Lucid Diagnostics, New York City, has contracted Pivotal, Madrid, Spain, to provide clinical research services for upcoming studies of Lucid’s gastrointestinal in vitro diagnostics EsoGuard and EsoCheck in Europe and the United States. The trials will research Barrett’s esophagus with and without dysplasia, precursor conditions to highly lethal esophageal cancer (EAC), and EAC itself in patients with gastroesophageal reflux disease (GERD).
Barrett’s esophagus is a change of the normal squamous epithelium of the distal esophagus to a columnar-lined intestinal metaplasia. The condition has been detected in approximately 15% of patients with GERD and in approximately 1% to 2% of population subjects. Recent population studies suggest that prevalence of GERD is increasing.
Barrett’s esophagus is a known risk factor for developing dysplasia and EAC, which is rapidly increasing in nations in the Western Hemisphere. EAC is a highly lethal condition; the main goal of a screening and surveillance program for Barrett’s esophagus is to identify individuals at risk for progression to EAC and to treat them early.
Currently, endoscopy is the gold standard for surveillance in Barrett’s esophagus with biopsy sampling. But new less-invasive diagnostic tests with increased sensitivity and specificity for Barrett’s esophagus are needed.
Lucid’s FDA 510(k)-cleared EsoCheck cell collection device with proprietary Collect+Protect technology is a noninvasive device designed to sample cells from a targeted region of the esophagus in a 5-minute office-based procedure, without the need for endoscopy.
The EsoGuard esophageal DNA test performs next-generation sequencing of bisulfite-converted DNA to detect methylation at 31 sites on two genes (CCNA1 and VIM). In a 408-patient human study, EsoGuard was shown to be highly accurate at detecting Barrett’s esophagus with and without dysplasia, as well as EAC, with greater than 90% sensitivity and specificity.
“These studies are critical to our efforts to demonstrate that EsoGuard and EsoCheck have the potential to prevent deaths from esophageal cancer through early detection, monitoring, and treatment,” says Lishan Aklog, MD, executive chairman of Lucid Diagnostics. “We look forward to working with Pivotal to make this happen.”
For further information, visit Pivotal.