CDx Diagnostics’ ​​WATS3D Participates in Highmark, Inc. Health Plans in Delaware, Pennsylvania, and West Virginia

Highmark, Inc. joins numerous payors in creating positive medical policy for WATS^3D and opening participation in their networks

SUFFERN, N.Y.–(BUSINESS WIRE)–WATS^3D, an AI-powered diagnostic platform developed by CDx Diagnostics to empower physicians to reliably detect Barrett’s esophagus (BE) and esophageal dysplasia to help prevent esophageal cancer, was designated as medically necessary by Highmark, Inc. health plans in Delaware, Pennsylvania, and West Virginia in Q4 2021. CDx Diagnostics is pleased to share, that effective immediately, WATS^3D is now considered an in-network procedure as CDx Diagnostics participates in the Commercial and Medicare networks of these Highmark, Inc. plans.

Clinically proven to significantly increase the detection rate of BE, pre-cancer, and cancerous cells in the esophagus compared to the traditional screening methods, WATS^3D is now a covered benefit for more than 3.6 million Highmark members. The computer-assisted procedure, 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).

“Using artificial intelligence to reliably detect precancerous cells is truly remarkable science. Empowering physicians to preempt esophageal cancer and improve patient lives is what drives us. We are therefore delighted to announce Highmark’s decision to issue a positive medical policy for WATS^3D because it means a total of 36 million contracted health plan members now have access to our life-saving technology,” said Bill Huffnagle, CEO of CDx Diagnostics.

WATS^3D technology helps clinicians to overcome the limitations associated with traditional upper endoscopy screening and surveillance methods, by combining a specially designed tissue acquisition instrument, unique 3D imaging with artificial intelligence powered analysis, and a team of trained expert GI pathologists. In large multicenter clinical studies, WATS^3D 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.

WATS^3D 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 WATS^3D testing in their recommendations.

Since 2019, the ASGE has included WATS^3D 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 and its Technology and Value Assessment Committee (TAVAC).

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. CDx tests 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 has already detected thousands of cancers that would otherwise have been missed in time for effective endoscopic treatment and application of the CDx Diagnostics platform to prevent cancers of the bile duct, stomach, and IBD affected colon is currently in progress. CDx Diagnostics is a Galen Partners portfolio company. To learn more, visit http://www.cdxdiagnostics.com.

Contacts

Logan Garrett

423.519.9979

lgarrett@bouvierkelly.com