CDx Diagnostics, developer of the WATS3D diagnostic platform for the screening and surveillance of Barrett’s esophagus (BE), a known precursor to esophageal cancer (EC), today announced that the American Society for Gastrointestinal Endoscopy (ASGE) has included WATS3D in its Standards of Practice Committee’s guideline for the screening and surveillance of BE. A copy of the Standards of Practice Committee’s guideline can be found here.
“It is our hope that broader use of WATS3D can potentially transform EC into a preventable disease. I would like to thank the physicians who have participated in our clinical studies for their guidance and dedication as well as the CDx team led by Dr. Mark Rutenberg for enabling us to reach this pivotal milestone today,” said William Huffnagle, CEO of CDx Diagnostics.
Since esophageal dysplasia is both highly focal and typically invisible, the effectiveness of upper endoscopy is widely recognized to be limited by the high rate of false-negative sampling error associated with standard 4-quadrant random biopsy. WATS3D, or Wide Area Transepithelial Sampling with 3D Tissue Analysis, addresses this limitation by using an abrasive sampling brush to create a wide area tissue sample that unlike standard cytology instruments also captures the full thickness of the epithelium, penetrating into the submucosa. This uniquely comprehensive tissue sample had not been attempted before since it is up to 50X thicker than the depth of field of a standard laboratory microscope. CDx Diagnostics invested over $80M in the development of a three-dimensional computer image analysis system that creates a 3D Micro-Biopsy view of the specimen for review by an artificial intelligence-based neural network system that highlights to any WATS3D certified pathologist potential abnormality found in this complex tissue specimen.
“This important change to the ASGE practice guideline for BE was based on a systematic review of the available literature and reflects consistent findings in multiple studies with prospectively collected data from over 15,000 patients who had WATS3D in addition to forceps biopsies,” said Michael S. Smith, MD, MBA, Chief of Gastroenterology and Hepatology at Mount Sinai West and Mount Sinai St. Luke’s Hospitals, the author of the largest prospective community based study of WATS3D.
“Early detection and treatment of dysplasia has radically reduced deaths from cervical and colon cancers, but has had limited utility in reducing EC deaths partly due to the limitations of screening and surveillance protocols that rely on a tiny forceps biopsy to detect a small area of invisible precancerous change,” said Mark Rutenberg, PhD, MSEE, Founder and Chief Scientific Officer of CDx. “Adjunctive use of WATS3D in more than 250,000 patients, over 10 years, in both academic and community settings, has shown that it effectively addresses this limitation. Moreover, large published prospective trials from real world-community practice settings have demonstrated increased detection of dysplasia and Barrett’s by more than 200% and 100% respectively.”
“The quality of evidence supporting routine adjunctive use of WATS3D is at least as high as that which supports screening and surveillance endoscopy itself,” said Charles J. Lightdale, MD, of the Columbia University Medical Center and one of the authors of a 16 site academic center clinical trial of WATS3D which found that it increased the detection of the smallest, most elusive, and most dangerous form of dysplasia (HGD) by over 400%, even when compared to the meticulous endoscopy and random biopsy performed in specialty BE centers. Dr. Lightdale continued: “This ASGE recommendation recognizes that the incorporation of WATS3D into the routine clinical practice of both community and academic gastroenterology will provide an important benefit to patients by helping to ensure that their chronic heartburn and/or BE will not be allowed to develop into a devastating disease.”
Dr. Michael Smith served as Co-Principal Investigator on the National Clinical Trial and has received compensation as a consultant to CDx Diagnostics.
Dr. Charles Lightdale participated as one of the investigators in a multicenter, academic clinical trial of WATS3D and has received compensation as a consultant to CDx Diagnostics.
Esophageal adenocarcinoma (EA) is one of the fastest growing and most fatal cancers in the United States, with an incidence that has quadrupled in men over the past two decades. It is estimated that approximately 17,650 new cases of EA will be diagnosed this year, resulting in approximately 16,080 deaths. EA can be prevented if it is detected and treated while still a harmless precancerous change which is the motivation for the millions of upper endoscopies performed each year on patients which chronic GERD and Barrett’s esophagus. A key factor limiting the effectiveness of this strategy is the fact that esophageal precancer is both highly focal and invisible and that random biopsy sampling tests less than 5% of the known or suspected BE segment. The impact of these limitations is significant, as a previously reported study showed that 25% of cancer patients diagnosed with EC had undergone FB in the previous two years.
In contrast, WATS3D samples a much greater tissue area, enabling detection of dysplastic and abnormal cells that are located between FB samples. The wider sampling area with WATS3D sharply increases the routine detection of BE and ED compared with FB.
Critically, the computer synthesized WATS3D image presents an in vivo, en face view of the gland to the pathologist — allowing for a definitive diagnosis of dysplasia in cases that would otherwise be reported as “indefinite.”
Additionally, the WATS3D computer-assisted technology yields sharply higher inter-observer agreement among pathologists compared with FB. This is because the WATS3D neural network highlights the most suspicious areas on this computer synthesized image areas for consistent pathologist review.
To learn more about WATS3D, and to access our library of photos and videos, visit https://www.cdxdiagnostics.com/media-resources/.