Lucid Diagnostics' ESOGUARD BE-1 Prospective Multicenter Clinical Validation Study of EsoGuard® Esophageal Precancer Testing Accepted for Peer-Reviewed Publication
Lucid Diagnostics (NASDAQ: LUCD) announced the acceptance of its ESOGUARD BE-1 study manuscript for publication in The American Journal of Gastroenterology. The study, led by Dr. Nicholas J. Shaheen, validates the EsoGuard® Esophageal DNA Test performance in detecting esophageal precancer. The test demonstrated approximately 88% sensitivity and 99% negative predictive value, with 81% specificity and 30% positive predictive value. This fourth clinical validation publication completes Lucid's evidence package for Medicare coverage submission. The multicenter study was conducted across leading U.S. and European medical centers, showing strong performance in screening populations with no serious adverse events reported.
Lucid Diagnostics (NASDAQ: LUCD) ha annunciato l'accettazione del manoscritto dello studio ESOGUARD BE-1 per la pubblicazione sull'American Journal of Gastroenterology. Lo studio, guidato dal Dr. Nicholas J. Shaheen, convalida le prestazioni del EsoGuard® Esophageal DNA Test nella rilevazione del precancro esofageo. Il test ha mostrato circa un 88% di sensibilità e un 99% di valore predittivo negativo, con un 81% di specificità e un 30% di valore predittivo positivo. Questa quarta pubblicazione di validazione clinica completa il pacchetto di prove di Lucid per la richiesta di copertura Medicare. Lo studio multicentrico è stato condotto in importanti centri medici negli Stati Uniti e in Europa, mostrando elevate prestazioni nella popolazione di screening senza eventi avversi gravi riportati.
Lucid Diagnostics (NASDAQ: LUCD) anunció la aceptación de su manuscrito del estudio ESOGUARD BE-1 para su publicación en The American Journal of Gastroenterology. El estudio, dirigido por el Dr. Nicholas J. Shaheen, valida el rendimiento de la EsoGuard® Esophageal DNA Test en la detección del precáncer esofágico. La prueba demostró aproximadamente un 88% de sensibilidad y un 99% de valor predictivo negativo, con un 81% de especificidad y un 30% de valor predictivo positivo. Esta cuarta publicación de validación clínica completa el paquete de evidencia de Lucid para la solicitud de cobertura de Medicare. El estudio multicéntrico se llevó a cabo en importantes centros médicos de EE.UU. y Europa, mostrando un fuerte rendimiento en las poblaciones de detección sin reportar eventos adversos graves.
루시드 진단(Lucid Diagnostics) (NASDAQ: LUCD)는 ESOGUARD BE-1 연구 원고가 미국 소화기학 저널에 게재 승인을 받았다고 발표했다. 닉 샤힌(Nicholas J. Shaheen) 박사가 이끄는 이 연구는 EsoGuard® 식도 DNA 테스트의 식도 전암 감지 성능을 검증했다. 이 테스트는 약 88%의 민감도와 99%의 음성 예측 값, 81%의 특이도 및 30%의 양성 예측 값을 나타냈다. 이 네 번째 임상 검증 출판물은 Medicare 보장 요청을 위한 루시드의 증거 패키지를 완성한다. 이 다기관 연구는 미국 및 유럽의 주요 의료 센터에서 수행되었으며, 심각한 부작용 없이 스크리닝 인구에서 강력한 성과를 보였다.
Lucid Diagnostics (NASDAQ: LUCD) a annoncé l'acceptation de son manuscrit de l'étude ESOGUARD BE-1 pour publication dans The American Journal of Gastroenterology. L'étude, dirigée par le Dr. Nicholas J. Shaheen, valide les performances du EsoGuard® Esophageal DNA Test dans la détection des précancers œsophagiens. Le test a démontré environ 88% de sensibilité et 99% de valeur prédictive négative, avec 81% de spécificité et 30% de valeur prédictive positive. Cette quatrième publication de validation clinique complète le dossier de preuves de Lucid pour la demande de couverture Medicare. L'étude multicentrique a été réalisée dans des centres médicaux de premier plan aux États-Unis et en Europe, montrant de solides performances dans les populations de dépistage sans événements indésirables graves rapportés.
Lucid Diagnostics (NASDAQ: LUCD) gab die Annahme des Manuskripts der ESOGUARD BE-1 Studie zur Veröffentlichung im The American Journal of Gastroenterology bekannt. Die Studie, geleitet von Dr. Nicholas J. Shaheen, validiert die Leistung des EsoGuard® Esophageal DNA Tests zur Erkennung von ösophagealen Präkanzerosen. Der Test zeigte eine Empfindlichkeit von etwa 88% und einen negativen prädiktiven Wert von 99%, bei einer Spezifität von 81% und einem positiven prädiktiven Wert von 30%. Diese vierte klinische Validierungspublikation vervollständigt Lucids Evidenzpaket für die Medicare-Abdeckung. Die multizentrische Studie wurde in führenden medizinischen Zentren in den USA und Europa durchgeführt und zeigte eine starke Leistung in der Screening-Population ohne berichtete schwerwiegende unerwünschte Ereignisse.
- High test performance metrics with 88% sensitivity and 99% negative predictive value
- Acceptance in a prestigious peer-reviewed journal strengthens clinical credibility
- Completion of clinical evidence package for Medicare coverage submission
- No serious adverse events reported in the study
- Relatively low positive predictive value at 30%
Insights
The acceptance of ESOGUARD BE-1 study for publication represents a significant clinical milestone for Lucid Diagnostics. The study's results are particularly compelling, showing
This fourth validation study completes the clinical evidence package required for Medicare coverage submission through the MolDX program. The multi-center nature of the study, involving prestigious institutions and following ACG guideline criteria, strengthens its credibility. The high negative predictive value is especially important as it indicates strong reliability in ruling out disease, potentially reducing unnecessary endoscopies.
For investors, the completion of the clinical evidence package could accelerate the path to Medicare coverage, potentially expanding market access and revenue opportunities. The strong performance metrics and safety profile position EsoGuard favorably against traditional screening methods.
Publication, which once again demonstrates strong EsoGuard performance in a screening population, completes Lucid's clinical evidence package for submission to formally seek Medicare coverage
"The publication of the ESOGUARD BE-1 study, which once again demonstrated unprecedented EsoGuard performance, is a major milestone for Lucid," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "With this fourth clinical validation study accepted for peer-reviewed publication, we believe we now have a complete clinical evidence package to submit our data to the MolDX program and formally seek Medicare coverage. We are deeply grateful to Dr. Shaheen and the other investigators, across two continents, for their hard work and commitment to esophageal cancer prevention."
The manuscript, entitled Use of the EsoGuard® Molecular Biomarker Test in Non-Endoscopic Detection of Barrett's Esophagus among High-Risk Individuals in a Screening Population, follows manuscripts from two other EsoGuard clinical validation studies, the
The principal investigator of the ESOGUARD BE-1 study and lead author of the manuscript was leading esophageal precancer expert Nicholas J. Shaheen, M.D., M.P.H., the Bozymski-Heizer Distinguished Professor of Medicine and Epidemiology at the University of North Carolina School of Medicine, and lead author of the ACG guidelines on esophageal precancer screening. Study sites included leading academic medical centers, such as Baylor College of Medicine, University of California-Irvine, Vanderbilt University, and University of
The prospective, multicenter study presented data from a cohort of patients who met ACG guideline criteria for esophageal precancer screening and underwent non-endoscopic EsoGuard testing followed by traditional upper endoscopy. EsoGuard sensitivity and negative predictive value for detecting BE were approximately
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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