Lucid Diagnostics has unveiled positive data from its ESOGUARD BE-1 trial of the EsoGuard Esophageal DNA test for the detection of oesophageal precancer (Barrett’s oesophagus or BE) and oesophageal adenocarcinoma (EAC).
The prospective, international, multicentre, single-arm ESOGUARD BE-1 trial was conducted to clinically validate the performance of the EsoGuard test to detect BE and EAC in a screening population.
The EsoGuard Esophageal DNA test was used on samples collected with the EsoCheck Esophageal Cell Collection Device from 93 individuals.
According to Lucid Diagnostics, which is a subsidiary of PAVmed, the study demonstrated a sensitivity of 87.5% and a negative predictive value (NPV) of 98.6% for the test.
EsoGuard also showed a specificity of 81.2%, a positive predictive value of 30.4%, and a negative predictive value of 98.6%.
The subjects met the criteria for the screening of oesophageal precancer based on American College of Gastroenterology (ACG) guidelines.
The patients underwent EsoCheck cell collection, received binary EsoGuard results, and had their definitive final diagnosis established by upper gastrointestinal endoscopy and biopsies.
Eight of the total subjects included in the primary endpoint analysis had Barrett’s oesophagus without dysplasia, indicating a disease prevalence of 8.6%, with no EAC cases.
The study represents the second clinical validation in a screening population, following previously announced positive findings from the Cleveland VA screening trial.
The ESOGUARD BE-1 study was conducted at Baylor College of Medicine, University of California-Irvine, Vanderbilt University, University of Utah, and other US and European centres.
Lucid Diagnostics chief medical officer Victoria Lee said: “This second multi-centre clinical validation study in an intended use screening population demonstrates nearly identical EsoGuard performance compared to two previously reported National Cancer Institute (NCI)-funded case-control studies—a multi-centre pivotal study published in Science Translational Medicine introducing the technology and a multi-centre study from the BETRNet consortium recently published in the American Journal of Gastroenterology.
“Additionally, the previously announced and now peer-reviewed results of the Cleveland VA screening study demonstrated an identical NPV, and a similar sensitivity of 92.9%.”
