leading society of gastroenterologists and surgeons collaborating to improve patient outcomes, including in esophageal disease, has formally requested that health insurance providers update their medical policies to include the EsoGuard^® Esophageal DNA test as a covered service.

The open letter, posted on the society website, highlights the critical need for early detection of esophageal precancer (Barrett's Esophagus or BE) to prevent highly lethal esophageal cancer, the strong scientific evidence supporting the use of EsoGuard as a minimally invasive screening alternative to endoscopy, and EsoGuard's incorporation in the practices of AFS physicians. The letter strongly advocates for medical policy coverage of EsoGuard consistent the most recent gastroenterology society guidelines and legislation in many states mandating coverage of biomarker tests like EsoGuard. 

"We are confident that expanding access to the EsoGuard test will empower providers with an essential triage for upper endoscopy (EGD) that enables the early detection of BE," wrote Reginald Bell, M.D., FACS, the Chair of the AFS Board, on behalf the society. "The goal of early BE detection is to facilitate prompt treatment and surveillance, ultimately reducing the risk of cancer progression. By being available as a point-of-care test in primary care offices, EsoGuard directly reduces health disparities in endoscopy access, aligning with the mission of the American Foregut Society. We urge you to consider the immediate coverage of the EsoGuard test."

"The AFS is the preeminent society of renowned physicians and surgeons, focusing on esophageal cancer and other disease of the foregut. We are grateful that the society has used its platform to advocate on behalf of patients at risk for this highly lethal but preventable cancer," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "The AFS's vocal advocacy highlights the critical need for accessible and effective screening tools, such as EsoGuard, to detect esophageal precancer to prevent cancer. Its strong endorsement of medical policy coverage of EsoGuard will enable more patients to benefit from esophageal precancer testing. We are committed to working with all payors to ensure that at-risk patients have broad access to EsoGuard, a critical weapon in our fight to prevent this cancer."

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 significance of the American Foregut Society's request for EsoGuard® coverage?

The AFS's request for insurance coverage of EsoGuard® is significant as it could lead to wider adoption and accessibility of the test, potentially improving early detection of esophageal precancer and prevention of esophageal cancer.

How does EsoGuard® (LUCD) differ from traditional screening methods for esophageal cancer?

EsoGuard® is a minimally invasive, DNA-based screening test that can be performed in primary care offices, offering an alternative to traditional endoscopy for detecting esophageal precancer (Barrett's Esophagus).

What potential impact could insurance coverage of EsoGuard® have on Lucid Diagnostics (LUCD)?

Insurance coverage of EsoGuard® could significantly increase the test's adoption, potentially leading to higher revenues and market penetration for Lucid Diagnostics (LUCD).

How does EsoGuard® (LUCD) address health disparities in cancer screening?

As a point-of-care test available in primary care offices, EsoGuard® can reduce health disparities by improving access to esophageal precancer screening, especially for populations with access to specialized endoscopy services.