Lucid Diagnostics' ENVET-BE Clinical Utility Study of EsoGuard® Esophageal Precancer Testing Accepted for Peer-Reviewed Publication
Lucid Diagnostics (Nasdaq: LUCD) announced the acceptance of its ENVET-BE clinical utility study for publication in Gastroenterology & Hepatology, marking the fifth peer-reviewed publication supporting its EsoGuard® Esophageal DNA Test.
The study, examining data from 199 EsoGuard-positive patients who underwent confirmatory upper endoscopy (EGD), demonstrated that EsoGuard significantly improves the detection of esophageal precancer (Barrett's Esophagus or BE). Key findings show:
- 2.4-fold higher diagnostic yield for BE compared to screening EGD alone
- Nearly three-fold higher yield in patients meeting American College of Gastroenterology screening criteria
This research validates EsoGuard as an effective non-invasive triage tool, allowing most at-risk patients to avoid invasive procedures while enhancing the efficiency of endoscopy resource utilization. The study supports ongoing efforts to secure positive commercial insurance coverage policies, following recent success with Highmark Blue Cross Blue Shield.
Lucid Diagnostics (Nasdaq: LUCD) ha annunciato l'accettazione del suo studio sulla utilità clinica ENVET-BE per la pubblicazione su Gastroenterology & Hepatology, segnando la quinta pubblicazione sottoposta a revisione paritaria a supporto del suo EsoGuard® Esophageal DNA Test.
Lo studio, che ha esaminato i dati di 199 pazienti positivi a EsoGuard che hanno subito una endoscopia gastrointestinale superiore (EGD) di conferma, ha dimostrato che EsoGuard migliora significativamente la rilevazione del precancro esofageo (Esofago di Barrett o BE). I risultati chiave mostrano:
- un rendimento diagnostico 2,4 volte superiore per BE rispetto all'EGD di screening da solo
- un rendimento quasi tre volte superiore nei pazienti che soddisfano i criteri di screening dell'American College of Gastroenterology
Questa ricerca convalida EsoGuard come uno strumento di triage non invasivo efficace, consentendo alla maggior parte dei pazienti a rischio di evitare procedure invasive, migliorando al contempo l'efficienza nell'utilizzo delle risorse di endoscopia. Lo studio supporta gli sforzi in corso per garantire politiche di copertura assicurativa commerciale positive, dopo il recente successo con Highmark Blue Cross Blue Shield.
Lucid Diagnostics (Nasdaq: LUCD) anunció la aceptación de su estudio de utilidad clínica ENVET-BE para publicación en Gastroenterology & Hepatology, marcando la quinta publicación revisada por pares que respalda su EsoGuard® Esophageal DNA Test.
El estudio, que examinó datos de 199 pacientes positivos para EsoGuard que se sometieron a una endoscopia superior (EGD) de confirmación, demostró que EsoGuard mejora significativamente la detección del precáncer esofágico (Esofago de Barrett o BE). Los hallazgos clave muestran:
- un rendimiento diagnóstico 2.4 veces mayor para BE en comparación con la EGD de detección sola
- casi tres veces mayor rendimiento en pacientes que cumplen con los criterios de detección del American College of Gastroenterology
Esta investigación valida a EsoGuard como una herramienta de triaje no invasiva efectiva, permitiendo que la mayoría de los pacientes en riesgo eviten procedimientos invasivos, al tiempo que mejora la eficiencia en la utilización de recursos de endoscopia. El estudio apoya los esfuerzos en curso para asegurar políticas de cobertura de seguros comerciales positivas, tras el reciente éxito con Highmark Blue Cross Blue Shield.
Lucid Diagnostics (Nasdaq: LUCD)는 EsoGuard® 식도 DNA 검사를 지원하는 다섯 번째 동료 검토 출판물인 ENVET-BE 임상 유용성 연구의 게재 수락을 발표했습니다. 이 연구는 Gastroenterology & Hepatology에 게재될 예정입니다.
이 연구는 확인을 위해 상부 내시경(EGD)을 받은 199명의 EsoGuard 양성 환자 데이터를 조사했으며, EsoGuard가 식도 전암(바렛 식도 또는 BE)의 발견을 크게 향상시킨다는 것을 보여주었습니다. 주요 발견 사항은 다음과 같습니다:
- 단독 스크리닝 EGD에 비해 BE에 대한 진단 수확률이 2.4배 증가
- 미국 소화기학회 스크리닝 기준을 충족하는 환자에서 거의 3배 높은 수확률
이 연구는 EsoGuard를 효과적인 비침습적 분류 도구로 검증하여 대부분의 고위험 환자가 침습적 절차를 피할 수 있도록 하며, 내시경 자원 활용의 효율성을 높입니다. 이 연구는 최근 Highmark Blue Cross Blue Shield와의 성공 이후 긍정적인 상업 보험 보장 정책을 확보하기 위한 지속적인 노력을 지원합니다.
Lucid Diagnostics (Nasdaq: LUCD) a annoncé l'acceptation de son étude sur l'utilité clinique ENVET-BE pour publication dans Gastroenterology & Hepatology, marquant la cinquième publication évaluée par des pairs soutenant son EsoGuard® Test ADN œsophagien.
L'étude, qui a examiné les données de 199 patients positifs à EsoGuard ayant subi une endoscopie supérieure (EGD) de confirmation, a démontré qu'EsoGuard améliore significativement la détection des précancers œsophagiens (œsophage de Barrett ou BE). Les principales conclusions montrent :
- un rendement diagnostique 2,4 fois supérieur pour le BE par rapport à l'EGD de dépistage seul
- un rendement presque trois fois supérieur chez les patients répondant aux critères de dépistage du American College of Gastroenterology
Cette recherche valide EsoGuard comme un outil de triage non invasif efficace, permettant à la plupart des patients à risque d'éviter des procédures invasives tout en améliorant l'efficacité de l'utilisation des ressources en endoscopie. L'étude soutient les efforts en cours pour obtenir des politiques de couverture d'assurance commerciale positives, suite au récent succès avec Highmark Blue Cross Blue Shield.
Lucid Diagnostics (Nasdaq: LUCD) gab die Annahme seiner klinischen Nutzungsstudie ENVET-BE zur Veröffentlichung in Gastroenterology & Hepatology bekannt, was die fünfte von Fachkollegen geprüfte Veröffentlichung zur Unterstützung seines EsoGuard® Speiseröhren-DNA-Tests darstellt.
Die Studie, die Daten von 199 EsoGuard-positiven Patienten untersuchte, die sich einer bestätigenden oberen Endoskopie (EGD) unterzogen, zeigte, dass EsoGuard die Erkennung von Speiseröhren-Vorläuferkrebs (Barrett-Ösophagus oder BE) erheblich verbessert. Wichtige Ergebnisse zeigen:
- 2,4-fach höherer diagnostischer Ertrag für BE im Vergleich zur alleinigen Screening-EGD
- Fast dreifach höherer Ertrag bei Patienten, die die Screening-Kriterien des American College of Gastroenterology erfüllen
Diese Forschung validiert EsoGuard als effektives nicht-invasives Triage-Werkzeug, das es den meisten Risikopatienten ermöglicht, invasive Verfahren zu vermeiden, während die Effizienz der Endoskopie-Ressourcennutzung verbessert wird. Die Studie unterstützt die laufenden Bemühungen, positive kommerzielle Versicherungsdeckungsrichtlinien zu sichern, nach dem jüngsten Erfolg mit Highmark Blue Cross Blue Shield.
- Fifth peer-reviewed publication validates EsoGuard's clinical utility
- 2.4x higher diagnostic yield compared to standard screening
- Recent success in securing Highmark Blue Cross Blue Shield coverage
- Strong clinical evidence supporting insurance coverage expansion
- None.
Insights
Lucid Diagnostics' ENVET-BE clinical utility study publication represents a significant advancement in validating its EsoGuard Esophageal DNA Test as an effective screening tool for Barrett's Esophagus (BE), a precancerous condition that can lead to esophageal cancer.
The study's results are compelling from both clinical and commercial perspectives. Data from 199 EsoGuard-positive patients demonstrated that follow-up endoscopies yielded 2.4 times more BE diagnoses than expected with standard screening approaches, increasing to nearly 3-fold higher in patients meeting established screening criteria. This demonstrates EsoGuard's effectiveness as a non-invasive triage tool that can identify which patients truly need invasive endoscopy procedures.
From a healthcare economics standpoint, this validation is particularly valuable. By effectively triaging patients, EsoGuard addresses two critical challenges in esophageal precancer detection: low compliance with screening recommendations and inefficient use of endoscopy resources. The ability to reserve invasive procedures for higher-risk patients creates a compelling value proposition for healthcare systems and payers.
This publication – the fifth peer-reviewed validation of EsoGuard's clinical utility – strengthens Lucid's position in ongoing discussions with commercial insurers. The company has already secured positive coverage with Highmark Blue Cross Blue Shield, suggesting momentum in payer adoption. Expanded insurance coverage would significantly accelerate commercial uptake and accessibility.
For Lucid, this clinical validation milestone represents a important step toward broader market adoption and revenue growth. As esophageal cancer rates continue rising, particularly in patients with chronic acid reflux, effective early detection tools with strong clinical evidence are positioned for significant market penetration.
Study confirms clinical utility of EsoGuard as a non-invasive triage tool to significantly increase positive yield of invasive upper endoscopy
"This study cements EsoGuard's critical role as a non-invasive tool to triage at-risk patients to invasive EGD, allowing the vast majority of patients recommended for esophageal precancer testing to avoid an invasive procedure. This is precisely what non-invasive triage tests are designed to do," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "The study further strengthens EsoGuard's already robust clinical evidence base. We previously demonstrated near perfect concordance between EsoGuard results and physician referral for EGD as well as excellent patient compliance with EGD referral and now document increased EGD diagnostic yield with EsoGuard testing. This comprehensive clinical utility data package supports our ongoing efforts to secure positive commercial insurance coverage policies, building on our recent success with Highmark Blue Cross Blue Shield. The study strongly supports EsoGuard's economic value by demonstrating its potential to increase compliance with BE screening guidelines while promoting more efficient use of more costly endoscopy resources."
The ENVET-BE study reviewed real-world data from a cohort of 199 EsoGuard-positive patients who completed confirmatory EGD. The overall positive diagnostic yield for BE was 2.4-fold higher than the expected yield of screening EGD alone, based on disease prevalence within an at-risk population. The yield was nearly three-fold higher in patients meeting American College of Gastroenterology (ACG) screening criteria. The study authors concluded that "EsoGuard enriches the population undergoing EGD and, compared to a screening strategy that relies on EGD alone, it improves overall diagnostic yield. This could potentially help direct more efficient use of endoscopy resources while improving BE detection in at-risk patients."
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
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