CDx Diagnostics announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its proprietary WATS3D diagnostic system, marking a significant advancement in esophageal cancer detection. The AI-powered digital pathology system represents a first-of-a-kind approach using wide area transepithelial sampling for diagnosing Barrett's esophagus and early neoplastic alterations in patients at risk for disease progression.
Superior Detection Capabilities Demonstrated
The designation follows submission of technical and clinical evidence from large multi-center studies demonstrating that the WATS3D Test is more effective than the Seattle biopsy protocol for diagnosing Barrett's esophagus, dysplasia, and esophageal cancer. "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.
The clinical validation encompasses data from greater than 23,000 patients, providing substantial evidence of the system's diagnostic capabilities. "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.
Advanced AI-Powered Technology Platform
The WATS3D Test System leverages proprietary artificial intelligence-enabled algorithms for analysis of high-resolution digital pathology using novel 3-dimensional images from specimens collected using the WATS3D brush. This technology enables identification of precancerous and cancerous cells while assessing the risk of progression to cancer.
The system specifically targets the identification of Barrett's esophagus, low-grade dysplasia, high-grade dysplasia, and esophageal adenocarcinoma. The AI-powered analysis utilizes the WATS3D Esophageal AI Algorithm combined with 3D digital imaging to evaluate cellular changes that may indicate malignant transformation.
Extensive Clinical Experience and Laboratory Operations
The WATS3D Test has been used to analyze over 400,000 patient samples, demonstrating its potential to identify patients requiring earlier intervention, reduce time to treatment, and improve patient outcomes. The system is developed and performed in CDx Diagnostics' CLIA-certified, CAP accredited, New York state licensed clinical laboratory in Suffern, NY.
The company's mission focuses on empowering physicians with innovative technology to prevent esophageal cancer through AI-driven digital pathology solutions. The WATS3D Test system, powered by the WATS3D Esophageal AI Algorithm, now holds FDA Breakthrough Device Designation for the diagnosis of Barrett's esophagus with and without dysplasia.
Clinical Impact and Future Implications
The Breakthrough Device Designation recognizes the science behind the platform and supports ongoing efforts to improve early detection of patients at risk for esophageal cancer progression. The designation acknowledges the system's potential to address unmet medical needs in esophageal cancer screening and diagnosis, particularly in identifying early-stage neoplastic disease that conventional biopsy methods might miss.
The WATS3D diagnostic system represents a significant technological advancement in cancer prevention and diagnosis, offering healthcare providers enhanced capabilities for identifying patients at risk of esophageal cancer development through more effective detection of Barrett's esophagus and associated dysplastic changes.
