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

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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.

La American Foregut Society (AFS) ha formalmente richiesto ai fornitori di assicurazioni sanitarie di aggiornare le loro politiche mediche per includere il test del DNA esofageo EsoGuard® di Lucid Diagnostics (Nasdaq: LUCD) come servizio coperto. Questa iniziativa mira a migliorare la diagnosi precoce del precancro esofageo (Esofago di Barrett) e a prevenire il cancro esofageo altamente letale. L'AFS, una delle principali società di gastroenterologi e chirurghi, ha evidenziato le forti evidenze scientifiche a supporto di EsoGuard come un'alternativa di screening minimamente invasiva all'endoscopia.

L'AFS ha sottolineato che espandere l'accesso a EsoGuard darà ai fornitori uno strumento di triage essenziale per l'endoscopia superiore, consentendo una diagnosi precoce dell'Esofago di Barrett. Essendo un test effettuabile presso i medici di famiglia, EsoGuard può ridurre le disparità nella disponibilità di endoscopie. La società ha sollecitato una copertura immediata del test, in linea con le recenti linee guida delle società di gastroenterologia e con la legislazione statale che impone la copertura di test biomarcatori simili.

La American Foregut Society (AFS) ha solicitado formalmente a los proveedores de seguros de salud que actualicen sus políticas médicas para incluir el test de ADN esofágico EsoGuard® de Lucid Diagnostics (Nasdaq: LUCD) como un servicio cubierto. Este movimiento tiene como objetivo mejorar la detección temprana del cáncer precoces esofágicos (esófago de Barrett) y prevenir el cáncer esofágico altamente letal. La AFS, una destacada sociedad de gastroenterólogos y cirujanos, subrayó las fuertes evidencias científicas que respaldan a EsoGuard como una alternativa de screening mínimamente invasiva a la endoscopia.

La AFS enfatizó que la expansión del acceso a EsoGuard empoderará a los proveedores con un triaje esencial para la endoscopia superior, permitiendo la detección temprana del esófago de Barrett. Como test en el punto de atención en consultorios de atención primaria, EsoGuard puede reducir las disparidades en el acceso a la endoscopia. La sociedad instó a la cobertura inmediata del test, alineándose con las recientes guías de sociedades de gastroenterología y la legislación estatal que exige la cobertura de tales pruebas de biomarcadores.

미국 전방위 소화기학회(AFS)는 보험 제공자에게 루시드 다이애그노스틱스(Lucid Diagnostics)(Nasdaq: LUCD)의 EsoGuard® 식도 DNA 검사를 보장 서비스로 포함하라는 공식 요청을 했습니다. 이 조치는 식도 초기 암(바렛 식도)의 조기 발견을 강화하고 매우 치명적인 식도암을 예방할 것을 목표로 하고 있습니다. AFS는 주요 위장병학자 및 외과 의사 협회로서 EsoGuard를 지원하는 강력한 과학적 증거를 강조하며, 내시경에 대한 최소 침습적 스크리닝 대안으로 제시했습니다.

AFS는 EsoGuard에 대한 접근을 확장하는 것이 상부 내시경에 대한 필수적 선별 권한을 제공하여 바렛 식도의 조기 발견을 가능하게 한다고 강조했습니다. EsoGuard는 1차 진료 사무실에서 사용할 수 있는 포인터케어 테스트로, 내시경 접근의 건강 불평등을 줄일 수 있습니다. 협회는 최근 위장병학회 가이드라인과 생체 표지자 검사에 대한 보장을 의무화하는 주 법안과 일치하여 즉각적인 검사 보장을 촉구했습니다.

La American Foregut Society (AFS) a officiellement demandé aux fournisseurs d'assurances santé de mettre à jour leurs politiques médicales afin d'inclure le test ADN œsophagien EsoGuard® de Lucid Diagnostics (Nasdaq: LUCD) comme service couvert. Cette initiative vise à améliorer la détection précoce des lésions précoces de l'œsophage (œsophage de Barrett) et à prévenir le cancer œsophagien hautement létal. L'AFS, société de gastro-entérologues et de chirurgiens, a mis en avant les fortes preuves scientifiques soutenant EsoGuard comme une alternative de dépistage peu invasive par rapport à l'endoscopie.

L'AFS a souligné que l'élargissement de l'accès à EsoGuard permettra aux prestataires de disposer d'un outil de triage essentiel pour l'endoscopie supérieure, favorisant la détection précoce de l'œsophage de Barrett. En tant que test au point de soin dans les cabinets de médecine générale, EsoGuard peut réduire les disparités en matière d'accès à l'endoscopie. La société a appelé à une couverture immédiate du test, en accord avec les récentes directives des sociétés de gastro-entérologie et la législation étatique obligeant à couvrir ce type de tests biomarqueurs.

Die American Foregut Society (AFS) hat formell die Anbieter von Krankenversicherungen gebeten, ihre medizinischen Richtlinien zu aktualisieren, um den Esofagus-DNA-Test EsoGuard® von Lucid Diagnostics (Nasdaq: LUCD) als gedeckte Leistung aufzunehmen. Dieser Schritt zielt darauf ab, die frühzeitige Erkennung von speiseröhrenvorstufen (Barrett-Ösophagus) zu verbessern und den hochgradig tödlichen Speiseröhrenkrebs zu verhindern. Die AFS, eine führende Gesellschaft für Gastroenterologen und Chirurgen, betonte die starken wissenschaftlichen Beweise, die EsoGuard unterstützen als eine minimalinvasive Screening-Alternative zur Endoskopie.

Die AFS betonte, dass der erweiterte Zugang zu EsoGuard den Anbietern ein wesentliches Triage-Werkzeug für die obere Endoskopie ermöglichen wird, wodurch die frühzeitige Erkennung des Barrett-Ösophagus gefördert wird. Als Point-of-Care-Test in Hausarztpraxen kann EsoGuard gesundheitliche Ungleichheiten im Zugang zur Endoskopie reduzieren. Die Gesellschaft forderte eine sofortige Übernahme der Kosten für den Test und stimmte mit den aktuellen Richtlinien der Gastroenterologiegesellschaften und der staatlichen Gesetzgebung, die die Abdeckung von Biomarker-Tests vorschreibt, überein.

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

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.

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.

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