Results From a Pivotal Prospective Randomized Crossover Study Conducted at 14 Major Academic Gastroenterology Centers to Be Presented at Digestive Disease Week
SUFFERN, NY--(Marketwired - May 21, 2016) - CDx Diagnostics today announced final data from a multicenter, prospective, randomized, crossover study demonstrating a fourfold increase in the detection of High-Grade Dysplasia and Esophageal Adenocarcinoma (HGD/EAC) using wide-area transepithelial sampling with three dimensional tissue analysis (WATS3D). In this study, WATS3D was compared with the Seattle random forceps biopsy protocol used for the endoscopic surveillance of patients with Barrett's esophagus. The study, "Increased Detection of Barrett's Esophagus-Associated Neoplasia Using Wide Area Transepithelial Sampling in Conjunction with 4-Quadrant Forceps Biopsies: Final Results from a Multi-Center, Prospective, Randomized Trial," is being presented during Digestive Disease Week (DDW) 2016, taking place from May 21-24, 2016 in San Diego, California.
Detecting esophageal dysplasia (precancer) can prevent the development of esophageal adenocarcinoma, the most rapidly growing cancer in the U.S. and one of the most fatal. In an effort to find esophageal dysplasia before it can progress into cancer, more than five million upper endoscopies are performed each year by gastroenterologists on their patients with chronic heartburn and Barrett's esophagus.
Until the advent of WATS3D, these doctors had to rely on taking small forceps biopsies (FB) every 1-2 cm during upper GI endoscopy, a method known as the Seattle protocol, which leaves the vast majority of the esophagus untested, and is completely random.
In this multicenter, prospective study conducted at 14 major academic GI centers, 160 high-risk patients undergoing Barrett's esophagus surveillance received both Seattle protocol random FB and WATS3D. WATS3D found 4.1x more HGD/EAC than the Seattle protocol random biopsies; detecting 29 cases of HGD/EAC while the Seattle random FB detected only 7 such cases.
"The study's data demonstrate that the use of WATS3D sharply increases the detection rates of the most serious forms of esophageal precancer compared to even meticulously performed random biopsy," said lead author, Prashanth R. Vennalaganti, MD, of Kansas City VA Medical Center, Kansas City, Missouri.
WATS3D utilizes a specially designed brush biopsy instrument to rapidly collect a wide-area disaggregated tissue sample of the entire thickness of the suspect epithelium. This uniquely thick, highly complex tissue specimen is then subjected to specialized, computer-assisted, three-dimensional image analysis to pinpoint potentially abnormal cells for presentation to a pathologist who then utilizes standard pathologic criteria to make the diagnosis.
In this study, Seattle Protocol FB detected 7 cases of HGD/EAC, 6 of which were also detected by WATS3D with the remaining case reported by WATS3D as Indefinite for Dysplasia/Low-grade Dysplasia (IND/LGD). WATS3D found an additional 23 cases of HGD/EAC not detected on FB (12 were reported by FB as IND/LGD, while 11 were reported by FB as Non-Dysplastic Barrett's Esophagus (NDBE) only). All cases of WATS3D discovered HGD/EAC not found on FB were then subjected to a second blinded independent review by two central Cleveland Clinic pathologists, requiring unanimous confirmation of the WATS3D finding using standard pathologic criteria.
"Gastroenterologists doing an upper endoscopy no longer have to rely on sheer luck, hoping that a small random forceps biopsy will happen to land on the invisible precancer which their patient might have," said Mark Rutenberg, Chairman and CEO of CDx Diagnostics, the developer of the WATS3D diagnostic system. "Due to the recent introduction of non-invasive, endoscopic ablation, esophageal precancer can now be easily treated. The only remaining obstacle to the prevention of the most rapidly growing cancer in the US is identifying those patients with precancer. The powerful results of this carefully performed multicenter study demonstrate that WATS3D can help to fill that critical gap in current routine GI care."
To learn more about the WATS3D biopsy, please visit the CDx Diagnostics booth #243 throughout DDW or visit www.WATS3D.com.
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.
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 S 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.