Adjunctive Use of WATS3D Improves Diagnostic Yield of IM and Dysplasia Missed by Random Forceps Biopsy
SUFFERN, N.Y., January 17, 2023 (PR NEWSWIRE) -- CDx Diagnostics, Inc., developer of the WATS3D AI Platform for the detection and surveillance of Barrett's esophagus (BE) and dysplasia, announced the publication of a new study, Utility of WATS-3D as an Adjunct to Forceps Biopsies in Surveillance of Barrett’s Patients Post Endoscopic Eradication Therapy, in the American Society for Gastrointestinal Endoscopy (ASGE) journal iGIE by authors F. Scott Corbett MD, FASGE, Robert D. Odze MD, and Matthew J. McKinley MD. The efficacy of WATS3D has been demonstrated in numerous studies for both the screening and surveillance of BE and dysplasia, both long and short segment. This new study highlights the utility of WATS3D, - concluding that it increases the diagnostic yield of Intestinal Metaplasia (IM) and dysplasia in BE patients after ablation or endoscopic eradication therapy when used as an adjunct to forceps biopsy (FB) sampling. The WATS3D adjunctive yield for detection of residual/recurrent IM or dysplasia was 52.5% and 91.5%, respectively.
The WATS3D AI Platform collects a wide area, disaggregated tissue specimen of the entire thickness of the epithelium being tested. This unique tissue specimen is then subjected to specialized, 3-dimensional AI-powered analysis to identify any abnormal cells for presentation to an expert GI pathologist.
"After undergoing ablation, the lining of the esophagus is revitalized. Even the slightest signs of residual or recurrent IM and dysplasia can be difficult to detect with the naked eye, and standard protocols used for obtaining tissue only sample a small fraction of the mucosa. WATS3D provides physicians with the ability to detect even the most elusive metaplasia in the tubular esophagus, “said lead author F. Scott Corbett, MD, FASGE, of Florida Digestive Health Specialists. “The study shows that the WATS3D AI platform picks up IM and dysplasia even when no endoscopic evidence of Barrett’s remains after ablation therapy - offering clinicians an additional advantage in post-ablation to help ensure that all potentially precancerous tissue has been fully eradicated, improving the standard of post-ablation surveillance and ultimately patient care.”
In the study, data were examined from 2 large registries of community practices that prospectively evaluated BE surveillance using both standard FB sampling combined with WATS-3D. Comprising the study cohort were 1114 consecutive BE patients (mean age, 68.9; men 68.1%, women 31.9%) who had EET. The adjunctive (and absolute) increased yield of WATS-3D for detection of IM and dysplasia was evaluated according to the extent of endoscopic residual BE.
The highest adjunctive yield for detection of IM (260%) occurred in patients without any gross endoscopic evidence of residual or recurrent BE. The absolute yield for IM and dysplasia detection was 16% and 4.4%, respectively, and dysplasia detection was significantly greater in patients with visible BE compared with those with no endoscopic evidence of residual BE. Of 29 patients with high-grade dysplasia or esophageal adenocarcinoma detected by WATS-3D, FB sampling missed 11, including 7 where FB sampling did not detect any IM.
“With this study, WATS3D closes the loop in the Barrett’s care continuum – providing evidence for physicians that WATS3D is a single AI-powered platform that can be added for the reliable detection of Barrett’s and dysplasia during endoscopy screening, surveillance, and post-ablation therapy," said William Huffnagle, CEO of CDx Diagnostics. “This powerful technology provides clinicians with the advantage they’ve been looking for to identify and combat esophageal precancer as we move closer to our ultimate goal of true cancer prevention."
About CDx Diagnostics
CDx Diagnostics’ mission of Empowering Physicians with Innovative Technology to Prevent Esophageal Cancer, One Patient at a Time is accomplished through a proprietary diagnostic platform. This combination of technology synthesizes computer imaging, artificial intelligence, molecular biology and three-dimensional cytopathology to detect precancerous changes earlier and more reliably than prior methods. CDx tests require only a few minutes of practice time, are highly cost effective, widely reimbursed, and address a recognized critical gap in the current diagnostic standard of care. Routine clinical use of CDx testing has detected thousands of cancers and precancerous conditions that otherwise would have been missed in time for effective treatment. CDx Diagnostics is a Galen Partners portfolio company.