DETECT-ME: Swallowable Sponge Test for Barrett’s Esophagus Screening

A swallowable capsule-sponge device paired with a DNA methylation biomarker panel detected Barrett’s esophagus (BE) with 90% sensitivity and 86% specificity in the prospective, multicenter DETECT-ME study. The late-breaking results were presented at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting in Nashville, Tennessee.¹

Nicholas Shaheen, MD, MPH, told HCPLive an estimated 70% to 90% of patients eligible for BE screening in the US never undergo it, and EAC incidence has risen roughly fivefold over the past 4 decades. He said DETECT-ME was designed to test whether nonendoscopic sampling could move screening out of the endoscopy unit and into primary care.

“Can we democratize screening so that it isn’t tethered to an endoscopy unit? That’s the bigger question that we’re asking with DETECT-ME,” said Shaheen.

DETECT-ME Study Design and Methylation Biomarker Panel

DETECT-ME enrolled patients at 18 sites, including high-risk patients undergoing screening upper endoscopy and patients with known BE presenting for surveillance or endoscopic eradication therapy.¹ Participants underwent sampling with the EndoSign cell collection device before esophagogastroduodenoscopy (EGD), which served as the reference standard.

The device consists of an encapsulated sponge attached to a string. After the capsule dissolves in the stomach, the expanded sponge is withdrawn through the esophagus, collecting cells. Investigators assessed DNA methylation at 654 BE-associated regions and 1561 reference regions, using a rank-based score to estimate the likelihood of BE.¹

The primary analysis population included 324 patients: 181 with BE and 143 without, with 156 undergoing screening and 168 undergoing surveillance or eradication therapy.¹ Shaheen said patients with known BE were included to enrich the study population, since only about 10% of a typical screening population has the condition.

Capsule-Sponge Sensitivity by Barrett’s Segment Length and Dysplasia

Overall sensitivity was 90% (163/181; 95% CI, 84%-94%), and specificity was 86% (123/143; 95% CI, 79%-91%). Sensitivity increased with segment length: 82% (95% CI, 73%-89%) for short-segment BE and 99% (95% CI, 94%-100%) for long-segment BE.¹

Sensitivity was 100% (46/46) among patients with any dysplasia or EAC and 87% among those with nondysplastic BE.¹ Shaheen said no patient with 3 cm or more of BE was missed, and most false negatives occurred in patients with about 1 cm of disease, the group at lowest cancer risk.

Sensitivity was lower in the high-risk screening group (69%) than in patients with known BE (92%), which the investigators attributed to the shorter BE segments in the screening group.¹

Tolerability and Path to Primary Care Barrett’s Screening

Cell collection succeeded in 95% of participants, with no device-related adverse events.¹ The mean tolerability score was 2.0 on a 10-point scale, with 82% rating tolerance as excellent and 95.5% as acceptable. Overall, 81% of participants said they would be willing to repeat the procedure.¹

Shaheen said tolerability is essential for broad adoption. He envisions gastroenterologists partnering with primary care practices to offer the test during routine visits and refer only positive patients for EGD, increasing the yield of each endoscopy.

“We have a failed paradigm now, and so we’ve got to think differently,” he explained. “If we keep doing what we’ve always done, we’re going to keep getting what we’ve always got.”

ACG guidelines support screening in patients with chronic reflux and additional risk factors, and endorse nonendoscopic capsule devices combined with a biomarker as an acceptable alternative to endoscopy.²

Editors’ note: Shaheen reports relevant disclosures with Cyted, Lucid, Phathom Pharmaceuticals, Medtronic, and others.

References

1. Shaheen NJ, et al. A prospective, multicenter cohort study of a novel methylation biomarker panel using non-endoscopic cell collection to detect Barrett’s esophagus: the DETECT-ME study. Presented at: American College of Gastroenterology 2026 Annual Scientific Meeting; October 9-14, 2026; Nashville, TN.

2. Shaheen NJ, Falk GW, Iyer PG, et al. Diagnosis and management of Barrett’s esophagus: an updated ACG guideline. Am J Gastroenterol. 2022;117(4):559-587. doi:10.14309/ajg.0000000000001680