Lucid Diagnostics

Lucid Diagnostics Inc. is a subsidiary of PAVmed Inc (Nasdaq: PAVM) that has breakthrough devices, EsoCheck and EsoGuard, for esophageal cell collection and diagnosis of Barrett's Esophagus. EsoCheck is a cell collection/sampling device that is designed to be a non-endoscopic balloon capsule catheter for use in the collection and retrieval of surface cells of the esophagus. The sampled cells can then be combined with any commercially available diagnostic tests to diagnose an array of disease states. EsoCheck allows patients to undergo a non-invasive five-minute office-based procedure to collect cells from the esophagus for analysis. The patient swallows a vitamin pill-sized capsule containing a small inflatable balloon attached to a thin catheter. As the catheter is withdrawn, it swabs the target area for a sample of cells and protects that sample from contamination as the device is removed. EsoGuard is a laboratory developed test that have been proven to show over 90% specificity and 90% sensitivity in identifying biomarkers for Barrett’s Esophagus (published article in STM can be found here). The assay examines individual DNA molecules for the presence or absence of cytosine methylation at 31 different genomic locations. EsoGuard identified cytosine methylation of the CCNA1 locus as a methylation marker of BE. Additionally, EsoGuard has shown that molecular cytology assays of distal esophageal brushings, by bisulfite sequencing detection of the two-marker panel of mVIM and mCCNA1 DNAs, detect BE and EAC with sensitivity and specificity both greater than 90% EsoGuard will be used to detect, diagnose and manage patients with non-dysplastic Barrett’s esophagus including short segment and long segment, dysplastic Barrett’s esophagus including both low and high grade forms, adenocarcinoma of the esophagus including intramucosal, or adenocarcinoma of the gastroesophageal junction.