Lucid Diagnostics Submits Clinical Evidence Package to MolDX Seeking Medicare Coverage for EsoGuard® Esophageal DNA Test
Lucid Diagnostics (LUCD) has submitted a clinical evidence package to MolDX seeking Medicare coverage for its EsoGuard® Esophageal DNA Test. The submission includes six new peer-reviewed publications, comprising three clinical validation studies, two clinical utility studies, and one analytical validation study. The package supports a Request for Reconsideration of Local Coverage Determination (LCD) L39256, aiming to secure Medicare coverage for EsoGuard testing. The company believes the data demonstrates strong clinical validity, utility, and analytical accuracy, particularly highlighting EsoGuard's precancer detection performance across all studies.
Lucid Diagnostics (LUCD) ha presentato un pacchetto di evidenze cliniche a MolDX per richiedere la copertura Medicare per il suo EsoGuard® Esophageal DNA Test. La presentazione include sei nuove pubblicazioni sottoposte a revisione paritaria, compresi tre studi di validazione clinica, due studi di utilità clinica e uno studio di validazione analitica. Il pacchetto sostiene una Richiesta di Riesame della Determinazione di Copertura Locale (LCD) L39256, con l'obiettivo di garantire la copertura Medicare per il test EsoGuard. L'azienda ritiene che i dati dimostrino una forte validità clinica, utilità e accuratezza analitica, evidenziando in particolare le prestazioni di EsoGuard nella rilevazione precoce del cancro in tutti gli studi.
Lucid Diagnostics (LUCD) ha presentado un paquete de evidencia clínica a MolDX para solicitar la cobertura de Medicare para su EsoGuard® Esophageal DNA Test. La presentación incluye seis nuevas publicaciones revisadas por pares, que comprenden tres estudios de validación clínica, dos estudios de utilidad clínica y un estudio de validación analítica. El paquete apoya una Solicitud de Reconsideración de la Determinación de Cobertura Local (LCD) L39256, con el objetivo de asegurar la cobertura de Medicare para las pruebas de EsoGuard. La empresa cree que los datos demuestran una fuerte validez clínica, utilidad y precisión analítica, destacando especialmente el rendimiento de EsoGuard en la detección precoz del cáncer en todos los estudios.
Lucid Diagnostics (LUCD)는 MolDX에 EsoGuard® 식도 DNA 검사에 대한 Medicare 보험 적용을 요청하는 임상 증거 패키지를 제출했습니다. 제출된 자료에는 세 가지 임상 검증 연구, 두 가지 임상 유용성 연구 및 하나의 분석 검증 연구를 포함한 여섯 개의 새로운 동료 검토 출판물이 포함되어 있습니다. 이 패키지는 EsoGuard 테스트에 대한 Medicare 보험 적용을 확보하기 위해 지역 커버리지 결정(LCD) L39256에 대한 재고 요청을 지원합니다. 회사는 데이터가 모든 연구에서 EsoGuard의 조기 암 발견 성능을 특히 강조해 강력한 임상 유효성, 유용성 및 분석 정확도를 입증한다고 믿고 있습니다.
Lucid Diagnostics (LUCD) a soumis un ensemble de preuves cliniques à MolDX pour demander la couverture Medicare de son EsoGuard® Test ADN œsophagien. La soumission comprend six nouvelles publications examinées par des pairs, comprenant trois études de validation clinique, deux études d'utilité clinique et une étude de validation analytique. L'ensemble soutient une Demande de Réexamen de la Détermination de Couverture Locale (LCD) L39256, visant à obtenir une couverture Medicare pour le test EsoGuard. L'entreprise estime que les données démontrent une forte validité clinique, utilité et précision analytique, mettant particulièrement en avant les performances d'EsoGuard dans la détection précoce du cancer dans toutes les études.
Lucid Diagnostics (LUCD) hat ein klinisches Evidenzpaket bei MolDX eingereicht, um eine Medicare-Abdeckung für seinen EsoGuard® Speiseröhren-DNA-Test zu beantragen. Die Einreichung umfasst sechs neue, peer-reviewed Veröffentlichungen, bestehend aus drei klinischen Validierungsstudien, zwei klinischen Nutzungsstudien und einer analytischen Validierungsstudie. Das Paket unterstützt einen Antrag auf Überprüfung der Lokalabdeckungseinstimmung (LCD) L39256, mit dem Ziel, eine Medicare-Abdeckung für den EsoGuard-Test zu sichern. Das Unternehmen ist der Ansicht, dass die Daten eine starke klinische Gültigkeit, Nützlichkeit und analytische Genauigkeit belegen, insbesondere hervorhebend die Leistung von EsoGuard bei der frühzeitigen Krebsentdeckung in allen Studien.
- Submission of complete clinical evidence package to MolDX for potential Medicare coverage expansion
- Package includes six peer-reviewed publications supporting product efficacy
- Alignment with American College of Gastroenterology (ACG) guidelines
- Current non-coverage status under Medicare limiting market access
- Pending regulatory approval with uncertain outcome
Insights
The submission of clinical evidence to MolDX marks a significant regulatory milestone for Lucid Diagnostics' EsoGuard test. The package includes six peer-reviewed publications demonstrating clinical validity, utility and analytical accuracy - important elements for Medicare coverage approval.
The data package's strength lies in its comprehensive nature, featuring three clinical validation studies, two clinical utility studies and an analytical validation study. Medicare coverage would substantially expand market access, particularly given that esophageal cancer predominantly affects older adults who are Medicare beneficiaries.
While positive coverage determination could significantly boost EsoGuard's commercial prospects, investors should note that the review process typically takes several months and approval isn't guaranteed. The alignment with ACG guidelines and MolDX criteria enhances the likelihood of a favorable outcome, but reimbursement rates and coverage terms will be critical factors to monitor.
"This submission is the culmination of many years of persistent hard work by our team and our many clinical research partners, and represents perhaps the most important milestone in Lucid's history," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "We believe the data in this package strongly supports EsoGuard's clinical validity, utility, and analytical accuracy, aligning with the MolDX criteria for coverage as outlined in the LCD. The clinical validity data, in particular, demonstrates EsoGuard's unprecedented precancer detection performance across all studies. We look forward to the opportunity to expand access to EsoGuard precancer testing to all at-risk Medicare beneficiaries."
The EsoGuard clinical evidence package includes six new peer-reviewed publications: three clinical validation studies (two in the intended use population, one case control), two clinical utility studies, and one analytical validation study. The current LCD provides clear coverage criteria consistent with the American College of Gastroenterology (ACG) guidelines for esophageal precancer testing. The package was submitted as part of a request for reconsideration of the non-coverage language in the LCD to secure Medicare coverage for EsoGuard.
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 purpose of Lucid Diagnostics' (LUCD) clinical evidence package submission to MolDX?
How many studies were included in Lucid Diagnostics' (LUCD) clinical evidence package?
What is EsoGuard's current Medicare coverage status for LUCD?
