Lucid Diagnostics Announces Positive Data from ENVET-BE Clinical Utility Study of EsoGuard® Esophageal Precancer Testing
Lucid Diagnostics (Nasdaq: LUCD) has released new real-world data from its ENVET-BE study, demonstrating the clinical utility of the EsoGuard® Esophageal DNA test as a non-invasive triage tool for detecting esophageal precancer and cancer. The study showed that patients triaged to invasive upper endoscopy (EGD) following a positive EsoGuard test had a 2.4-fold increase in positive yield compared to screening EGD alone in at-risk patients.
Key findings include:
- EGD confirmed Barrett's Esophagus (BE) in 50 out of 199 patients who received a positive EsoGuard result
- Post-triage EGD yield was 25%, compared to the expected 11% yield of EGD as a standalone screening tool
- Results support the use of EsoGuard as an alternative to EGD for esophageal precancer testing, potentially increasing compliance with screening guidelines and reducing esophageal cancer deaths
Lucid Diagnostics (Nasdaq: LUCD) ha rilasciato nuovi dati del mondo reale dallo studio ENVET-BE, dimostrando l'utilità clinica del test del DNA EsoGuard® come strumento di triage non invasivo per la rilevazione di precancerosi e cancro esofageo. Lo studio ha mostrato che i pazienti sottoposti a triage per una endoscopia superiore invasiva (EGD) dopo un test EsoGuard positivo hanno avuto un aumento della resa positiva di 2,4 volte rispetto all'EGD di screening da solo nei pazienti a rischio.
I risultati chiave includono:
- L'EGD ha confermato l'esofago di Barrett (BE) in 50 su 199 pazienti che hanno ricevuto un risultato positivo da EsoGuard
- La resa dell'EGD post-triage è stata del 25%, rispetto all'11% previsto dall'EGD come strumento di screening autonomo
- I risultati supportano l'uso di EsoGuard come alternativa all'EGD per il test di precancerosi esofagei, aumentando potenzialmente la compliance con le linee guida per lo screening e riducendo le morti per cancro esofageo
Lucid Diagnostics (Nasdaq: LUCD) ha publicado nuevos datos del mundo real de su estudio ENVET-BE, que demuestran la utilidad clínica de la prueba de ADN EsoGuard® como herramienta de triaje no invasiva para detectar precáncer y cáncer esofágico. El estudio mostró que los pacientes sometidos a triaje para una endoscopia superior invasiva (EGD) tras un resultado positivo de EsoGuard tuvieron un aumento de 2.4 veces en el rendimiento positivo en comparación con la EGD de detección por sí sola en pacientes en riesgo.
Los hallazgos clave incluyen:
- La EGD confirmó esófago de Barrett (BE) en 50 de 199 pacientes que recibieron un resultado positivo de EsoGuard
- El rendimiento de la EGD tras el triaje fue del 25%, en comparación con el 11% esperado de la EGD como herramienta de detección independiente
- Los resultados apoyan el uso de EsoGuard como una alternativa a la EGD para las pruebas de precáncer esofágico, lo que podría aumentar la adherencia a las pautas de detección y reducir las muertes por cáncer esofágico
루시드 다이아그노스틱스(Lucid Diagnostics, Nasdaq: LUCD)는 비침습적인 선별 도구로서 식도 전암 및 암을 발견하는 데 있어 EsoGuard® 식도 DNA 테스트의 임상 유용성을 입증한 ENVET-BE 연구의 새로운 실제 데이터를 발표했습니다. 연구에서 EsoGuard 테스트에서 양성 결과를 받은 후 침습적인 상부 위장관 내시경 검사(EGD)로 분류된 환자들은 위험군 환자의 단독 스크리닝 EGD와 비교하여 양성 수율이 2.4배 증가했음을 보여주었습니다.
주요 발견사항은 다음과 같습니다:
- EGD는 EsoGuard에서 양성 결과를 받은 199명의 환자 중 50명의 바렛 식도(BE)를 확인했습니다.
- 분류 후 EGD 수율은 25%로, 단독 스크리닝 도구로서의 EGD에서 기대되는 11% 수율과 비교되었습니다.
- 결과는 EsoGuard가 식도 전암 테스트를 위한 EGD의 대안으로 사용될 수 있음을 지지하며, 이는 스크리닝 가이드라인 준수를 증가시키고 식도암 사망을 줄이는 데 기여할 수 있습니다.
Lucid Diagnostics (Nasdaq : LUCD) a publié de nouvelles données réelles issues de son étude ENVET-BE, démontrant l'utilité clinique du test ADN EsoGuard® en tant qu'outil de tri non invasif pour détecter les précancers et cancers de l'œsophage. L'étude a montré que les patients triés pour une endoscopie supérieure invasive (EGD) après un test EsoGuard positif avaient un augmentation de 2,4 fois du rendement positif comparativement à l'EGD de dépistage seul chez les patients à risque.
Les principaux résultats incluent :
- L'EGD a confirmé un œsophage de Barrett (BE) chez 50 des 199 patients ayant reçu un résultat positif d'EsoGuard
- Le rendement de l'EGD après triage était de 25 %, comparé au rendement prévu de 11 % de l'EGD en tant qu'outil de dépistage autonome
- Les résultats soutiennent l'utilisation d'EsoGuard comme alternative à l'EGD pour le test de précancer de l'œsophage, augmentant potentiellement l'adhésion aux directives de dépistage et réduisant les décès par cancer de l'œsophage
Lucid Diagnostics (Nasdaq: LUCD) hat neue reale Daten aus der ENVET-BE-Studie veröffentlicht, die die klinische Nützlichkeit des EsoGuard® Esophageal DNA Tests als nicht-invasives Triage-Tool zur Erkennung von speiseröhrenpräkanzerösen Erkrankungen und Krebs demonstrieren. Die Studie zeigte, dass Patienten, die nach einem positiven EsoGuard-Test zu einer invasiven oberen Endoskopie (EGD) eingestuft wurden, eine 2,4-fache Steigerung der Positiven Ausbeute im Vergleich zur EGD-Screening allein bei gefährdeten Patienten aufwiesen.
Wichtige Ergebnisse sind:
- Die EGD bestätigte Barretts Ösophagus (BE) bei 50 von 199 Patienten, die ein positives EsoGuard-Ergebnis erhalten hatten
- Die Ausbeute der EGD nach der Triage betrug 25%, im Vergleich zur erwarteten Ausbeute von 11% für die EGD als eigenständiges Screening-Tool
- Die Ergebnisse unterstützen die Verwendung von EsoGuard als Alternative zur EGD für Tests auf speiseröhrenpräkanzeröse Erkrankungen, was potenziell die Compliance mit Screening-Richtlinien erhöht und die Sterblichkeit durch Speiseröhrenkrebs reduziert
- EsoGuard test demonstrated a 2.4-fold increase in positive yield for detecting esophageal precancer compared to standard screening
- 25% post-triage EGD yield, significantly higher than the expected 11% yield of EGD alone
- Results support the use of EsoGuard as a non-invasive alternative to EGD for esophageal precancer testing
- Potential to increase compliance with esophageal precancer screening guidelines
- None.
Insights
The ENVET-BE study results are highly promising for Lucid Diagnostics' EsoGuard® test. The 2.4-fold increase in positive yield for detecting Barrett's Esophagus (BE) is significant. This efficiency boost could lead to:
- Improved resource allocation in endoscopy units
- Earlier detection of esophageal precancer
- Potentially reduced healthcare costs
However, it's important to note that while the
This data is encouraging for esophageal cancer prevention. The
The non-invasive nature of EsoGuard may increase screening compliance, potentially leading to earlier interventions. However, we must be cautious about over-reliance on a single screening tool. The
Lucid Diagnostics' EsoGuard® test shows strong market potential. The
Key market drivers include:
- Alignment with professional guidelines
- Potential for increased screening compliance
- Improved efficiency in detecting esophageal precancer
However, market penetration may face challenges such as insurance coverage and competition from other non-invasive screening methods. The test's
Real-world data confirms utility of EsoGuard as a non-invasive triage tool to significantly increase positive yield of invasive upper endoscopy
"Up to
EGD confirmed a BE diagnosis in 50 of the 199 patients in a real-world commercial setting who underwent clinically directed EsoGuard testing and received a positive EsoGuard result. This represents a post-triage EGD yield of
"The ENVET-BE study demonstrates that triaging at-risk patients with EsoGuard significantly increases the yield of EGD, which should lead to more efficient use of endoscopy resources while improving early detection of esophageal precancer," said Victoria T. Lee, M.D., Lucid's Chief Medical Officer. "These results support published professional society guidelines which include non-endoscopic biomarker tests, such as EsoGuard, as an acceptable alternative to EGD for esophageal precancer testing. Using EsoGuard to triage patients to EGD has the potential to increase compliance with esophageal precancer screening guidelines and reduce esophageal cancer deaths."
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 ENVET-BE study conducted by Lucid Diagnostics (LUCD)?
How much did EsoGuard improve the detection rate of Barrett's Esophagus in the ENVET-BE study?
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How many patients in the ENVET-BE study were confirmed to have Barrett's Esophagus after a positive EsoGuard test?
