CDx Diagnostics to Present New Data Demonstrating Increased Detection of Esophageal Pre-Cancer Using WATS3D

SUFFERN, NY--(Marketwired - Oct 14, 2015) -  CDx Diagnostics today announced the presentation of results from a prospective multi-center study demonstrating that the WATS^3D three dimensional computer-assisted biopsy system markedly increased the detection of esophageal pre-cancer in a community-based setting. Including more than 12,000 patients, the results from this large study will be unveiled during a podium presentation at the American College of Gastroenterology (ACG) 2015 Annual Scientific Meeting, taking place in Honolulu, Hawaii, from October 16 -21, 2015.

The WATS^3D biopsy collects a wide area, disaggregated tissue specimen of the entire thickness of the suspect epithelium. While standard forceps biopsy testing is highly random and may leave a large mucosal area unsampled, 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. In clinical trials, adjunctive use of CDx Diagnostics' WATS^3D biopsy significantly increased the detection of Barrett's esophagus and dysplasia.^{1, 2} Most recently, a study published in the American Journal of Gastroenterology found the use of WATS^3D for the diagnosis of Barrett's esophagus associated dysplasia has a significantly higher rate of inter-observer agreement than published estimates for standard manual microscopic assessment.³

"We look forward to sharing these results with the gastroenterology community, providing support to the growing clinical evidence related to the use of the WATS^3D biopsy," said Mark Rutenberg, Chairman and CEO of CDx Diagnostics. "This study was designed to highlight and confirm the adjunctive benefit of WATS^3D to the use of standard forceps biopsy, and ultimately help increase the yield of detection of both Barrett's esophagus and dysplasia in a community setting."

Below is a highlighted key oral presentation during the conference:

WATS^3D Biopsy Oral Presentation
Wednesday, October 21, 7:00 - 7:10 AM
Kalakaua Ballroom A
Erkanda P. Ikonomi, MD
Internal Medicine Resident, Temple University Hospital, Philadelphia, Pa.

"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"

To learn more about the WATS^3D biopsy, please visit the CDx Diagnostics booth #1023 throughout ACG.

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.
³  Vennalaganti P, Kanakadandi V, Gross S et al. Inter-Observer Agreement among Pathologists Using Wide-Area Transepithelial Sampling With Computer-Assisted Analysis in Patients With Barrett's Esophagus. Am J Gastroenterol 2015;110:1257-60.