Prospective Clinical Utility Study of Lucid Diagnostics' EsoGuard® Esophageal DNA Test Accepted for Peer-Reviewed Publication
Lucid Diagnostics (NASDAQ: LUCD) announced the acceptance of its CLUE study manuscript for publication in Medicina, marking the fourth peer-reviewed publication supporting EsoGuard's clinical utility. The study demonstrated exceptional results, including 85% patient compliance with referral to confirmatory upper endoscopy following EsoGuard testing.
The prospective, multicenter study enrolled 502 patients across eight clinical centers, showing strong provider decision impact: 100% of EsoGuard-positive patients were referred for confirmatory EGD, while over 99% of EsoGuard-negative patients were not referred. The compliance rate was more than double the typical screening EGD referral rate in published literature.
Lucid Diagnostics (NASDAQ: LUCD) ha annunciato l'accettazione del manoscritto del suo studio CLUE per la pubblicazione su Medicina, segnando la quarta pubblicazione sottoposta a revisione paritaria che supporta l'utilità clinica di EsoGuard. Lo studio ha dimostrato risultati eccezionali, tra cui un 85% di conformità dei pazienti con il rinvio a una endoscopia superiore di conferma dopo il test EsoGuard.
Lo studio prospettico, multicentrico ha arruolato 502 pazienti in otto centri clinici, mostrando un forte impatto sulle decisioni dei fornitori: il 100% dei pazienti positivi a EsoGuard è stato rinviato per una EGD di conferma, mentre oltre il 99% dei pazienti negativi a EsoGuard non è stato rinviato. Il tasso di conformità è stato più del doppio rispetto al tasso tipico di rinvio per EGD per screening riportato nella letteratura pubblicata.
Lucid Diagnostics (NASDAQ: LUCD) anunció la aceptación de su manuscrito del estudio CLUE para su publicación en Medicina, marcando la cuarta publicación revisada por pares que respalda la utilidad clínica de EsoGuard. El estudio demostró resultados excepcionales, incluyendo 85% de cumplimiento de los pacientes con la derivación a una endoscopia superior confirmatoria tras la prueba de EsoGuard.
El estudio prospectivo y multicéntrico incluyó a 502 pacientes en ocho centros clínicos, mostrando un fuerte impacto en la decisión de los proveedores: el 100% de los pacientes positivos en EsoGuard fue referido para EGD confirmatoria, mientras que más de el 99% de los pacientes negativos en EsoGuard no fueron referidos. La tasa de cumplimiento fue más del doble de la tasa típica de derivación para EGD en la literatura publicada.
Lucid Diagnostics (NASDAQ: LUCD)는 Medicina에 CLUE 연구 원고의 출판이 수락되었음을 발표했으며, 이는 EsoGuard의 임상 효용을 지원하는 네 번째 동료 검토 출판물입니다. 이 연구는 뛰어난 결과를 보여주었으며, EsoGuard 테스트 후 확인을 위한 상부 내시경 검사 의뢰에 85%의 환자 순응도를 보였습니다.
이 전망적 다기관 연구는 8개의 임상 센터에서 502명의 환자를 모집하였으며, 제공자의 결정에 강한 영향을 미쳤습니다: EsoGuard 양성 환자의 100%가 확인 EGD로 의뢰되었고, EsoGuard 음성 환자의 99% 이상은 의뢰되지 않았습니다. 순응도 비율은 발표된 문헌의 전형적인 스크리닝 EGD 의뢰 비율의 두 배 이상이었습니다.
Lucid Diagnostics (NASDAQ: LUCD) a annoncé l'acceptation de son manuscrit d'étude CLUE pour publication dans Medicina, marquant la quatrième publication à comité de lecture soutenant l'utilité clinique d'EsoGuard. L'étude a démontré des résultats exceptionnels, y compris 85 % de conformité des patients avec la référence à une endoscopie supérieure confirmatoire après le test EsoGuard.
Cette étude prospective multicentrique a recruté 502 patients à travers huit centres cliniques, montrant un impact fort sur les décisions des fournisseurs : 100 % des patients positifs au EsoGuard ont été référés pour une EGD confirmatoire, tandis que plus de 99 % des patients négatifs au EsoGuard n'ont pas été référés. Le taux de conformité était plus de deux fois supérieur au taux de référence typique de l'EGD de dépistage dans la littérature publiée.
Lucid Diagnostics (NASDAQ: LUCD) gab die Akzeptanz seines CLUE-Studienmanuskripts zur Veröffentlichung in Medicina bekannt, was die vierte begutachtete Veröffentlichung zur Unterstützung der klinischen Nützlichkeit von EsoGuard kennzeichnet. Die Studie zeigte außergewöhnliche Ergebnisse, darunter eine 85%ige Patientencompliance mit der Überweisung zur bestätigenden oberen Endoskopie nach EsoGuard-Tests.
Die prospektive, multizentrische Studie umfasste 502 Patienten an acht klinischen Zentren und zeigte einen starken Einfluss auf die Entscheidungen der Anbieter: 100% der EsoGuard-positiven Patienten wurden zur Bestätigungs-EDG überwiesen, während über 99% der EsoGuard-negativen Patienten nicht überwiesen wurden. Die Compliance-Rate war mehr als doppelt so hoch wie die übliche Überweisungsrate für Screening-EDGs in der veröffentlichten Literatur.
- 85% patient compliance rate with follow-up endoscopy, double the industry standard
- 100% provider referral rate for EsoGuard-positive patients
- Fourth peer-reviewed publication validating EsoGuard's clinical utility
- Strong provider decision impact with over 99% accuracy in referral decisions
- None.
Insights
The acceptance of the CLUE study for peer-reviewed publication represents a significant milestone for Lucid Diagnostics' EsoGuard® test. The 85% patient compliance rate for follow-up endoscopy is particularly impressive, more than doubling the typical compliance rates seen in traditional screening methods. This high compliance rate, combined with the 100% provider decision impact for positive cases and 99% for negative cases, demonstrates strong clinical utility.
The study's robust sample size of 502 patients across eight clinical centers provides compelling evidence for EsoGuard's effectiveness as a triage tool. This non-invasive approach could significantly reduce unnecessary endoscopies while ensuring high-risk patients receive appropriate follow-up care. The data strengthens Lucid's position in discussions with insurance payors, potentially accelerating reimbursement coverage decisions and market adoption.
This publication strengthens Lucid Diagnostics' market position in the esophageal cancer screening space. With a market cap of
The growing body of peer-reviewed evidence (now four publications) enhances the company's credibility with healthcare providers and payors. This could drive increased test adoption and help secure favorable reimbursement decisions, directly impacting the company's revenue potential and market penetration.
Study demonstrates outstanding clinical utility including an exceptionally high
"The final results from the CLUE study strongly support the clinical utility of EsoGuard as an effective triage tool for esophageal precancer testing of at-risk patients and we are deeply grateful to our investigators across eight clinical centers for their commitment to esophageal cancer prevention," said Victoria T. Lee, M.D., Lucid's Chief Medical Officer. "EsoGuard enables physicians to effectively triage patients at increased risk for esophageal precancer to confirmatory upper endoscopy. Once again, physicians consistently utilized our non-invasive EsoGuard test to appropriately refer patients to endoscopy, allowing the vast majority of patients to avoid this more expensive and invasive procedure. Patients, in turn, showed an exceptionally high level of compliance with their physician's referral to EGD. This patient compliance data and the study's full provider impact data supplements our strong evidence base of clinical validity, clinical utility and analytical validity data supporting our ongoing discussions with payors and other key stakeholders."
The full manuscript, entitled Real-world Clinical Utility of a Methylated DNA Biomarker Assay on Samples Collected with a Swallowable Capsule-balloon for Detection of Barrett's Esophagus (BE) is expected to be available in an upcoming online edition of Medicina, and follows the CLUE interim data report which was previously published in the Archives of Clinical and Biomedical Research in December of 2023.
The prospective, multicenter CLUE study enrolled patients who met gastroenterology society guideline criteria for esophageal precancer screening from eight clinical centers. A total of 502 patients contributed to the clinical utility endpoints. The study demonstrated strong provider decision impact—
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
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