New results published in Gastrointestinal Endoscopy
SUFFERN, NY--(Marketwired - Aug 8, 2017) - CDx Diagnostics, developer of the WATS3D biopsy, or Wide Area Transepithelial Sampling with 3D Tissue Analysis for the detection and surveillance of Barrett's esophagus today announced the publication of new, pivotal, multicenter, crossover data in the latest issue of Gastrointestinal Endoscopy. The study found that WATS3D increased the detection of High-Grade Dysplasia and Esophageal Adenocarcinoma (HGD/EAC) by more than 400% compared to the standard Seattle protocol random forceps biopsy, even when those random biopsies are carefully performed in academic centers by some of the world's most experienced endoscopists.
"At the current time, endoscopists rely solely on taking small random forceps biopsies at 1-2 cm intervals, leaving more than 96% of the endoscopically suspect area completely untested. The publication of this study underscores the severe limitations of our current random biopsy protocol as well as the value of taking a few extra minutes to add the WATS3D procedure as a standard of care," said lead author Prashanth R. Vennalaganti, MD, of Kansas City VA Medical Center and University of Kansas School of Medicine, Kansas City, Missouri.
The multi-center, prospective, randomized, tandem study was conducted in 16 major academic US GI centers. In the study, WATS3D detected 29 cases of HGD/EAC while the Seattle random forceps biopsy detected only seven such cases among 160 high-risk patients undergoing Barrett's esophagus surveillance.
"These results are quite compelling," said Robert D. Odze, MD, Director of the GI Pathology Division at the Brigham and Women's Hospital and Professor of Pathology at the Harvard Medical School who was not a participant in the study. He continued, "WATS3D not only addresses the sampling error inherent in relying on random forceps biopsies, its three-dimensional computer assisted analysis of the tissue sample provides the GI pathologist with diagnostic information that is not typically available using standard tissue based histopathology. We look forward to implementing this advance in gastroenterology and GI pathology to enhance routine care for our own practitioners."
"I can think of very few high impact studies in the field of Barrett's esophagus that should change how gastroenterologists, both community-based and academic, care for their patients, and this study is one of them," said Michael S. Smith, MD, MBA, incoming Chief of Gastroenterology and Hepatology at Mount Sinai West and Mount Sinai St. Luke's Hospitals in New York, who participated in the study. "These robust data demonstrate we have a tool that markedly improves our ability to detect dysplasia and cancer within Barrett's well beyond the error-prone Seattle protocol."
"Participation in this multicenter study, and further experience using WATS3D in my large Barrett's practice, has resulted in its incorporation into my routine clinical care," said Dr. Charles Lightdale, MD of the Columbia University Medical Center, New York. He continued, "Routine clinical use of WATS3D continues to demonstrate increased diagnostic yield in my patients, including in post-ablation surveillance. I see no reason why every academic and community gastroenterologist should not be using this rapidly performed, easily implemented procedure today to improve the diagnosis of Barrett's esophagus and dysplasia, so patients can be directed to appropriate endoscopic surveillance or therapy to prevent esophageal cancer."
"The current standard of care forces gastroenterologists to rely on chance, hoping that one of their small random forceps biopsies will happen to land on a highly focal area of 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 US is to more reliably identify those GERD and Barrett's patients with these still harmless but precancerous changes so that we can treat them in time to prevent their progression to adenocarcinoma. These results clearly demonstrate that WATS3D can very effectively help to fill that critical gap in current routine GI care."
CDx Diagnostics' WATS3D biopsy addresses the major sampling error 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 tissue sample for computer-assisted 3D laboratory analysis. 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 interobserver agreement of WATS3D is due to the larger 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 CDx Diagnostics
CDx Diagnostics' mission is to provide clinicians with easily implemented, cost effective, tools to preempt cancer through enhanced detection 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 for precancerous change 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, and stomach, is currently in progress.