New Data Presented at UEG Week Shows Use of WATS3D Significantly Increases Detection of Esophageal Pre-Cancer

BARCELONA, SPAIN--(Marketwired - Oct 27, 2015) - CDx Diagnostics today announced new data from a prospective multi-center community-based study demonstrating a significant increase in detection of esophageal pre-cancer and further validating the benefit of using the WATS3D three-dimensional computer-assisted biopsy in community-based practices. The results were announced in an oral presentation today at United European Gastroenterology (UEG) Week 2015, taking place in Barcelona, Spain from October 24-28, 2015.

Including more than 4,000 patients, the study, "Increased Detection of Barrett's Esophagus and Esophageal Dysplasia Using Transepithelial Brush Biopsy With Three Dimensional Computer-Assisted Tissue Analysis: A Prospective Multi-Site Community Based-Study," found that Barrett's esophagus was diagnosed in 594 patients by random forceps biopsies and in 799 patients by WATS^3D. Of those 799 patients, 493 were undetected when random forceps biopsies were performed. Therefore, adding WATS^3D increased the detection of Barrett's esophagus by 83.0%. 

In addition, esophageal dysplasia was found in 26 patients by random forceps biopsies and in 33 patients with the use of WATS^3D. By adding WATS^3D to the standard biopsy procedure, there was an increase in detection of esophageal dysplasia by 88.5%.

"Unlike standard biopsy testing, which can be subject to sampling error, the adjunctive use of WATS^3D can better identify and more accurately detect esophageal pre-cancer in routine screening and surveillance in endoscopic practices," said Seth Gross, MD, FACG, FASGE, Chief of Gastroenterology, Tisch Hospital; Associate Professor of Medicine, NYU Langone Medical Center; and lead author of the study.

The trial was conducted during 2012 to 2014 and included patients with symptoms of gastroesophageal reflux, suspected Barrett's esophagus and those patients with known Barrett's esophagus undergoing observation for esophageal dysplasia.

"In our continued commitment to lead in the detection and prevention of esophageal pre-cancer, we are excited to add new data to the growing body of evidence further reinforcing the benefits of WATS^3D," said Mark Rutenberg, Chairman and CEO of CDx Diagnostics. "This new data emphasizes the unparalleled advantages of using WATS^3D biopsy for the detection of Barrett's esophagus and dysplasia for physicians and patients."

Shown to significantly increase the detection of Barrett's esophagus and dysplasia, ^{1, 2} the WATS^3D biopsy samples a large tissue area and its computer analysis integrates more than 100, one-micron thick optical slides to form a single three-dimensional image in which potential abnormality is highlight to the pathologist. To learn more about the WATS^3D biopsy, please visit the CDx Diagnostics booth #18 throughout UEG Week.

About CDx Diagnostics and the WATS^3D Biopsy
CDx Diagnostics' mission is to provide doctors with the most powerful diagnostic technology to help prevent cancer before it can start.

CDx Diagnostics' WATS^3D biopsy addresses the sampling error inherent in random forceps biopsy testing of the esophagus. In just a few minutes, gastroenterologists can easily obtain a wide area, full-thickness transepithelial tissue sample for computer-assisted 3D laboratory analysis. In clinical trials, adjunctive use of CDx Diagnostics' WATS^3D biopsy significantly increased the detection rate of both Barrett's esophagus and esophageal dysplasia. The high sensitivity of WATS^3D is due to the large tissue area sampled, and the proprietary 3-Dimensionial computer imaging system that is based on an algorithm developed as part of the U.S. Strategic Defense Initiative missile defense program. To learn more about WATS^3D, visit www.WATS3D.com.

References

¹ Johanson JF, Frakes J, Eisen D et al. Computer-assisted analysis of abrasive transepithelial brush biopsies increases the effectiveness of esophageal screening: a multicenter prospective clinical trial by the EndoCDx Collaborative Group. Dig Dis Sci 2011;56:767-72.

² Anandasabapathy S, Sontag S, Graham DY et al. Computer-assisted brush-biopsy analysis for the detection of dysplasia in a high-risk Barrett's esophagus surveillance population. Dig Dis Sci 2011;56:761-6.