CDx Diagnostics, developer of the WATS3D AI Platform for the detection and surveillance of Barrett’s esophagus (BE) and dysplasia, reported positive data in a recently published study.

The study, Benefit of Adjunctive Wide Area Transepithelial Sampling with 3- Dimensional Computer-Assisted Analysis Plus Forceps Biopsy Based on Barrett’s Esophagus Segment Length, was published in the American Society for Gastrointestinal Endoscopy (ASGE) journal GIE (Gastrointestinal Endoscopy) by authors Arvind J. Trindade, MD, Robert D. Odze, MD, FRCPc, Michael S. Smith, MD, MBA and Vivek Kaul, MD, FASGE. 

Regardless of segment length, WATS3D is highly effective at increasing the diagnostic yield of intestinal metaplasia and dysplasia.

“WATS3D has previously shown diagnostic effectiveness for patients with known or suspected BE,” says Trindade, the lead author of the study, and regional director of Endoscopy, Northwell Health. “This new study focuses on WATS3D performance in short versus long segment esophageal columnar-lined mucosa.”

About the WATS3D AI Platform

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, three-dimensional AI-powered analysis to identify any abnormal cells for presentation to an expert GI pathologist.

Co-author, Michael S. Smith, chief of Gastroenterology & Hepatology, Mount Sinai West & Mount Sinai Morningside Hospitals, noted, “This study demonstrated that when added as an adjunct to forceps biopsies, WATS3D is highly effective at increasing the diagnostic yield of intestinal metaplasia and dysplasia for the screening and surveillance of patients with esophageal columnar mucosa regardless of segment length.”

“The findings highlight the value of WATS3D as a reliable, adjunctive tool for endoscopists looking to enhance the diagnostic yield for detecting intestinal metaplasia and dysplasia in their patients with suspected or known Barrett’s in order to pre-empt neoplastic change and improve patient management and outcomes,” added senior author Vivek Kaul, MD, Segal-Watson Professor of Medicine, Division of Gastroenterology & Hepatology, University of Rochester Medical Center.

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There were 8,471 patients (52.5% male, mean age 53 years) who were enrolled in two registry studies. All patients in the study were either screened or surveyed for BE by endoscopy with both FB and WATS3D. The adjunctive and absolute yields of WATS3D were calculated according to the length of the patient’s BE segment. Intestinal metaplasia and dysplasia detection both increased markedly with the adjunctive use of WATS3D in all segment lengths of Barrett’s esophagus, both short and long. (overall adjunctive yields were 128% and 145% respectively for detection of dysplasia).

“This study underscores the clinical versatility of WATS3D for the detection of Barrett’s and dysplasia,” says William Huffnagle, CEO of CDx Diagnostics. “The utility of this powerful technology provides clinicians with the practical advantage they’ve been looking for to identify and combat preneoplastic esophageal pathology.”

Smith, Kaul, and Odze are paid consultants with CDx Diagnostics, Inc. None of the consultants received compensation for their work on this study.