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Lucid Diagnostics Provides Updates on Newly Published Esophageal Precancer Clinical Guideline and Proposed Medicare Local Coverage Determination

Updated American College of Gastroenterology clinical guideline supports esophageal precancer screening with EsoGuard on samples collected with EsoCheck
Proposed Medicare Local Coverage Determination published by Palmetto GBA’s MolDX Program triggers comment period in advance of public meeting

Lucid Diagnostics Inc. (“Lucid”, the “Company”), a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (“PAVmed”), announced that a newly updated American College of Gastroenterology (“ACG”) clinical guideline supports esophageal precancer (“Barrett’s Esophagus”, “BE”) screening to prevent highly lethal esophageal cancer (“EAC”) utilizing its EsoGuard DNA Test on samples collected with its EsoCheck Cell Collection Device. It also provided an update on, and planned response to, a proposed Local Coverage Determination on molecular testing for esophageal precancer and cancer published by Medicare Administrative Contractor (“MAC”) Palmetto GBA’s MolDX Program, triggering a comment period in advance of a public meeting.

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“Diagnosis and Management of Barrett’s Esophagus: An Updated ACG Guideline”

Updated ACG Guideline
An ACG clinical guideline entitled “Diagnosis and Management of Barrett’s Esophagus: An Updated ACG Guideline,” the first such update since 2016, was published online last week in the American Journal of Gastroenterology. Lead author Nicholas J. Shaheen, M.D., Bozymski-William Heizer Distinguished Professor of Medicine at the University of North Carolina, chairs Lucid’s Medical Advisory Board (MAB) and serves as principal investigator of its ESOGUARD BE-1 and BE-2 clinical trials. Co-author Gary W. Falk, M.D., Professor of Medicine at the University of Pennsylvania School of Medicine, also serves on the Lucid MAB and as principal investigator of its eosinophilic esophagitis clinical trials.

The clinical guideline first reiterates the ACG’s long-standing recommendation for esophageal precancer screening in at-risk patients with gastroesophageal reflux disease (“GERD”), commonly known as chronic heartburn, acid reflux, or simply reflux.

Recommendation 5: We suggest a single screening endoscopy in patients with chronic GERD symptoms and 3 or more additional risk factors for BE, including male sex, age >50 yr, White race, tobacco smoking, obesity, and family history of BE or EAC in a first-degree relative.

For the first time, however, the clinical guideline also endorses nonendoscopic biomarker screening as an acceptable alternative to costly and invasive endoscopy.

Recommendation 6: We suggest that a swallowable, nonendoscopic capsule device combined with a biomarker is an acceptable alternative to endoscopy for screening for BE.

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The clinical guideline specifically mentions EsoCheck, along with Lucid’s EsophaCap device, as such swallowable, nonendoscopic esophageal cell collection devices, as well as methylated DNA biomarkers such as EsoGuard. The summary of evidence for this recommendation cites the seminal NIH-funded, multicenter, case-control study published in 2018 in Science Translational Medicine, which demonstrated that EsoGuard is highly accurate at detecting esophageal precancer and cancer, including on samples collected with EsoCheck.

“Publication of this updated ACG clinical guideline is a critical milestone which has the potential to save many lives by, for the first time, driving widespread screening to prevent esophageal cancer deaths through the early detection of esophageal precancer,” said Lishan Aklog M.D., Lucid’s Chairman and Chief Executive Officer. “Although, for over a decade, gastroenterology clinical guidelines have recommended esophageal precancer screening in GERD patients with long-established risk factors, very few patients undergo endoscopic screening—making the many thousands of annual esophageal deaths in the U.S. a profound and preventable tragedy. EsoGuard and EsoCheck represent the only ‘swallowable, nonendoscopic capsule device combined with a biomarker’ currently available in the U.S. to serve as such a widespread screening tool to prevent these tragic deaths.”

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