WATS3D Significantly Boosts Barrett's Esophagus and Dysplasia Detection Rates in Landmark Clinical Study

Pivotal Multi-Center Study Highlights AI Platform's Powerful Diagnostic Impact and Ability to Enhance Patient Outcomes 

SUFFERN, N.Y., May 17, 2024 – CDx Diagnostics, Inc., developer of the WATS^3D AI Platform for the detection and surveillance of Barrett's esophagus (BE) and dysplasia, today announced the publication of a new study, Adjunctive Use of WATS-3D In Symptomatic GERD Patients Increases Detection of Barrett’s Esophagus and Dysplasia, in The American Journal of Gastroenterology. The pivotal study highlighted WATS^3D's significant impact on improving precancer detection during GERD screenings. Adding WATS^3D to these screenings resulted in the identification of 20% more Barrett's cases and doubled dysplasia diagnoses vs. biopsy alone. The WATS^3D diagnosis influenced the clinical management of over 90% of patients based on findings missed by forceps. Strikingly, 1 in 5 patients would have been unaware of their precancerous Barrett's esophagus condition without WATS^3D. 

The study, led by Nicholas J Shaheen, MD et al., evaluated 23,933 patients, where WATS^3D identified intestinal metaplasia in 19.3% and, of 240 patients with dysplasia, 107 (44.6%) that were missed by forceps biopsy. WATS^3D demonstrated 76.5% adjunctive and 18.1% absolute yield in the detection of IM in patients with endoscopic BE criteria. This resulted in care plans changing in 90.7% of WATS^3D positive but biopsy negative cases. 

Pivotal Multi-Center Study Highlights AI Platform's Powerful Diagnostic Impact and Ability to Enhance Patient Outcomes.

"Compared to forceps biopsy alone, WATS^3D identified around 20% more Barrett's cases that would've been missed. We also observed nearly double the dysplasia diagnoses,” said lead author, Dr. Shaheen, Chief, Division of Gastroenterology & Hepatology, University of North Carolina School of Medicine at Chapel Hill. 

"This represents our largest clinical study of WATS^3D to date and one of the most impactful," said Duane Dorn, CDx COO. "The landmark findings highlight how our AI imaging technology can effectively transform early detection rates and empower physicians to intervene before progression to esophageal cancer. Improving patient lives through earlier detection is the driving force behind our innovations."  

Patients with GERD frequently show columnar-lined epithelium, but forceps biopsies often fail to confirm intestinal metaplasia. WATS^3D leverages AI and 3D imaging to reliably identify precancerous cells, providing actionable insights to guide BE management. 

Visit us at the Digestive Disease Week (DDW) 2024 Annual Meeting, being held May 18-21, in Washington DC, Booth #3807, or online at  WATS3D.com to learn more.

About CDx Diagnostics
CDx Diagnostics is driven by its mission to Empower Physicians with Innovative Technology that Prevents Esophageal Cancer, One Patient at a Time. The company's proprietary diagnostic platform combines advanced computer imaging, artificial intelligence, molecular biology, and 3D cytopathology to detect precancerous changes earlier and with greater precision than conventional methods. CDx tests seamlessly integrate into physician workflows, requiring only minutes to conduct while providing highly cost-effective and widely reimbursed results. By addressing a critical gap in the current diagnostic standard of care, CDx's pioneering solutions have enabled the early detection of thousands of cancers and precancerous conditions, unlocking opportunities for timely and effective treatment. 

About WATS^3D
CDx Diagnostics’ WATS^3D addresses the major inadequacies inherent in current random forceps biopsy testing of the esophagus. In just a few minutes, endoscopists can easily obtain a wide area, full-thickness transepithelial tissue sample for computer-assisted 3D laboratory analysis by expert pathologists. In large multicenter clinical trials, WATS^3D has been found to significantly increase the detection rate of both Barrett's esophagus and esophageal dysplasia. The high sensitivity and inter-observer agreement of WATS^3D is due to the larger tissue area sampled, and the proprietary 3-Dimensionial computer imaging system that is based on an algorithm developed as part of the U.S. Strategic Defense Initiative missile defense program. To learn more about WATS^3D, visit www.wats3d.com.