Renowned Investigators Awarded $8 Million NIH Grant to Study Lucid Diagnostics' EsoGuard® in At-Risk Patients without Symptomatic GERD
Lucid Diagnostics (Nasdaq: LUCD) announced that a consortium of academic medical centers has received an $8 million NIH R01 grant for a five-year clinical study of its EsoCheck® and EsoGuard® technologies. The study will evaluate esophageal precancer detection in at-risk individuals without GERD symptoms.
The research, led by investigators from Case Western Reserve University and University Hospitals, will involve 800 patients across five research centers. The study aims to improve Barrett's Esophagus (BE) detection in non-GERD at-risk populations, who account for nearly half of esophageal cancer cases but are currently excluded from screening guidelines.
The study could potentially expand EsoGuard's target population for esophageal precancer testing. The technology was originally developed at CWRU and UH, with Lucid licensing the technologies exclusively in 2018.
Lucid Diagnostics (Nasdaq: LUCD) ha annunciato che un consorzio di centri medici accademici ha ricevuto un finanziamento NIH R01 di 8 milioni di dollari per uno studio clinico di cinque anni sulle sue tecnologie EsoCheck® ed EsoGuard®. Lo studio valuterà la rilevazione di precancerosi esofagei in individui a rischio senza sintomi di GERD.
La ricerca, guidata da investigatori della Case Western Reserve University e degli University Hospitals, coinvolgerà 800 pazienti in cinque centri di ricerca. L'obiettivo dello studio è migliorare la rilevazione dell'esofago di Barrett (BE) nelle popolazioni a rischio non affette da GERD, che rappresentano quasi la metà dei casi di cancro esofageo ma attualmente sono escluse dalle linee guida di screening.
Lo studio potrebbe potenzialmente ampliare la popolazione target di EsoGuard per i test di precancerosi esofagei. La tecnologia è stata originariamente sviluppata presso CWRU e UH, con Lucid che ha concesso in licenza le tecnologie in modo esclusivo nel 2018.
Lucid Diagnostics (Nasdaq: LUCD) anunció que un consorcio de centros médicos académicos ha recibido un subsidio NIH R01 de 8 millones de dólares para un estudio clínico de cinco años sobre sus tecnologías EsoCheck® y EsoGuard®. El estudio evaluará la detección de precáncer esofágico en individuos en riesgo sin síntomas de GERD.
La investigación, liderada por investigadores de la Case Western Reserve University y los University Hospitals, involucrará a 800 pacientes en cinco centros de investigación. El objetivo del estudio es mejorar la detección del esófago de Barrett (BE) en poblaciones en riesgo sin GERD, que representan casi la mitad de los casos de cáncer esofágico pero actualmente están excluidas de las guías de detección.
El estudio podría potencialmente ampliar la población objetivo de EsoGuard para las pruebas de precáncer esofágico. La tecnología fue desarrollada originalmente en CWRU y UH, con Lucid licenciando las tecnologías de manera exclusiva en 2018.
루시드 다이아그노스틱스 (Nasdaq: LUCD)는 학술 의료 센터 컨소시엄이 800만 달러 NIH R01 보조금을 받아 자사의 EsoCheck® 및 EsoGuard® 기술에 대한 5년 임상 연구를 진행한다고 발표했습니다. 이 연구는 GERD 증상이 없는 고위험 개인에서 식도 전암 검출을 평가할 것입니다.
Case Western Reserve University와 University Hospitals의 연구자들이 이끄는 이번 연구는 800명의 환자를 포함하여 5개의 연구 센터에서 진행됩니다. 이 연구의 목표는 GERD가 없는 고위험 인구에서 Barrett 식도(BE) 검출을 개선하는 것이며, 이들은 식도암 사례의 거의 절반을 차지하지만 현재 스크리닝 지침에서 제외되어 있습니다.
이 연구는 EsoGuard의 식도 전암 검사 대상 인구를 확장할 수 있는 잠재력을 가지고 있습니다. 이 기술은 원래 CWRU와 UH에서 개발되었으며, Lucid는 2018년에 기술을 독점적으로 라이센스했습니다.
Lucid Diagnostics (Nasdaq: LUCD) a annoncé qu'un consortium de centres médicaux universitaires a reçu une subvention NIH R01 de 8 millions de dollars pour une étude clinique de cinq ans sur ses technologies EsoCheck® et EsoGuard®. L'étude évaluera la détection de précancer oesophagien chez des personnes à risque sans symptômes de GERD.
La recherche, dirigée par des chercheurs de la Case Western Reserve University et des University Hospitals, impliquera 800 patients dans cinq centres de recherche. L'objectif de l'étude est d'améliorer la détection de l'œsophage de Barrett (BE) dans les populations à risque non atteintes de GERD, qui représentent près de la moitié des cas de cancer de l'œsophage mais qui sont actuellement exclues des directives de dépistage.
L'étude pourrait potentiellement élargir la population cible d'EsoGuard pour les tests de précancer oesophagien. La technologie a été développée à l'origine à la CWRU et à l'UH, Lucid ayant obtenu une licence exclusive sur les technologies en 2018.
Lucid Diagnostics (Nasdaq: LUCD) gab bekannt, dass ein Konsortium akademischer medizinischer Zentren einen NIH R01 Zuschuss in Höhe von 8 Millionen Dollar für eine fünfjährige klinische Studie zu seinen Technologien EsoCheck® und EsoGuard® erhalten hat. Die Studie wird die Erkennung von esophagealen Präkanzerosen bei gefährdeten Personen ohne GERD-Symptome bewerten.
Die Forschung, die von Forschern der Case Western Reserve University und der University Hospitals geleitet wird, wird 800 Patienten in fünf Forschungszentren umfassen. Ziel der Studie ist es, die Erkennung von Barrett-Ösophagus (BE) in nicht-GERD gefährdeten Populationen zu verbessern, die fast die Hälfte der Fälle von Speiseröhrenkrebs ausmachen, aber derzeit von den Screening-Richtlinien ausgeschlossen sind.
Die Studie könnte potenziell die Zielpopulation von EsoGuard für Tests auf esophageale Präkanzerosen erweitern. Die Technologie wurde ursprünglich an der CWRU und UH entwickelt, wobei Lucid die Technologien 2018 exklusiv lizenziert hat.
- Secured $8M NIH grant funding for clinical study
- Potential expansion of target market to non-GERD patients
- Partnership with prestigious research institutions
- Study results won't be available for 5 years
- Current screening guidelines exclude non-GERD patients, limiting immediate market
Insights
The $8 million NIH grant awarded to study Lucid Diagnostics' EsoGuard technology represents a potentially significant market expansion opportunity for this small-cap company. By targeting at-risk patients without GERD symptoms—who comprise nearly 50% of esophageal cancer cases but remain unscreened under current guidelines—Lucid could substantially increase its addressable market.
From a financial perspective, this development carries several implications:
- With Lucid's modest $84 million market cap, successful study outcomes could disproportionately impact valuation by validating their technology in a broader population
- The NIH funding structure means minimal capital outlay from Lucid beyond providing their technology, preserving their cash position
- The five-year study timeline creates a long-term catalyst rather than immediate revenue impact, requiring investor patience
This study addresses a critical clinical need with substantial market potential. The 20% five-year survival rate for esophageal cancer underscores the value of early detection, aligning with healthcare's preventative focus. NIH backing provides scientific credibility that could accelerate commercial adoption and potentially influence insurance coverage decisions.
For investors, this represents a de-risked R&D opportunity where external funding supports market expansion research. However, the extended timeline means this should be viewed as a long-term value driver rather than a near-term catalyst, with commercial benefits unlikely before 2030.
Lucid to support study of this expanded indication for esophageal precancer testing in partnership with NIH investigators
The study, "A Clinical Trial of Cancer Prevention by Biomarker Based Detections of Barrett's Esophagus and Its Progression," aims to evaluate the effectiveness of EsoCheck and EsoGuard in detecting esophageal precancer (Barrett's Esophagus or BE) to prevent esophageal cancer (EAC) within a non-GERD at-risk population. To accomplish this aim, 800 patients without GERD symptoms who meet the American Gastroenterological Association's (AGA) risk criteria for screening will be recruited across five participating research centers: University Hospitals, University of
"Patients without GERD symptoms account for nearly half of prevalent esophageal cancer cases," said Amitabh Chak, M.D., Professor of Medicine and Oncology at CWRU, gastroenterologist at UH, and the Brenda and Marshall B. Brown Master Clinician in Innovation and Discovery at UH Seidman Cancer Center. "However, these individuals would be excluded from screening based on the American College of Gastroenterology (ACG) guidelines where chronic GERD is a mandatory prerequisite. We aim to utilize EsoCheck and EsoGuard to improve BE detection in this at-risk population that would otherwise go unscreened, and to do so in a manner that does not over-tax limited endoscopy resources. Given the dismal
"We are excited to support this landmark study, continuing our longstanding collaboration with Drs. Amitabh Chak, Sanford Markowitz, and Joseph Willis, principal investigators on the NIH grant, and are gratified that the NIH has committed substantial resources focused on our technology," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "This study has the potential to significantly expand the target population for EsoGuard esophageal precancer testing."
The technology behind EsoGuard and EsoCheck was developed at CWRU and UH by faculty members Sanford Markowitz, M.D., Ph.D., Amitabh Chak, M.D., Joseph Willis, M.D., and Helen Moinova, Ph.D. They have collaborated closely with the Lucid team since Lucid licensed the technologies on an exclusive basis from CWRU in 2018.
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.
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SOURCE Lucid Diagnostics
FAQ
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