Missile Defence 3D Imaging Algorithms Help Defend Against Undetected Pre-Cancer of the Esophagus

CDx Diagnostics has announced that new data from routine clinical use in a number of academic GI centers continues to support use of company's WATS3D (Wide Area Transepithelial Sample biopsy with 3-dimensional analysis), as an additional surveillance tool to increase detection of dysplasia and Barrett's Esophagus.

Barrett's Esophagus is a condition that can arise as a result of chronic gastroesophageal reflux disease (GERD) and can be a pre-cursor to esophageal cancer. The data was presented in a poster session at Digestive Disease Week® (DDW®), taking place from May 18-21, 2013.

The WATS3D biopsy is developed by CDx Diagnostics (www.cdxdiagnostics.com), the world's leader in the prevention of cancer of the oral cavity, pharynx, larynx and esophagus through early detection of their pre-cancerous precursors. Clinicians use the WATS3D biopsy instruments to collect, through minimally invasive procedures, a wide area, disaggregated tissue specimen of the entire thickness of the suspect epithelium. This unique tissue specimen is then subjected to specialized, computer-assisted laboratory analysis.

The retrospective, multicenter study (Abstract number Su1452) "Initial Multicenter Experience With Wide Area Transepithelial Esophageal Biopsy With 3D Computer Assisted Analysis for the Detection of Barrett's Esophagus," led by Seth A. Gross, M.D., Assistant Professor of Medicine at the NYU School of Medicine and Director of Endoscopy at Tisch Hospital, NYU Langone Medical Center, found that WATS3D increased detection yield of Barrett's Esophagus by 20% (9-32%, p < .05). Correlation of WATS3D and forceps biopsy results was uniformly high among all sites with an average concordance index of .88 and a range of .82-.94. In three sites that had more than 30 WATS3D tests performed or had on-site assistance, the increased detection yield of Barrett's Esophagus was an average of 46% (20%-88%, p < .05, n=75).

"These results reinforce findings from previous clinical trials showing that WATS3D biopsy significantly increased the detection rate of Barrett's Esophagus as well as precancerous changes in esophageal tissue in GERD patients," said Seth Gross M.D. "The higher yield rate at sites that had more experience with the technology suggests a modest learning curve."

Esophageal cancer is now the fastest growing form of cancer in the United States. Early detection is particularly difficult because dysplasia in Barrett's Esophagus is often inconspicuous, flat, and patchy in distribution. Studies evaluating patients undergoing esophagectomy for high-grade dysplasia have found adenocarcinoma in 43-57% of patients that was undetected at surveillance endoscopy.

"Our goal in developing WATS3D was to overcome the sampling limitations of current biopsy techniques so that healthcare professionals can detect and prevent cancer before it starts," said Mark Rutenberg, founder, chairman, and CEO of CDx Diagnostics.