NCI-Sponsored Study Shows Positive Data for Lucid Diagnostics' EsoGuard® Esophageal DNA Test in Patients Without Symptomatic GERD
Lucid Diagnostics (LUCD) has announced positive results from a National Cancer Institute-sponsored study of its EsoGuard® Esophageal DNA Test in detecting esophageal precancer (Barrett's Esophagus) among at-risk patients without GERD symptoms. The study demonstrated an excellent 100% negative predictive value for precancer detection and showed a Barrett's Esophagus prevalence of 8.4% in asymptomatic patients.
The findings support expanding EsoGuard testing to a broader population, aligning with American Gastroenterological Association guidelines. These positive results have led to a larger ongoing five-year multicenter clinical study supported by an $8 million NIH R01 grant. According to the company, if these results are replicated in the ongoing study, the approximately $60 billion market opportunity for EsoGuard could increase by up to 70 percent.
Lucid Diagnostics (LUCD) ha annunciato risultati positivi da uno studio sponsorizzato dal National Cancer Institute sul suo EsoGuard® Esophageal DNA Test per la rilevazione del precancro esofageo (esofago di Barrett) in pazienti a rischio senza sintomi di GERD. Lo studio ha dimostrato un eccellente valore predittivo negativo del 100% per la rilevazione del precancro e ha evidenziato una prevalenza dell'esofago di Barrett dell'8,4% nei pazienti asintomatici.
I risultati supportano l'ampliamento dell'uso del test EsoGuard a una popolazione più ampia, in linea con le linee guida dell'American Gastroenterological Association. Questi esiti positivi hanno portato a uno studio clinico multicentrico più ampio e in corso della durata di cinque anni, finanziato da una borsa di studio NIH R01 da 8 milioni di dollari. Secondo l'azienda, se tali risultati verranno confermati nello studio in corso, l'opportunità di mercato di circa 60 miliardi di dollari per EsoGuard potrebbe aumentare fino al 70%.
Lucid Diagnostics (LUCD) ha anunciado resultados positivos de un estudio patrocinado por el National Cancer Institute sobre su EsoGuard® Esophageal DNA Test para detectar precáncer esofágico (esófago de Barrett) en pacientes en riesgo sin síntomas de ERGE. El estudio demostró un excelente valor predictivo negativo del 100% para la detección de precáncer y mostró una prevalencia del esófago de Barrett del 8,4% en pacientes asintomáticos.
Los hallazgos respaldan la ampliación del uso de la prueba EsoGuard a una población más amplia, en línea con las directrices de la American Gastroenterological Association. Estos resultados positivos han dado lugar a un estudio clínico multicéntrico más amplio y en curso de cinco años, apoyado por una subvención NIH R01 de 8 millones de dólares. Según la empresa, si estos resultados se replican en el estudio en curso, la oportunidad de mercado de aproximadamente 60 mil millones de dólares para EsoGuard podría aumentar hasta en un 70%.
Lucid Diagnostics (LUCD)는 National Cancer Institute가 후원한 연구에서 EsoGuard® 식도 DNA 검사가 GERD 증상이 없는 위험군 환자에서 식도 전암(바렛 식도)을 감지하는 데 긍정적인 결과를 발표했습니다. 이 연구는 전암 감지에 대해 100% 음성 예측값을 보여주었으며, 무증상 환자에서 바렛 식도의 유병률이 8.4%임을 확인했습니다.
이 결과는 미국 위장병학회(American Gastroenterological Association) 가이드라인에 따라 EsoGuard 검사를 더 넓은 인구로 확대하는 것을 지지합니다. 이러한 긍정적인 결과로 인해 800만 달러 NIH R01 보조금 지원을 받는 5년간 다기관 임상 연구가 현재 진행 중입니다. 회사에 따르면, 진행 중인 연구에서 이 결과가 재현된다면 EsoGuard의 약 600억 달러 시장 기회가 최대 70%까지 증가할 수 있다고 합니다.
Lucid Diagnostics (LUCD) a annoncé des résultats positifs issus d'une étude financée par le National Cancer Institute sur son test ADN EsoGuard® pour l'œsophage, destiné à détecter le précancer de l'œsophage (œsophage de Barrett) chez des patients à risque sans symptômes de RGO. L'étude a démontré une excellente valeur prédictive négative de 100% pour la détection du précancer et a révélé une prévalence de l'œsophage de Barrett de 8,4 % chez les patients asymptomatiques.
Ces résultats soutiennent l'élargissement du test EsoGuard à une population plus large, conformément aux directives de l'American Gastroenterological Association. Ces résultats positifs ont conduit à une étude clinique multicentrique plus vaste, en cours sur cinq ans, financée par une subvention NIH R01 de 8 millions de dollars. Selon l'entreprise, si ces résultats sont confirmés dans l'étude en cours, le marché potentiel d'environ 60 milliards de dollars pour EsoGuard pourrait augmenter jusqu'à 70 %.
Lucid Diagnostics (LUCD) hat positive Ergebnisse einer vom National Cancer Institute unterstützten Studie zu seinem EsoGuard® Esophageal DNA Test zur Erkennung von Speiseröhren-Vorstadien (Barrett-Ösophagus) bei Risikopatienten ohne GERD-Symptome bekannt gegeben. Die Studie zeigte einen ausgezeichneten negativen prädiktiven Wert von 100% für die Erkennung von Vorstufen und eine Prävalenz von Barrett-Ösophagus von 8,4 % bei asymptomatischen Patienten.
Die Ergebnisse unterstützen die Ausweitung der EsoGuard-Tests auf eine breitere Patientengruppe, in Übereinstimmung mit den Richtlinien der American Gastroenterological Association. Diese positiven Resultate führten zu einer größeren, laufenden, fünfjährigen multizentrischen klinischen Studie, die durch einen 8 Millionen US-Dollar NIH R01 Zuschuss gefördert wird. Laut dem Unternehmen könnte sich, falls diese Ergebnisse in der laufenden Studie bestätigt werden, die etwa 60 Milliarden US-Dollar umfassende Marktchance für EsoGuard um bis zu 70 Prozent erhöhen.
- 100% negative predictive value in detecting esophageal precancer
- Potential 70% increase in $60 billion market opportunity
- Secured $8 million NIH R01 grant for expanded clinical study
- 8.4% Barrett's Esophagus detection rate comparable to GERD patients
- Study results still need replication in larger multicenter trial
- Current findings to preliminary study pending peer review
Insights
EsoGuard's proven efficacy in detecting esophageal precancer among asymptomatic patients significantly expands its clinical utility and market potential.
The NCI-sponsored study of Lucid Diagnostics' EsoGuard® test reveals groundbreaking clinical potential by demonstrating efficacy in patients without GERD symptoms. The reported
What makes this particularly significant is the
The existing American Gastroenterological Association guidelines already support screening certain asymptomatic patients with risk factors, but suitable non-invasive testing options have been EsoGuard could fill this critical gap in the clinical pathway.
The follow-up
From a clinical implementation perspective, this positions EsoGuard as a potential first-line screening option for a substantially broader population, optimizing resource utilization by identifying patients who truly need endoscopic evaluation while sparing low-risk individuals from unnecessary invasive procedures.
Lucid's EsoGuard test demonstrates substantial market expansion potential through scientifically validated application in asymptomatic populations, significantly increasing addressable market.
This clinical validation represents a potential inflection point for Lucid Diagnostics' commercial trajectory and shareholder value proposition. The study establishes scientific credibility for expanding EsoGuard testing beyond symptomatic GERD patients to include asymptomatic at-risk individuals, effectively creating an entirely new addressable market segment.
The CEO's projection of a
The NCI sponsorship and subsequent
The
For investors evaluating Lucid's long-term potential, this study substantially derisks the core technology while simultaneously expanding its addressable market. The ongoing five-year multicenter study provides a clear catalyst pathway and developmental roadmap that could drive significant value creation if positive results are replicated.
Study supports expanded indication and market opportunity for EsoGuard esophageal precancer testing
The study was conducted by investigators at Case Western Reserve University (CWRU) and University Hospitals (UH) and enrolled patients without GERD symptoms who otherwise met AGA recommendations for BE screening. EsoGuard demonstrated excellent negative predictive value (NPV) of
"This study represents yet another piece of evidence that EsoGuard is highly effective at detecting esophageal precancer to prevent cancer," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "The meaningful BE prevalence reported in this study establishes the asymptomatic population as a viable target for BE screening. If these promising results are replicated in the ongoing multicenter NIH-sponsored study, the 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 about Lucid, 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 Diagnostics' 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 Diagnostics' common stock; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required to advance Lucid Diagnostics' products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from Lucid Diagnostics' clinical and preclinical studies; whether and when Lucid Diagnostics' products are cleared by regulatory authorities; market acceptance of Lucid Diagnostics' products once cleared and commercialized; Lucid Diagnostics' ability to raise additional funding as needed; and other competitive developments. These factors are difficult or impossible to predict accurately and many of them are beyond Lucid Diagnostics' 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 Diagnostics' future operations, see Part I, Item 1A, "Risk Factors," in Lucid Diagnostics' 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 Diagnostics 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.
View original content to download multimedia:https://www.prnewswire.com/news-releases/nci-sponsored-study-shows-positive-data-for-lucid-diagnostics-esoguard-esophageal-dna-test-in-patients-without-symptomatic-gerd-302436958.html
SOURCE Lucid Diagnostics
FAQ
What were the key findings of the NCI-sponsored study for Lucid Diagnostics' EsoGuard test (LUCD)?
How could the EsoGuard study results impact LUCD's market opportunity?
What is the significance of the $8 million NIH grant for Lucid Diagnostics (LUCD)?
How does the Barrett's Esophagus prevalence in asymptomatic patients compare to GERD patients for LUCD's EsoGuard?
