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WATS3D Markedly Improves Detection of Esophageal Dysplasia and Barrett’s Esophagus in 12,899 Patient Study in the “Real World” Practice setting of 58 Community-Based Gastroenterologists

December 20, 2018

- New Study with Largest Data Set to Date Demonstrates that Adjunctive Use of WATS3D Significantly Increases Detection of Esophageal Precancer -

- Study Published in Diseases of the Esophagus -

SUFFERN, N.Y., Dec. 20, 2018 (GLOBE NEWSWIRE) -- CDx Diagnostics today announced the publication of new data demonstrating that the addition of WATS3D (Wide Area Transepithelial Sampling with 3D Tissue Analysis) to standard targeted and random forceps biopsy (FB) markedly increases the overall detection of esophageal dysplasia (ED) by 242% and the overall detection of Barrett’s esophagus (BE) by 153% in patients undergoing BE screening and surveillance. These data, which were gathered from 58 community-based endoscopists at 21 clinical sites, and represent the largest collection of patients in a community setting evaluated with WATS3D to date, have been published in Diseases of the Esophagus.1

“The results of this prospective study confirm that using WATS3D with forceps biopsies significantly increases detection of both ED and BE,” said Michael S. Smith, MD, MBA, lead author and Chief of Gastroenterology and Hepatology at Mount Sinai West and Mount Sinai St. Luke’s Hospitals in New York City. “With the results of this and other published studies, the evidence is overwhelming that we should be using WATS3D along with forceps biopsies to evaluate all of our BE patients. We should not rely solely on techniques like forceps sampling, which clearly miss evidence of progression toward esophageal adenocarcinoma, an often fatal disease.” Click to tweet

BE and esophageal dysplasia are precancerous conditions that are associated with progression to esophageal adenocarcinoma (EAC), one of the most rapidly rising cancers in America, and a cancer that has a poor survival rate of only 15-20%.2 Consequently, screening for and surveillance of chronic heartburn patients for the presence of BE and dysplasia plays a critical role in the prevention of EAC. However most of these precancerous abnormalities are not endoscopically visible and since the standard FB protocol used to detect them (the “Seattle Protocol”) only randomly examines about 4% of the esophageal area of clinical interest, is subject to considerable sampling error and therefore has low sensitivity.2,[3] Previous studies with WATS3D have shown a significantly increased rate of both BE and ED detection when used as an adjunct to both targeted and random 4-quadrant FB.

The current study evaluated adjunctive use of the WATS3D system that uses a three-dimensional computer image analysis system to facilitate microscopic examination of the thick (150 microns) complex wide area histological/cytological tissue specimen obtained by a transepithelial sampling tissue sampling brush optimized for EGD. The study was conducted at 21 community gastroenterology centers between June 2013 and July 2015 and included 58 endoscopists who examined 12,899 patients with GERD, or established BE patients with salmon-colored mucosa in the tubular esophagus, a finding suspicious for BE, who were sampled using both WATS3D and FB. The increase in detection rates using WATS3D in addition to FB was calculated by comparing the number of cases with disease found only on WATS3D to the number of cases where it was found on FB.

“The prior standard of care forced gastroenterologists to rely on chance, hoping that one of their small random forceps biopsies will happen to land on a highly focal area of advanced precancer that may exist in their patient’s esophagus,” said Mark Rutenberg, Founder and CEO of CDx Diagnostics, the developer of the WATS3D diagnostic system. “Now that we can more easily treat esophageal precancer though endoscopic ablation, the remaining obstacle to preventing the most rapidly growing cancer in the U.S. is to more reliably identify those GERD and Barrett’s patients with these still harmless but advanced precancerous changes so that we can treat them in time to prevent their progression to adenocarcinoma. This data from community-based gastroenterology practices reinforces the need for a better tool for both screening and surveillance of BE and ED. These results clearly demonstrate that WATS3D can very effectively help to fill that critical gap in current routine GI care.”

About WATS3D CDx Diagnostics’ WATS3D addresses the major inadequacies inherent in current random forceps biopsy testing of the esophagus. In just a few minutes, endoscopists can easily obtain a wide area, full-thickness transepithelial specimen for computer-assisted 3D laboratory analysis prior to diagnosis by a pathologist. In large multicenter clinical trials, WATS3D has been found to significantly increase the detection rate of both Barrett’s esophagus and esophageal dysplasia. The high sensitivity and inter-observer agreement of WATS3D is due to the larger tissue area sampled, and the proprietary 3-Dimensional 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.

About CDx Diagnostics CDx Diagnostics’ mission is to provide clinicians with easily implemented, cost effective tools to preempt cancer through enhanced detection of precancerous change. This is accomplished by a proprietary diagnostic platform that synthesizes computer imaging, artificial intelligence, molecular biology and three-dimensional cytopathology to detect precancerous change earlier and more reliably than prior methods. CDx tests require only a few minutes of practice time, are highly cost effective, widely reimbursed, and address a recognized critical gap in the current diagnostic standard of care that results in thousands of otherwise unnecessary cancer deaths each year. Routine clinical use of CDx testing in the oral cavity and esophagus has prevented thousands of cancers, and application of the CDx diagnostic platform to prevent cancers of the throat, bile duct, liver, pancreas, stomach, and colon is currently in progress.

Contact: Chantal Beaudry or John Guerriero for CDx Diagnostics cbeaudry@lazarpartners.comjguerriero@lazarpartners.com 212-867-1779

_____________________________1 M S Smith, E Ikonomi, R Bhuta, N Iorio, R D Kataria, V Kaul, S A Gross, US Collaborative WATS Study Group; Wide-area transepithelial sampling with computer-assisted 3-dimensional analysis (WATS) markedly improves detection of esophageal dysplasia and Barrett’s esophagus: analysis from a prospective multicenter community-based study, Diseases of the Esophagus, , doy099, https://doi.org/10.1093/dote/doy099.2 Harrison R, Perry I, Haddadin W, McDonald S, Bryan R, Abrams K, Sampliner R, Talley NJ, Moayyedi P, Jankowski JA. Detection of intestinal metaplasia in Barrett’s esophagus: an observational comparator study suggests the need for a minimum of eight biopsies. Am J Gastroenterol. 2007;102:1154–1161.3 Sharma P. Review article: emerging techniques for screening and surveillance in Barrett’s oesophagus. Aliment Pharmacol Ther 2004; 20: 63–70; discussion 95–6.

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/4236eea0-ffcf-4bd3-9642-1610d1bd907d

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