Latest news with #WATS3D
Associated Press
24-07-2025
- Health
- Associated Press
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, 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 or contact us at [email protected]. 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 [email protected] 845-777-7000 SOURCE: CDx Diagnostics press release
Associated Press
02-05-2025
- Health
- Associated Press
CDx Diagnostics to Present WATS3D Progression Data at DDW 2025
Highlights Continued Progress in Early Detection and the Progression of Esophageal Disease SUFFERN, N.Y., May 2, 2025 /PRNewswire/ -- CDx Diagnostics announced today that new clinical data supporting the utility of the WATS3D test for Barrett's esophagus and dysplasia screening and surveillance has been selected for podium presentation at the 2025 Digestive Disease Week (DDW) in San Diego, the premier conference for gastroenterology professionals. This podium presentation, along with additional data featured in a separate poster presentation, highlights WATS3D's vital role in early detection, progression monitoring and risk assessment of patients at risk for Barrett's esophagus and esophageal cancer. WATS3D has consistently shown superior detection rates compared to conventional forceps biopsy (FB), the latter of which can miss up to 50% of cases. By sampling a broader area of mucosa and analyzing more cellular material using advanced 3D imaging, WATS3D may help gastroenterologists detect Barrett's esophagus that might otherwise go undiagnosed. Key Events at DDW 2025: Nicholas J. Shaheen, MD will deliver the podium presentation, based on a collaborative study with Dr. Michael Smith, Dr. Vivek Kaul, Mendel Singer Ph.D., and Dr. Robert Odze. 'The findings validate WATS3D's role in early detection,' said Dr. Shaheen. 'We're excited to share these results at DDW and discuss their impact on patient care.' Robert D. Odze, MD noted that 'These studies advance our understanding of the biological significance of WATS3D detected lesions and their risk of progression to cancer in Barrett's esophagus.' The new data shared at DDW 2025 from May 3-6 offers important clinical insights into the evolving role of WATS3D in Barrett's detection, surveillance and risk assessment. For more information, visit or contact us at [email protected]. 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 outcomes by detecting disease that might be missed by traditional forceps biopsies. CONTACT: Logan Garrett [email protected] 423-519-9979 View original content: SOURCE CDx Diagnostics
