Lucid Diagnostics Inc.
Unless the context otherwise requires, we , us , and our , the Company , Lucid and Lucid Diagnostics refer to Lucid Diagnostics Inc. and its subsidiaries LucidDx Labs Inc. ( LucidDx Labs ) and CapNost…
Unless the context otherwise requires, we , us , and our , the Company , Lucid and Lucid Diagnostics refer to Lucid Diagnostics Inc. and its subsidiaries LucidDx Labs Inc. ( LucidDx Labs ) and CapNostics, LLC ( CapNostics ). Background and Overview Lucid Diagnostics is a commercial-stage cancer prevention medical diagnostics technology company. 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, specifically highly lethal esophageal adenocarcinoma ( EAC ). We believe that our flagship product, the EsoGuard Esophageal DNA Test, performed on samples collected with the EsoCheck Esophageal Cell Collection Device, constitutes the first and only commercially available diagnostic test capable of serving as a widespread testing tool with the goal of preventing EAC deaths, through early detection of esophageal precancer in at-risk GERD patients. EsoGuard is a bisulfite-converted targeted next-generation sequencing ("NGS") DNA assay performed on surface esophageal cells collected with the FDA 510(k)-cleared EsoCheck device. It quantifies methylation at 31 sites on two genes, Vimentin ("VIM") and Cyclin A1 ("CCNA1"). Analytical validation tests of EsoGuard demonstrated approximately 97% analytical sensitivity, 95% analytical specificity, 98% analytical accuracy, and 100% inter-assay and intra-assay precision. Performance characteristics of the EsoGuard test have been evaluated in two case-control studies and two prospective, single-arm cohort studies.
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