PIONEER IN THE USE OF AI IN THE DETECTION OF DYSPLASTIC CELLS IS PAVING THE FUTURE OF DIAGNOSTICS
SUFFERN, N.Y., February 8, 2024 – CDx Diagnostics, Inc. today announced that it has received its 400,000th WATS3D specimen. WATS3D, 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 WATS3D 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, WATS3D 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 WATS3D increases diagnostic yield regardless of Barrett’s segment length.
“As an author of many of the WATS3D-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 WATS3D 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 WATS3D studies or this press release.
Dr. John Hong, CEO of United Surgery Centers in Southern California, whose case marked the 400,000th WATS3D procedure adds: “Incorporating WATS3D 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 WATS3D 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 WATS3D 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, WATS3D is contributing to the prevention of esophageal cancer and making a difference in the lives of patients.”
About CDx Diagnostics
CDx Diagnostics’ mission is to provide clinicians with easily implemented, cost effective tools to preempt cancer through enhanced detection of precancerous change. 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, stomach, and surveillance for dysplasia of the colon in patients with IBD is currently in progress.
About WATS3D
CDx Diagnostics’ 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 tissue sample for computer-assisted 3D laboratory analysis by expert pathologists. 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-Dimensionial computer imaging system that is based on an algorithm developed as part of the U.S. Strategic Defense Initiative missile defense program. To learn more about WATS3D, visit www.wats3d.com.
