January 18, 2018
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Swallowable device detects pre-cancerous Barrett’s esophagus

Researchers have developed a test for early detection of an esophageal adenocarcinoma precursor lesion that uses a swallowable balloon to collect DNA samples from the bottom of the esophagus, according to a report published in Science Translation Medicine.

Early detection can help prevent esophageal adenocarcinoma (EAC), however, that has traditionally required an endoscopy, which is both expensive and invasive. Clinicians can use the new device, developed by Amitabh Chak, MD, of the Case Western Reserve School of Medicine and University Hospitals Cleveland Medical Center and colleagues, in a 5-minute, outpatient test to detect Barrett’s esophagus (BE), according to a press release.

“Symptoms of [BE], such as heartburn, can also be commonly seen in individuals who have acid reflux disease without BE. These symptoms can easily be treated by over the counter medications, so people often don’t get tested for BE, particularly by an invasive test such as endoscopy,” Chak said in the press release. “As a result, when individuals develop EAC, 95% of the time the presence of the prior [BE] was undetected and unknown. We wanted an easier, less costly test that could provide a practical way for screening and early detection of individuals with BE, who can then be followed closely to prevent development of EAC.”

Instead of undergoing an endoscopy, patients can swallow a pill-sized capsule attached to a thin catheter. Once the capsule reaches the stomach, a balloon is inflated and maneuvered to swab the lower esophagus, where BE typically begins. The balloon is then deflated, and the capsule is retrieved through the mouth, according to the press release.

In clinical trials, 82% of patients reported little to no anxiety, pain or choking, and 95% said they would recommend the test to others, according to the press release.

Helen R. Moinova, PhD, of the department of medicine at Case Western Reserve University and University Hospitals Cleveland Medical Center, led a parallel study to identify DNA changes that could help diagnose BE. Using DNA collected from 300 esophagus endoscopy samples, researchers identified two genes, VIM and CCNA1, that were chemically modified by DNA methylation in BE. The test was 90% accurate in detecting BE or recognizing a normal esophagus, per the press release.

A clinical trial of 86 patients who underwent the swallowable balloon test was similarly successful in detecting BE with more than 90% accuracy.

“Having two accurate biomarkers increases confidence in our ability to correctly diagnose [BE],” Moinova said in the press release. “Taken together, our findings show that non-endoscopic balloon sampling paired with molecular tests for the methylated VIM and CCNA1 biomarkers is effective in addressing the need for simple, non-invasive, safe and accurate [BE] screening.” – by Alex Young

Disclosures: The authors report no relevant financial disclosures.