Lucid Diagnostics Inc. (LUCD), a subsidiary of PAVmed Inc. (PAVM), Thursday reported positive data from a National Cancer Institute (NCI)-sponsored study of its EsoGuard Esophageal DNA Test in patients without symptoms of chronic gastroesophageal reflux disease (GERD).
The study was conducted at Case Western Reserve University (CWRU) and University Hospitals (UH) and enrolled patients without GERD symptoms who otherwise met American Gastroenterological Association (AGA) recommendations for esophageal precancer (Barrett's Esophagus or BE) screening.
In the study, EsoGuard showed excellent negative predictive value (NPV) of 100% for detecting esophageal precancer, consistent with its unprecedented precancer detection reported across multiple peer-reviewed clinical validity studies in patients with symptomatic GERD. The study also showed a BE prevalence of 8.4%, a rate comparable to the established prevalence in patients with symptomatic GERD.
A National Institutes of Health (NIH)-sponsored study of EsoGuard is underway.
"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 $60 billion market opportunity for EsoGuard esophageal precancer testing could increase by as much as 70 percent," said Lishan Aklog, Lucid's Chairman and Chief Executive Officer.
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