SAGES TAVAC Analysis Indicates WATS3D is a Safe and Effective Diagnostic Technique for Barrett's Esophagus

SUFFERN, N.Y., June 16, 2020 (GLOBE NEWSWIRE) -- WATS^3D, an AI-powered diagnostic platform used to identify precancerous cells in the esophagus, has been deemed as a safe and effective adjunctive to forceps biopsies in the evaluation of Barrett's esophagus (BE), low-grade dysplasia, and high-grade dysplasia. The review of the efficacy, value and safety of the diagnostic platform was conducted by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and its Technology and Value Assessment Committee (TAVAC) and published in the SAGES' peer review journal Surgical Endoscopy (link: doi.org/10.1007/s00464-020-07503-w).

The TAVAC review process included a systematic analysis of previously published clinical studies and data on PubMed/Medline, along with bibliographies of key references for relevant information not included in the PubMed database. Among the data reviewed by TAVAC were the results of studies that indicated that WATS^3D has been shown to significantly increase the diagnostic yield of BE, low-grade dysplasia, and high-grade dysplasia when compared to forceps biopsy alone.

According to Shawn Tsuda, MD, FACS, board-certified surgeon and Chair of the SAGES TAVAC, the Committee's review found that WATS^3D has very high inter-observer agreement for pathological diagnosis and produced consistent outcomes in the increased detection of pre-malignant diseases of the esophagus. "The current method for tissue sampling via the Seattle protocol for the detection of Barrett's esophagus has its limitations," says Tsuda. "A significant increase in sensitivity provided by WATS^3D has the potential to increase the value of routine surveillance for Barrett's, as well as low-grade and high-grade dysplasia. For the surgeon and endoscopist, this can guide intervention with greater confidence and potentially improve outcomes in patients with pre-malignant esophageal disease."

"Through stringent review and analysis, like that offered by SAGES TAVAC, the life-saving potential of WATS^3D continues to be recommended," says CDx Diagnostics CEO William Huffnagle. "We're encouraged that WATS^3D is being incorporated into more routine testing practices where a patient's health concerns can be identified and treated before they develop into cancer."

The SAGES TAVAC analysis follows a series of recently published external reviews of the WATS^3D technology. In 2019, the American Society for Gastrointestinal Endoscopy (ASGE) included WATS^3D in its Standards of Practice Committee's guideline for the screening and surveillance of BE. In addition, the technology was included in a white paper from the American Foregut Society (AFS) which indicated there is sufficient data to support the routine use of WATS^3D in the ongoing evaluation of BE.

About WATS^3D
WATS^3D addresses the major inadequacies 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 specimen for computer-assisted 3D laboratory analysis prior to diagnosis by any WATS^3D certified pathologist. In large multicenter clinical trials, WATS^3D has been found to significantly increase the detection rate of both Barrett's esophagus and esophageal dysplasia. The high sensitivity and inter-observer agreement of WATS^3D is due to the larger tissue area sampled, and the proprietary 3-Dimensional computer imaging system that is based on an artificial intelligence algorithm developed as part of the U.S. Strategic Defense Initiative missile defense program. To learn more about WATS^3D, visit www.wats3d.com.

About CDx Diagnostics
CDx Diagnostics' mission of Empowering Physicians with Innovative Technology to Prevent Esophageal Cancer, One Patient at a Time 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. Routine clinical use of CDx testing has already detected thousands of precancers that would otherwise have been missed in time for effective endoscopic treatment.  Additionally, CDx Diagnostics is looking to apply its next-generation diagnostic platform to prevent cancers of the bile duct, stomach, and IBD affected colon. CDx Diagnostics is a Galen Partners portfolio company. To learn more about CDx Diagnostics, visit www.cdxdiagnostics.com.

About SAGES
Founded in 1980, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) represents a worldwide community of surgeons that can bring minimal access surgery, endoscopy and emerging techniques to patients in every country. The mission of the Society is to improve quality patient care through education, research, innovation and leadership, principally in gastrointestinal and endoscopic surgery. More information is available online at www.sages.org.

Contact: Donnie Turlington
Phone: 336-991-7711
Email: dturlington@bouvierkelly.com