A newly published study says that adjunctive use of the CDx Diagnostics WATS3D tissue sampling and analysis system increases the detection of both Barrett’s esophagus and esophageal dysplasia by over 80%.
CDx Diagnostics, developer of WATS3D, or Wide Area Transepithelial Sampling with 3D Tissue Analysis for the detection and surveillance of Barrett’s esophagus, has announced results from a study published in the latest issue of United European Gastroenterology Journal. The multicenter prospective 4000 patient study also features in the American Society for Gastrointestinal Endoscopy (ASGE)’s Scope Tech Talk video series.
Gastroenterologists perform more than five million upper endoscopies each year on patients with chronic heartburn and Barrett’s esophagus in an effort to find precancerous cells before they can progress to cancer (Esophageal adenocarcinoma). A major problem with this strategy is that endoscopists had hitherto relied on taking small random forceps biopsies at 1-2 cm intervals to find these abnormal cells, leaving more than 96% of the endoscopically suspect area completely untested.
CDx Diagnostics’ WATS3D 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. WATS3D enables doctors to rapidly collect a sample from a much larger surface area of the esophagus. The system combines a larger sampling area with patented 3D imaging and expert cytopathology. If precancerous cells are present, they can now be easily detected and removed or destroyed before they become cancerous – essentially preempting esophageal cancer.
The multicenter prospective trial was conducted at 25 community-based gastrointestinal (GI) centers across the United States. In the study, 4,203 patients were tested for esophageal disease. The findings show that with the inclusion of WATS3D overall detection of Barrett’s increased by 83%, while the detection of dysplasia increased by 88%. The study concludes that the sampling error can be improved dramatically with use of this adjunctive technique.
“Without WATS3D, gastroenterologists are forced to rely on chance, hoping that one of their small random forceps biopsies will happen to land on a highly focal area of precancer that may exist in their patient’s esophagus,” said Mark Rutenberg, Founder and CEO of CDx Diagnostics, the developer of the WATS3D diagnostic system.
“Now that we can more easily treat esophageal precancer through endoscopic ablation, the remaining obstacle to preventing the most rapidly growing cancer in the US is to more reliably identify those GERD and Barrett’s patients with these still harmless but precancerous changes so that we can treat them in time to prevent their progression to adenocarcinoma. These results clearly demonstrate that WATS3D can very effectively help to fill that critical gap in current routine GI care.”
“These data confirm findings from previous clinical trials showing that WATS3D biopsy significantly increases the detection rate of Barrett’s Esophagus as well as precancerous changes in esophageal tissue in GERD patients,” said Seth Gross, MD, lead investigator. “Ultimately, WATS3D revolutionary technology is making esophageal cancer a potentially preventable disease.”
“This study exhibits the fundamental limitation with standard forceps biopsies in the setting of Barrett’s diagnosis and surveillance and sheds light on the ‘sampling error’ phenomenon that may provide false reassurance to both patients and GI professionals,” said Dr. Vivek Kaul, Segal-Watson Professor of Medicine and Chief of the Division of Gastroenterology and Hepatology at the University of Rochester Medical Center.
“These results clearly demonstrate that the wide-area sampling and expert analysis aspects of WATS3D technology can effectively help fill the information gap in diagnosis and surveillance for patients with Barrett’s esophagus.”
Source: Globe Newswire