Large Multi-Center Study Demonstrates Significant Increase in Detection of Esophageal Pre-Cancer With Use of WATS3D Biopsy

HONOLULU, HI--(Marketwired - Oct 21, 2015) -  CDx Diagnostics announced today new data from a prospective multi-center study of more than 12,800 patients demonstrating a significant increase in detection of esophageal pre-cancer, including Barrett's esophagus and dysplasia, with the use of WATS3D biopsy, a three dimensional computer-assisted biopsy system, in community-based settings. The results were announced during a podium presentation today at the American Gastroenterology (ACG) 2015 Annual Scientific Meeting, taking place in Honolulu, Hawaii, from October 16 - 21, 2015.

The study, "Transepithelial Brush Biopsies With Computer-Assisted 3-Dimensional Analysis Markedly Improve Detection of Barrett's Esophagus and Dysplasia: Interim Analysis From a Prospective Multi-Center Community-Based Study," found that the adjunctive use of WATS^3D uncovered an additional 2,570 non-dysplastic Barrett's esophagus and 213 cases with dysplasia that were undetected with four-quadrant forceps biopsies alone. The augmented yield of adding WATS^3D biopsy to the standard biopsy approach was 153% for Barrett's esophagus and 242% for dysplasia.

"The findings from this broad study further validate and confirm the benefits of adopting the WATS^3D biopsy within the clinical setting," said Michael S. Smith, MD, MBA, Medical Director of the Esophageal Program and Associate Professor of Medicine at the Lewis Katz School of Medicine at Temple University, and senior author of the study. "By adding WATS^3D, the sampling was able to identify areas of concern that would otherwise go undetected, ultimately helping us to improve the care of patients with Barrett's esophagus and even save lives."

With more than 12,800 patients, this study enrolled cases with forceps and WATS^3D biopsy data results from June 2013 to July 2015 and is the largest WATS^3D sample to date. From the analysis, the most common endoscopic indications detected were reflux and Barrett's esophagus.

"This study underscores the importance and value of using WATS^3D biopsy to identify esophageal pre-cancer often missed by standard sampling methods," said Mark Rutenberg, Chairman and CEO of CDx Diagnostics. "These results strengthen our growing understanding of the benefits associated with WATS^3D and we look forward to continuing to deliver innovative technology and clinical insights to the endoscopy community."

The WATS^3D biopsy samples a large tissue area and its computer analysis integrates over 100, one-micron thick optical slices to form a single three dimensional image in which potential abnormality is highlighted to the pathologist.

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.^{1, 2} 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.