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Press release content from Globe Newswire. The AP news staff was not involved in its creation.

CDx Diagnostics Appoints Industry Leader Bill Huffnagle as Chief Executive Officer

May 7, 2019

- Leadership transition underscores significant commercial opportunity for WATS3D -

- Wide-scale adoption of WATS3D is helping make esophageal adenocarcinoma, one of the most rapidly growing cancers in the US, a preventable disease -

SUFFERN, N.Y., May 07, 2019 (GLOBE NEWSWIRE) -- CDx Diagnostics®, innovator of the WATS3D® diagnostic tissue test for the detection and surveillance of Barrett’s esophagus (BE), a known precursor to esophageal adenocarcinoma (EA), today announced the appointment of Bill Huffnagle as Chief Executive Officer (CEO). Former CEO and Founder Mark Rutenberg will transition to the newly-created role of Chief Scientific Officer (CSO) and will focus on WATS3D-related clinical studies and expanding the application of the company’s transepithelial tissue sampling and Artificial Intelligence-based computer-assisted analysis platform.

Mr. Huffnagle brings significant medical device experience to CDx Diagnostics, having most recently served as president of Stryker’s Joint Replacement Division where he managed the global hip and knee business. During his tenure at Stryker, Mr. Huffnagle spearheaded the integration of Mako Surgical, the acquisition propelling Stryker to lead the world in orthopedic robotic-assisted surgery.

“We believe, based on very strong published WATS3D data, that an increasing numbers of endoscopists are no longer willing to rely on random biopsy alone to protect their patients against one of the most rapidly growing cancer in the US. We are continuing to witness WATS3D becoming the standard of clinical care for the over 5 million upper endoscopies performed annually on patients with chronic heartburn and Barrett’s esophagus. CDx is poised for significant growth and I cannot think of a better person than Bill Huffnagle to manage and lead CDx at this stage,” said Dr. Mark Rutenberg, CSO. “I look forward to assisting Bill in leading the company’s clinical trials and scientific programs for further application of the WATS3D technology platform.”

“This is a pivotal time for CDx Diagnostics as we see WATS3D on a path to becoming standard practice in esophageal screening and surveillance,” said Thomas Bologna, chairman of CDx Diagnostics’ board of directors. “Bill is ideally suited to lead the company through its next phase of commercialization and value creation. His track record of delivering strong returns aligns perfectly with our needs and I am confident he will help realize the full potential of the company’s scientific assets.”

“I am thrilled to join CDx Diagnostics at this important juncture and look forward to working with the experienced team to deliver on WATS3D’s promise of enabling physicians to bring better patient care by detecting precancerous cells before they can progress to cancer,” said Bill Huffnagle, CEO.

To learn more about WATS3D, visit www.wats3d.com.

About WATS3D WATS3D 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 a pathologist. 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 inter-observer agreement of WATS3D 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 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 of precancerous cellular changes. 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 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, stomach, and colon is currently in progress.

Contact: Chantal Beaudry or John Guerriero for CDx Diagnostics cbeaudry@lazarpartners.comjguerriero@lazarpartners.com 212-867-1762

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/323f44c4-8e53-4474-b641-29829aff55dc