SOURCE: CDx Diagnostics

CDx Diagnostics

May 18, 2015 08:00 ET

Multi-Center Study Shows WATS3D Biopsy Increases Detection of Esophageal Pre-Cancer by 60% Following Endoscopic Ablation of Barrett's Esophagus

New Data Based on Largest Cumulative Post-Ablation Data Set to Date

SUFFERN, NY--(Marketwired - May 18, 2015) -  CDx Diagnostics announced today new clinical data from a multi-center study demonstrating the utility of the WATS3D biopsy for post-ablation surveillance of Barrett's esophagus and esophageal dysplasia. The results, from the largest data sample of its kind presented to date, found that adding WATS3D to forceps biopsy increased the detection of residual or recurrent Barrett's and dysplasia by approximately 60%. These results were highlighted during an oral presentation, "Transepithelial Brush Biopsy With Computer-Assisted Tissue Analysis Increases Detection Of Residual Or Recurrent Intestinal Metaplasia And Dysplasia Following Endoscopic Ablation Of Barrett's Esophagus," held during Digestive Disease Week 2015 (DDW), taking place from May 16-19, 2015 in Washington D.C.

The WATS3D biopsy collects a wide area, disaggregated tissue specimen of the entire thickness of the suspect epithelium. This unique tissue specimen is then subjected to specialized, computer-assisted 3-dimensional analysis to pinpoint potentially abnormal cells for presentation to a pathologist. In clinical trials, adjunctive use of WATS3D significantly increased the detection rate of both Barrett's esophagus and esophageal dysplasia in screening1-2 and surveillance3 populations. 

"Ablation therapy for Barrett's esophagus is the most powerful tool available to help us protect patients from esophageal adenocarcinoma, one of the fastest growing and most deadly forms of cancer in the United States," said Michael S. Smith, MD, MBA, Medical Director of the Esophageal Program at the Temple University School of Medicine. "Following ablation therapy, patients require ongoing endoscopic surveillance to ensure that all pre-cancerous cells were destroyed and that they do not return. Currently we follow these patients using multiple small random forceps biopsies which can test only a small fraction of the esophageal lining. This study is important because it deepens our understanding of the key role that WATS3D can play in addressing the sampling error generated by using a technique that leaves such a large amount of unsampled tissue, where untreated precancerous disease could be hidden."

The study included 208 procedures and 110 patients. Pre-ablation histology included high grade dysplasia or intramucosal adenocarcinoma (55.5%), low grade dysplasia (20.9%) and non-dysplastic Barrett's esophagus (23.6%). Forceps biopsy identified post-ablation residual or recurrent intestinal metaplasia in 39 cases (18.8%), and dysplasia or neoplasia in 7 cases (3.4%). Adjunctive use of WATS3D identified another 24 cases of Barrett's esophagus and four cases of dysplasia missed by forceps biopsy. Therefore, the incremental yield of adding WATS3D to forceps biopsy for these post-ablation patients was 61.5% for intestinal metaplasia and 57.1% for dysplasia and neoplasia. No complications associated with WATS3D were reported.

"These data demonstrate that in the post-ablation setting, adjunctive use of WATS3D with forceps biopsy increases detection of residual or recurrent esophageal pre-cancer in the absence of endoscopically visible disease," said lead author Natalya Iorio, MD, of Temple University Hospital. "Further studies will help us optimize the WATS3D sampling technique to maximize detection of metaplasia, dysplasia and neoplasia, as well as determine which patients will benefit most from its use."

Vivek Kaul, MD, FACG, FASGE, Chief of Gastroenterology at the University of Rochester Medical Center, added: "Patients with Barrett's esophagus should be aware that major strides have been made in the management and treatment of the disease, primarily through endoscopic ablation techniques. With the right care plan, progression to esophageal adenocarcinoma is now preventable. However, effective, frequent surveillance following an ablation procedure is also critically important. With the WATS3D brush biopsy sampling, both gastroenterologists and patients can feel an added measure of confidence in the surveillance results, over and above standard forceps biopsy results alone."

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.

About Digestive Disease Week®
Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 16-19, 2015, at the Walter E. Washington Convention Center, Washington, DC. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.

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. Gross et al. Esophageal Brush Biopsy With Computer-Assisted Tissue Analysis Increases Detection of Barrett's Esophagus and Dysplasia in a Multi-Site Community-Based Setting. Presented at Digestive Disease Week; May 2-6, 2014. Chicago. Abstract 371.
3. 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.

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