Lucid Diagnostics Inc.

Lucid Diagnostics Inc. is a commercial-stage medical diagnostics technology company focused on cancer prevention. The company targets millions of patients with gastroesophageal reflux disease (GERD), or chronic heartburn, who are at risk of developing esophageal precancer and esophageal adenocarcinoma (EAC). Lucid's primary product is the EsoGuard Esophageal DNA Test, which uses samples collected with the EsoCheck Esophageal Cell Collection Device. Lucid believes this combination is the first and only commercially available diagnostic test designed to prevent EAC deaths through early detection of esophageal precancer in at-risk GERD patients. The EsoGuard test is a bisulfite-converted targeted next-generation sequencing (NGS) DNA assay. It quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1), using surface esophageal cells. Analytical validation tests showed EsoGuard has approximately 97% analytical sensitivity, 95% analytical specificity, 98% analytical accuracy, and 100% inter-assay and intra-assay precision. In screening studies, EsoGuard demonstrated a positive predictive value (PPV) of 30-33% and a negative predictive value (NPV) of 99% for detecting Barrett's esophagus (BE) and EAC. The EsoCheck device, which is FDA 510(k)-cleared and CE Mark certified, is a noninvasive swallowable balloon capsule catheter. It is designed for in-office targeted sampling of surface esophageal cells in a procedure lasting less than two minutes. The device consists of a vitamin-sized semi-rigid plastic capsule tethered to a thin silicone catheter, from which a soft inflatable silicone balloon with textured ridges emerges to swab cells.