CDx Diagnostics’ WATS3D Receives “Medically Necessary” Designation from Highmark Health Plans


Highmark Blue Cross Blue Shield, Highmark BCBS Delaware, and Highmark BCBS West Virginia join numerous payors in creating positive medical policy for WATS3D

SUFFERN, NY (November 17, 2021) – WATS3D, a diagnostic platform developed by CDx Diagnostics to empower physicians to detect Barrett’s esophagus (BE) and esophageal dysplasia, has been designated as medically necessary by Highmark Blue Cross Blue Shield plans in Delaware, Pennsylvania, and West Virginia. Clinically proven to significantly increase the detection rate of BE, pre-cancer, and cancerous cells in the esophagus compared to the traditional screening methods, WATS3D is now a covered benefit for more than 3.6 million Highmark members.

WATS3D, which is intended as an adjunct to standard four-quadrant biopsies for screening, diagnosis, or surveillance of cancerous or precancerous esophageal lesions, may be considered medically necessary for the surveillance of both Barrett’s esophagus and chronic gastroesophageal reflux disease (GERD).

“Highmark Blue Cross Blue Shield’s positive medical policy for WATS3D demonstrates the momentum CDx Diagnostics has built, bringing access to WATS3D to a total of 10 Million members.” said Bill Huffnagle, CEO of CDx Diagnostics. “By empowering healthcare professionals to stop cancer before it starts, CDx helps physicians and payors improve patient outcomes through our potentially life-saving technology.”

WATS3D technology helps clinicians to overcome the limitations associated with traditional upper endoscopy screening and surveillance methods, by combining a specially designed brush, unique 3D imaging powered by artificial intelligence, and a team of trained GI pathologists. In large multicenter clinical studies, WATS3D has been found to significantly increase the detection rate of BE and esophageal dysplasia, both treatable precursors to esophageal cancer, one of the fastest growing and most fatal cancers in the United States.

WATS3D testing meets the five pillars of evidence-based medicine typically required by insurance payors: analytic validity, clinical validity, clinical utility, cost-effectiveness, and recommendations by major medical societies. The American Society for Gastrointestinal Endoscopy (ASGE), the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), and the American Foregut Society (AFS) each currently include WATS3D testing in their recommendations.

Since 2019, the ASGE has included WATS3D in its Standards of Practice Committee’s guideline for the screening and surveillance of BE. In 2020, the technology was deemed a safe and effective adjunct to forceps biopsies in the evaluation of BE, low-grade dysplasia, and high-grade dysplasia by SAGES Technology and Value Assessment Committee (TAVAC).


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