Biomarker-based non-endoscopic method detects BE based on methylated CCNA1 and VIM DNA

Swallowable Alternative to Endoscopy for Barrett’s Esophagus Detection

A swallowable balloon device has been developed to obtain samples from the lower esophagus – samples which then undergo assay of combined CCNA1and VIM DNA methylation to detect Barrett’s esophagus metaplasia, according to a study published online January 17 in Science Translational Medicine.

Helen R. Moinova, PhD, from the Case Western Reserve University in Cleveland, and colleagues developed a well-tolerated swallowable, encapsulated balloon device that was able to selectively sample the distal esophagus within five minutes, and was further engineered to progress toward non-endoscopic esophageal screening. The authors had ascertained regions targeted for recurrent aberrant cytosine methylation in BE with genome-wide screening, identifying high-frequency methylation within the CCNA1 locus. CCNA1 DNA methylation was assessed as a BE biomarker in cytology brushings of the distal esophagus from 173 individuals with or without BE.


The researchers found that for discriminating BE-related metaplasia and neoplasia cases versus normal individuals, CCNA1 DNA methylation had an area under the curve of 0.95, which was identical to that of VIMDNA methylation. The resulting two biomarker panel (combining CCNA1 and VIM DNA methylation) had sensitivity and specificity of 95 and 91 percent, respectively. In an independent validation cohort of 149 individuals, these results were replicated. Tests of CCNA1 plus VIM DNA methylation detected BE metaplasia with 90.3 and 91.7 percent sensitivity and specificity, respectively, in balloon samples from 86 individuals.

“Combining the balloon sampling device with molecular assays of CCNA1 plus VIM DNA methylation enables an efficient, well-tolerated, sensitive, and specific method of screening at-risk populations for BE,” the authors write.

Several authors disclosed having been awarded patents and having pending patents. Several authors disclosed ties to the pharmaceutical and medical device industries.

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