Cyted Health today announced positive clinical validation data from DETECT-ME, a prospective, multicenter study of the EndoSign® Barrett’s Esophagus (BE) Test. Conducted at 18 U.S. clinical sites, the study compared Cyted’s non-endoscopic, methylation-based test directly against standard endoscopy and biopsy, using samples collected with the FDA 510(k)-cleared EndoSign® Cell Collection Device.
The data was presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Nashville, Tennessee during the Wednesday October 14, 2026 Plenary Session 4A: Esophagus / Practice Management, #64: 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 (Late-Breaking Abstract).
Barrett’s esophagus, the only known precursor to esophageal adenocarcinoma, is dramatically underdiagnosed. The challenge is not confirming Barrett’s esophagus with endoscopy; it is that many at-risk patients never reach endoscopy in the first place. DETECT-ME validates a different model: a cell collection procedure, performed without sedation, combined with molecular testing in Cyted’s CLIA-certified, CAP-accredited U.S. laboratory to identify the patients who should be referred for endoscopy.
Key findings from 324 participants:
- 90% overall sensitivity and 86% specificity for Barrett’s esophagus
- 100% sensitivity for dysplasia and esophageal adenocarcinoma, the patients for whom early detection matters most
- 99% sensitivity for long-segment Barrett’s esophagus
The study achieved 95% sampling success with no device-related adverse events, while 82% of patients rated tolerability as excellent.
“Diagnosing Barrett’s esophagus with endoscopy isn’t where things break down. The gap is that too many people at risk never reach an endoscopy in the first place,” said Marcel Gehrung, CEO and Co-Founder of Cyted Health. “With DETECT-ME, we now have U.S. validation of a simpler, more accessible way into the diagnostic process, so we can reach patients sooner, before their condition progresses and while surveillance and treatment can still have a real impact.”
“The DETECT-ME results are encouraging because the test performed best exactly where it matters most: in long-segment Barrett’s and in patients with dysplasia or early cancer, the groups at highest risk of death from esophageal adenocarcinoma,” said Nick Shaheen, Professor of Medicine & Senior Associate Dean for Clinical Research at the University of North Carolina School of Medicine, and member of Cyted Health Scientific Advisory Board. “Participants tolerated the capsule sponge well, and sampling succeeded in over 95%. Together, these findings suggest that capsule-sponge sampling with methylation testing could open a path to screening many more at-risk people and, ultimately, to reducing deaths from esophageal cancer.”
The EndoSign® Barrett’s Espophagus Test does not replace diagnostic endoscopy. A “Barrett’s Signal Detected” result requires confirmatory evaluation by endoscopy, allowing the test to help direct endoscopy resources toward the patients most likely to benefit.
About Cyted Health
Cyted Health believes early and accurate identification of esophageal disease can change the clinical clock – bringing clarity sooner, so clinicians can act earlier with greater impact.
The company is dedicated to improving early detection and prevention of esophageal adenocarcinoma. Its platform combines minimally invasive cell collection with high-resolution molecular analysis to detect early biological changes associated with Barrett’s esophagus and cancer. Cyted Health has built a robust portfolio of peer-reviewed publications and conducted over 40,000 tests using its diagnostic platform.
Cyted Health cares about restoring time when medicine does its best work: clearer answers, more informed decisions, and fewer patients left waiting in anxiety, so more people can get back to life, facing forward with confidence not concern.
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