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


October 14, 2015 - Suffern, NY

CDx Diagnostics today announced the presentation of results from a prospective multi-center study demonstrating that the WATS3D 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 WATS3D 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 WATS3D 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' WATS3D 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 WATS3D 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 WATS3D biopsy," said Mark Rutenberg, Chairman and CEO of CDx Diagnostics. "This study was designed to highlight and confirm the adjunctive benefit of WATS3D 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:

WATS3D 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 WATS3D biopsy, please visit the CDx Diagnostics booth #1023 throughout ACG.

About CDx Diagnostics and the WATS3D Biopsy
CDx Diagnostics' mission is to provide doctors with the most powerful diagnostic technology to help prevent cancer before it can start.

CDx Diagnostics' WATS3D 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' WATS3D biopsy significantly increased the detection rate of both Barrett's esophagus and esophageal dysplasia. The high sensitivity of WATS3D 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 WATS3D, 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.

Contact:
Chantal Beaudry or Amy Feldman for CDx Diagnostics
cbeaudry@lazarpartners.com
afeldman@lazarpartners.com
212-867-1762

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