CDx Diagnostics receives FDA Breakthrough Device Designation for its WATS3D Test System for Esophageal Cancer

Novel AI-powered laboratory test for diagnosis of Barrett's esophagus, with or without dysplasia

SUFFERN, N.Y., July 24, 2025 (Newswire.com) – CDx Diagnostics announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for its proprietary WATS^3D diagnostic system, a ‘first-of-a-kind’ AI-powered digital pathology system using wide area transepithelial sampling for the diagnosis of Barrett’s esophagus and early neoplastic alterations in patients at risk for disease progression.

“The Breakthrough Device Designation recognizes what the volume of clinical data has shown: the WATS^3D Test improves the ability to detect dysplasia in Barrett’s esophagus, offering patients and physicians an improved method of detection of patients at risk of development of esophageal cancer,” said Robert Odze, MD, a leading gastrointestinal pathologist.

FDA granted Breakthrough Device Designation for its proprietary WATS^3D diagnostic system, a ‘first-of-a-kind’ AI-powered digital pathology system using wide area transepithelial sampling for the diagnosis of Barrett’s esophagus and early neoplastic alterations in patients at risk for disease progression.

To meet the requirements for FDA Breakthrough Device Designation, CDx Diagnostics submitted technical and clinical evidence from large multi-center studies showing that the WATS^3D Test is ‘more effective’ than the Seattle biopsy protocol for diagnosis of Barrett’s esophagus, dysplasia and esophageal cancer.

The WATS^3D Test System leverages proprietary artificial intelligence (AI) enabled algorithm for analysis of high-resolution digital pathology using novel 3-dimensional images from specimens collected using the WATS3D brush to identify precancerous and cancerous cells and assess the risk of progression to cancer.

The WATS^3D System was developed by CDx Diagnostics and is performed in the company’s CLIA-certified, CAP accredited, New York state licensed clinical laboratory in Suffern, NY.

For more information about WATS^3D and its benefits, please visit www.cdxdiagnostics.com or email us at WATS3D@cdxdiagnostics.com. 

About CDx Diagnostics
CDx Diagnostics' mission is to Empower Physicians with Innovative Technology to Prevent 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 more precisely than conventional methods. This pioneering solution has analyzed over 400,000 cases, empowering providers to identify those requiring early intervention, reduce time to treatment, and improve patient outcomes.

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.