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 (Oral 345), “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.
Michael S. Smith, MD, MBA, Medical Director of the Esophageal Program at the Temple University School of Medicine said:
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, 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 important 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 (3.37%). 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 reporte“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 the 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.”