400,000 WATS(3D) Procedures Marks Significant Milestone In Advancing Patient Care & Saving Lives

PIONEER IN THE USE OF AI IN THE DETECTION OF DYSPLASTIC CELLS IS PAVING THE FUTURE OF DIAGNOSTICS

SUFFERN, N.Y., Feb. 8, 2024 /PRNewswire/ -- CDx Diagnostics, Inc. today announced that it has received its 400,000^th WATS^3D specimen. WATS^3D, the company's proprietary diagnostic platform leverages AI enabled tissue analysis and 3D imaging to identify precancerous cells in the esophagus. This remarkable achievement speaks to the company's commitment to changing the landscape of cancer prevention through innovative technological solutions.

Esophageal cancer, a deadly disease with a mere 20% five-year survival rate, has seen a staggering 767% increase in incidence in the US over the past 40 years. During that time, the Seattle protocol, relying on random four-quadrant forceps biopsies, served as the standard technique for detection of Barrett's esophagus (BE) and dysplasia. This approach has proven inadequate, with high sampling error rates that contribute to approximately 50% miss rate of BE cases during patients' screening upper endoscopies, underscoring the need for improved diagnostic approaches. Barrett's esophagus is the sole known precursor to this cancer.

The WATS^3D 3-in-1 solution is well documented to find Barrett's esophagus and dysplasia more reliably than the current standard alone. When added as an adjunct to random forceps biopsy, WATS^3D has been shown to be effective at increasing the detection of BE and dysplasia by 153% and 242%, respectively, for patients with no prior diagnosis of Barrett's and those in surveillance. Additionally, studies have demonstrated that WATS^3D increases diagnostic yield regardless of Barrett's segment length.

"As an author of many of the WATS^3D-related publications in the peer-reviewed literature, which represent over 20,000 procedures, it is clear that this technology provides an opportunity to identify more cancer and pre-cancer compared to the current practice of using only forceps biopsies. The data clearly show a benefit of adjunctive use of the WATS^3D device and AI system throughout the Barrett's esophagus life cycle, from initial diagnosis to surveillance before and after endoscopic eradication therapy," said Dr. Michael S. Smith, Chief of Gastroenterology & Hepatology, Mount Sinai West & Mount Sinai Morningside Hospitals. Dr. Smith is a paid consultant with CDx Diagnostics. He has not received compensation for his work on the WATS^3D studies or this press release.

Dr. John Hong, CEO of United Surgery Centers in Southern California, whose case marked the 400,000^th WATS^3D procedure adds: "Incorporating WATS^3D into our Gastroenterology practice has allowed our physicians to improve detection of Barrett's Esophagus and dysplasia in a clinically significant way which has greatly impacted the prevention, morbidity and mortality of esophageal cancer in our patient population."

The growing body of clinical evidence has led to the inclusion of WATS^3D in the American Society for Gastrointestinal Endoscopy (ASGE)'s Standard of Practice Guidelines for the screening and surveillance of Barrett's and dysplasia as well as the American Gastroenterological Association (AGA)'s Clinical Practice Update and recommendations by the American Foregut Society (AFS) and Society of American Gastrointestinal and Endoscopic Surgeons (SAGES).

"This accomplishment emphasizes the unwavering dedication and hard work of the entire CDx team. It signifies our deep commitment to advancing our mission of empowering physicians with cutting-edge technology to proactively address cancer. Additionally, it highlights the widespread trust and acceptance of WATS^3D technology and services within the US GI medical community," expressed Duane Dorn, Chief Operating Officer at CDx Diagnostics. "It's becoming clear that through our partnership with physicians, delivering reliable diagnostic information, WATS^3D is contributing to the prevention of esophageal cancer and making a difference in the lives of patients."

About CDx Diagnostics
CDx Diagnostics' mission of Empowering Physicians with Innovative Technology to Prevent Esophageal Cancer, One Patient at a Time is accomplished through a proprietary diagnostic platform. This combination of technology synthesizes computer imaging, artificial intelligence, molecular biology and three-dimensional cytopathology to detect precancerous changes 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. Routine clinical use of CDx testing has detected thousands of cancers and precancerous conditions that otherwise would have been missed.

Contact:
Logan Garrett
423.519.9979
lgarrett@bouvierkelly.com

SOURCE CDx Diagnostics