NEW YORK – Lucid Diagnostics announced Thursday that a consortium of academic medical centers has received an $8 million grant from the US National Institutes of Health to evaluate Lucid's esophageal cell collection device and esophageal precancer test.
The team, which includes principal investigators from Case Western Reserve University and University Hospitals, will conduct a five-year clinical study that is intended to evaluate Lucid's EsoCheck Esophageal Cell Collection Device and EsoGuard Esophageal DNA test in at-risk patients without symptoms of chronic gastroesophageal reflux disease.
The study aims to determine the effectiveness of EsoCheck and EsoGuard in detecting esophageal precancer, or Barrett's esophagus, to prevent esophageal cancer and will recruit 800 patients across five participating research centers, Lucid said in a statement. The research centers are University Hospitals, the University of Colorado, Johns Hopkins University, the University of North Carolina, and Cleveland Clinic.
The study "has the potential to significantly expand the target population for EsoGuard esophageal precancer testing," Lucid Diagnostics Chairman and CEO Lishan Aklog said in a statement.
"Patients without GERD symptoms account for nearly half of prevalent esophageal cancer cases," Amitabh Chak, a professor of medicine and oncology at Case Western Reserve and one of the principal investigators on the study, added. "However, these individuals would be excluded from screening based on the American College of Gastroenterology guidelines where chronic GERD is a mandatory prerequisite."
"We aim to utilize EsoCheck and EsoGuard to improve BE detection in this at-risk population that would otherwise go unscreened and to do so in a manner that does not overtax limited endoscopy resources," Chak said.
Lucid, a subsidiary of Pavmed, exclusively licensed the underlying EsoGuard and EsoCheck technology from Case Western Reserve in 2018. EsoCheck consists of a capsule with a balloon on the end of a silicon catheter string that inflates and captures cells from a targeted area of the lower esophagus once a person swallows. EsoGuard uses DNA bisulfite conversion, PCR amplification, and next-generation sequencing to determine the methylation status of 31 sites in the vimentin and cyclin A1 genes, which indicates Barrett's esophagus.