Novel AI-powered laboratory test for diagnosis of Barrett's esophagus, with or without dysplasia
SUFFERN, NEW YORK / ACCESS Newswire / July 24, 2025 / CDx Diagnostics announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for its proprietary WATS3D 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 WATS3D 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.
To meet the requirements for FDA Breakthrough Device Designation, CDx Diagnostics submitted technical and clinical evidence from large multi-center studies showing that the WATS3D Test is 'more effective' than the Seattle biopsy protocol for the diagnosis of Barrett's esophagus, dysplasia and esophageal cancer.
"With data from greater than 23,000 patients, the WATS3D Test continues to demonstrate its potential to detect early-stage neoplastic disease that might be missed with conventional biopsies," said Karen Hoffman, MD, Director of R&D at CDx Diagnostics. "This designation recognizes the science behind our platform and supports our ongoing efforts to improve early detection of patients at risk."
The WATS3D 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 WATS3D 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, visit www.cdxdiagnostics.com or contact 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. CDx Diagnostics is changing the landscape of cancer prevention and diagnosis through innovative AI-driven digital pathology solutions developed and performed in the company's CLIA-certified, CAP accredited clinical laboratory in Suffern, New York. The company's first advanced diagnostic test- the WATS3D Test system powered by the WATS3D Esophageal AI Algorithm - has FDA Breakthrough Device Designation for the diagnosis of Barrett's esophagus (BE), with and without dysplasia.
About the WATS3D Test System
The WATS3D Test system is an AI-powered digital pathology test system that helps prevent the progression of neoplasia via more effective identification of Barrett's esophagus (BE), low-grade dysplasia (LGD), high-grade dysplasia (HGD), and esophageal adenocarcinoma (EAC). Developed and performed by CDx Diagnostics, the WATS3D Test leverages artificial intelligence (AI) enabled analysis using the WATS3D Esophageal AI Algorithm and 3D digital imaging of samples collected using a WATS3D brush to identify precancerous and cancerous cells and evaluate the risk of progression to cancer. The WATS3D Test has been used to analyze over 400,000 patient samples to identify those requiring earlier intervention, reduce time to treatment, and improve patient outcomes.
Contact Information
William Standwill
Marketing
marketingdepartment@cdxdiagnostics.com
845-777-7000
SOURCE: CDx Diagnostics
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/biotechnology/cdx-diagnostics-receives-fda-breakthrough-device-designation-for-its-wats3d-test-syst-1052576
