EsoGuard BE-1 Trial Validates Effective Screening for Esophageal Precancer
The ESOGUARD BE-1 trial demonstrated that the EsoGuard test, combined with EsoCheck, effectively detects esophageal precancer and supports its use as a screening tool to prevent esophageal cancer.
3D rendered medically accurate illustration of esophagus cancer: © Sebastian Kaulitzki - stock.adobe.com
EsoGuard demonstrated promise in the detection of esophageal precancer (Barrett's Esophagus; BE) and esophageal adenocarcinoma (EAC), showing a sensitivity of 87.5% and negative predictive value (NPV) of 98.6%, according to positive data from the ESOGUARD BE-1 trial (NCT04293458).1
ESOGUARD BE-1 sought to evaluate the performance of the EsoGuard Esophageal DNA test on samples collected with the EsoCheck Esophageal Cell Collection Device to help detect esophageal precancer and EAC in a screening population. Of the 93 patients included in the primary end point analysis, 8 had BE without dysplasia, and the disease prevalence was 8.6%. There were no patients with EAC.
In addition to the EsoGuard sensitivity for BE being 87.5%, the specificity was 81.2%. The positive predictive value (PPV) was 30.4%, and the NPV was 98.6%.
"This second multicenter clinical validation study in an intendeduse screening population demonstrates nearly identical EsoGuard performance compared to 2 previously reported National Cancer Institute (NCI)-funded case-control studies—a multi-center pivotal study published in Science Translational Medicine introducing the technology and a multicenter study from the BETRNet consortium recently published in the American Journal of Gastroenterology,” said Victoria T. Lee, MD, Lucid's chief medical officer, in a press release.
This trial marks the second clinical validation study in a screening population. The first study previously reported positive data from a separate prospective study, the Cleveland VA screening study. This study was also recently accepted for peer-reviewed publication.
“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%. Collectively, these 4 clinical validity studies demonstrate an unprecedented performance of a molecular diagnostic test in detecting a precancer. They strongly support EsoGuard's use as a widespread screening tool to prevent esophageal cancer through the early detection of esophageal precancer," added Lee in the press release.
In the prospective, international, multicenter, single-arm ESOGUARD BE-1 trial, EsoGuard’s performance was assessed in 93 subjects who met the criteria for esophageal precancer screening based on American College of Gastroenterology (ACG) guidelines. These patients were required to undergo EsoCheck cell collection, have binary EsoGuard results, and obtain a definitive final diagnosis established by upper gastrointestinal endoscopy and biopsies.
Enrollment was open to male patients aged 50 years old and older. Patients were required to have either ≥5 years of gastroesophageal reflux disease (GERD) symptoms, GERD treated with proton pump inhibitor therapy, or any combination of treated and untreated periods if the cumulative total is at least 5 years.2 Patients were not allowed to eat solid foods for at least 2 hours prior to EsoCheck procedure, and patients must have had 1 or more of the following risk factors:
- Caucasian race
- Current or past history of cigarette smoking
- BMI of at least 30 kg/m2
- First-degree relative with BE or EAC
The primary end point was to evaluate the sensitivity and specificity of EsoGuard, and the secondary end point was NPV and PPV calculated for the observed prevalence and over a range of prevalence from 1% to 15%.
