Pavmed (NSDQ:PAVM) subsidiary Lucid Diagnostics announced today that investigators enrolled the first patient in a stud of its EsoGuard.
Investigators at the Louis Stokes Cleveland Department of Veterans Affairs Medical Center (Cleveland VA) enrolled the patient in a U.S. Defense Dept. (DoD)-funded study of the EsoGuard esophageal DNA test for at-risk patients with gastroesophageal reflux disease (GERD).
Lucid Diagnostics is providing EsoCheck esophageal cell collection devices for the study and will perform EsoGuard testing on the samples collected. Cleveland VA gastroenterologist Dr. Katarina B. Greer serves as the study’s principal investigator.
“We are proud to be partnering with Dr. Greer and the Cleveland VA on this important investigator-initiated clinical study,” Lucid Diagnostics Chairperson and CEO Dr. Lishan Aklog said in a news release. “The study will add important clinical evidence on the impact of EsoGuard in enhancing early detection of esophageal precancer to prevent esophageal cancer deaths by reserving endoscopy for those with a positive EsoGuard test.”
EsoGuard performed on samples collected with EsoCheck has demonstrated 90% sensitivity and specificity in detecting esophageal precancer and cancer, Lucid Diagnostics said. This offers the potential to eliminate the majority of invasive upper gastrointestinal endoscopies (EGDs) to deliver benefits to patients, providers and the healthcare system, the company added.
The study will enroll up to 100 Cleveland VA patients who fulfill the American College of Gastroenterology criteria for esophageal precancer screening. It will report whether using EsoGuard to triage patients to EGD will increase the overall Barrett’s Esophagus (BE) screening rate and decrease the percentage of negative screening EGDs. It will also assess cost implications within the VA system between the two strategies.
“Despite strong clinical practice guideline recommendations, endoscopy has had limited success as a widespread screening tool for BE, a precursor for esophageal adenocarcinoma, a highly lethal form of esophageal cancer,” Dr. Greer said. “We hope to demonstrate that a strategy which incorporates initial office-based non-endoscopic testing of at-risk patients with EsoGuard improve the yield of endoscopy and overall cost-effectiveness.”