EsoGuard is a laboratory developed test that have been proven to show over 90% specificity and 90% sensitivity in identifying biomarkers for Barrett’s Esophagus (published article in STM can be found here). The assay examines individual DNA molecules for the presence or absence of cytosine methylation at 31 different genomic locations.
EsoGuard identified cytosine methylation of the CCNA1 locus as a methylation marker of BE. Additionally, EsoGuard has shown that molecular cytology assays of distal esophageal brushings, by bisulfite sequencing detection of the two-marker panel of mVIM and mCCNA1 DNAs, detect BE and EAC with sensitivity and specificity both greater than 90%
EsoGuard will be used to detect, diagnose and manage patients with non-dysplastic Barrett’s esophagus including short segment and long segment, dysplastic Barrett’s esophagus including both low and high grade forms, adenocarcinoma of the esophagus including intramucosal, or adenocarcinoma of the gastroesophageal junction.