New study shows that WATS3D increases diagnostic yield of dysplasia in Barrett’s esophagus, regardless of segment length


SUFFERN, N.Y. (August 2, 2023) — CDx Diagnostics, Inc., 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, Benefit of Adjunctive Wide Area Transepithelial Sampling with 3- Dimensional Computer-Assisted Analysis Plus Forceps Biopsy Based on Barrett’s Esophagus Segment Length, 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.

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

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.

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

Co-author, Dr. 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 Dr. Vivek Kaul, Segal-Watson Professor of Medicine, Division of Gastroenterology & Hepatology, University of Rochester Medical Center.

8471 patients (52.5% male, mean age 53 years) were enrolled from two registry studies. All patients in the study were either being screened or were 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," said 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."

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

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.


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