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EsoGuard is a laboratory developed test which analyzes 31 methylated biomarkers and demonstrated over 90% specificity and 90% sensitivity in identifying Barrett’s Esophagus in a 408 patient NIH-sponsored clinical trial, published in Science Translational Medicine

 

The assay examines individual DNA molecules for the presence or absence of cytosine methylation at 31 different genomic locations.

"Methylated DNA biomarkers that have been shown to be highly accurate in detecting Barrett’s Esophagus"

Barrett’s Esophagus (BE) is an abnormal change in the cellular composition of the esophagus whereby the normal squamous lining changes under the influence of gastric reflux to a glandular intestinal metaplastic mucosa. This change increases the risk of affected individuals developing esophageal adenocarcinoma (EAC). BE is the only established precursor lesion of EAC. E The incidence of EAC is growing faster than any other cancer in the US — with a dismal five year survival rate of <20%. Most individuals with BE are unaware that they have BE and thus are unaware of their risk of developing EAC. 

EsoGuard uses next generation sequencing of bisulfate converted DNA to detect the presence of Vimentin and CyclinA1 methylation signatures [mVIM and mCCNA1] at 31 sites within those genes, reliably identifying individuals with Barrett’s Esophagus (BE). 

In a recent landmark Science Translational Medicine publication, Moinova et al compared esophageal brushings tested with EsoGuard, with esophageal tissue biopsies, evaluated with conventional histopathology in 322 patients with and without BE. EsoGuard was shown to have greater than 90% specificity and sensitivity at detecting non-dysplatic BE in these patients. 

Assay: DNA methylation is an important pathological process related to BE and EAC formation. DNA methylation is the result of a chemical reaction which occurs at specific sites known as CpG sites. These CpG sites commonly cluster in large groups — some of which are known as CpG islands. 

Custom proprietary software, incorporating advanced genetic informatics, uses an advanced algorithm to convert the DNA sequence at the target sites into a binary clinical result. 

EsoGuard assesses the presence of methylation in targeted regions of the Vimentin and CCNA1 genes after the specimens have undergone bisulfite conversion — a chemical step which allows characterization of DNA methylation at CpG sites. 

EsoGuard is used to detect non-dysplastic Barrett’s Esophagus including short segment and long segment, dysplastic BE including both low and high grade forms, adenocarcinoma of the esophagus including intramucosal, or adenocarcinoma of the gastroesophageal junction. 

REFERENCES

https://stm.sciencemag.org/content/10/424/eaao5848.editor-summary

 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4885788/

EsoGuard is a Laboratory Developed Test (LDT) and has not yet received clearance from the FDA or any other notified body.