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New Data Presented at DDW 2019 Demonstrate That WATS3D Provides Clinical Benefit in Detecting Residual/Recurrent Intestinal Metaplasia in Post-Barrett’s Esophagus Ablation Patients

CDx DiagnosticsMay 18, 2019

- Study shows that the addition of WATS3D increased the detection of residual/recurrent intestinal metaplasia by 79% and associated dysplasia by 224% -

SUFFERN, N.Y., May 18, 2019 (GLOBE NEWSWIRE) -- CDx Diagnostics®, innovator of the WATS3D® diagnostic tissue test for the detection and surveillance of Barrett’s esophagus (BE), a known precursor to esophageal adenocarcinoma (EAC), today announced positive results from a clinical study evaluating WATS3D (Wide Area Transepithelial Sampling with 3D Tissue Analysis) in detecting residual/recurrent intestinal metaplasia (RRIM) in patients who have undergone BE ablation. The study shows that the addition of WATS3D to forceps biopsy (FB) resulted in an average increase in the detection of RRIM by 79% and associated dysplasia by 224%. Michael S. Smith, MD, MBA, Chief of Gastroenterology and Hepatology at Mount Sinai West and Mount Sinai St. Luke’s Hospitals in New York City, is presenting the study results today in a poster session (Abstract #Sa1144) at Digestive Disease Week® (DDW®) 2019 in San Diego, California.

“The lack of distinctive endoscopic features, disease focality, and sampling error make it difficult to diagnose RRIM following endoscopic ablation of BE,” said Dr. Smith. “Previous studies have shown that adjunctive use of WATS3D increases detection of BE and associated dysplasia in patients undergoing BE screening or surveillance. The results of the current study demonstrate that WATS3D also is a highly effective adjunct to FB for detecting RRIM post-ablation. The improved ability to detect RRIM should help to advance the management, care and outcomes for patients who have undergone BE ablation.”

“The improved ability to detect RRIM should help to advance the management, care and outcomes for patients who have undergone BE ablation.”-Michael S. Smith, MD, MBA Click to tweet

Patients with BE have an increased risk of developing EAC, one of the fastest growing and most fatal cancers in the United States. It is estimated that more than 16,000 deaths from EAC will occur this year. BE ablation removes the altered esophageal tissue that can give rise to EAC. Despite recent technical advances in endoscopic ablation of BE, a significant percentage of patients have RRIM on pathology, even with a negative endoscopy.

The study being presented today at DDW was designed to evaluate the impact of WATS3D on the detection of RRIM and associated dysplasia in the post-BE ablation setting. A total of 802 patients with a history of BE ablation were included, comprising 913 post-ablation endoscopies performed by 118 endoscopists at 76 sites. The study authors concluded that identifying RRIM, especially when dysplasia is present, directly impacts the management of patients who have undergone BE ablation. They recommend that post BE-ablation tissue sampling should include both FB and WATS3D in order to maximize the detection of residual or recurrent disease.

“The use of endoscopic ablation to non-invasively destroy precancerous cells before they can progress to cancer has provided a major advance in patient care,” said Dr. Mark Rutenberg, Founder and Chief Scientific Officer, CDx Diagnostics. “However, a significant limitation to its reliability is that patients are often left with post-treatment residual or recurrent BE and dysplasia that are not endoscopically visible. The ability of WATS3D to both sharply enhance the initial detection of pre-cancer, and also close this reliability gap in its ablative therapy, are both key to making EAC, one of the most rapidly growing cancers in the US, into a preventable disease.”

Presentation InformationPresentation Category: Esophageal, Gastric & Duodenal DisordersSubcategory: Barrett’s Esophagus: Diagnosis, Management and SurveillanceSa1144: WIDE AREA TRANSEPITHELIAL SAMPLING IMPROVES DETECTION OF INTESTINAL METAPLASIA AND DYSPLASIA FOLLOWING ENDOSCOPIC ABLATION OF BARRETT’S ESOPHAGUS (Society: AGA)

- Type: Poster- Time: Noon–2:00 pm; Date: Sat. May 18th; Room: Halls C-E- Main session: Barrett’s Esophagus: Diagnosis, Management and Surveillance- Author Block: Michael S. Smith1, Vivek Kaul2, Robert Odze

o 1Medicine/Gastroenterology, Mount Sinai West & Mount Sinai St. Luke’s Hospitals, New York, New York, United States; 2Medicine/Gastroenterology, University of Rochester Medical Center, Rochester, New York, United States

To learn more about WATS3D, visit www.wats3d.com.

About WATS3D

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 artificial intelligence 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 cellular changes. 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

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