Barretts esophagus with high grade dysplasia

SUFFERN, N.Y., March 6, 2024 /PRNewswire/ -- CDx Diagnostics, Inc., developer of the WATS3D AI platform for the detection and surveillance of Barrett's esophagus (BE) and dysplasia, today announced the publication of "WATS3D: An Interobserver Study of Barrett's Esophagus–Associated Dysplasia Among Gastrointestinal Pathologists" in Clinical and Translational Gastroenterology. The study provides new insights into the use of CDx's AI-powered diagnostic technology to consistently identify precancerous cells in patients with BE, thereby helping prevent the development of esophageal cancer. Continue Reading This was a collaborative study among gastrointestinal pathologists who have an interest and expertise in Barrett's esophagus. The lead author in this study was Dr. Deepa Patil of Brigham and Women's Hospital, Boston, MA. Additional contributors include: John R. Goldblum, MD (Cleveland Clinic), Gregory Lauwers, MD (Moffitt Cancer Center), Jason T. Lewis, MD (Mayo Clinic), Marie Robert, MD (Yale University School of Medicine), Mendel Singer, PhD, MPH, (Case Western Reserve University School of Medicine), and senior author, Robert D. Odze, MD (Tufts Medical Center). WATS3D Study Demonstrates Exceptional Consensus Among Pathologists. Post this The study set out to address the challenges in grading BE and dysplasia where the histopathological diagnosis of Barrett's esophagus-associated dysplasia has poor inter-observer agreement even among experienced gastrointestinal pathologists.1-3 Published estimates for the inter-observer agreement ("kappa values") for diagnosing dysplasia on forceps biopsy in Barrett's esophagus have varied between 0.15 and 0.69.1,4 Within this investigation, five GI pathologists were trained in-person and virtually on specimens from CDx's proprietary diagnostic platform, WATS3D, which leverages AI-enabled tissue analysis and 3D-imaging to reliably identify precancerous cells in the esophagus. The pathologists were then asked to evaluate digital images from 60 WATS3D cases with BE. "This study tackles a crucial clinical hurdle in gastroenterology," remarked Dr. Deepa Patil, MD, lead author. "The significant variability among pathologists assessing Barrett's esophagus poses challenges for accurate diagnosis and treatment decisions, complicating patient care." The overall mean kappa value in this study for all diagnoses for the five observers was calculated at 0.93, demonstrating remarkable consistency in interpreting both cell block and smear specimens (kappa=0.93 and 0.97, respectively). Kappa values of above 0.80 indicate nearly perfect agreement (Landis and Koch scale).5 The data represents significant improvement compared to standard histopathology in the diagnosis of BE and dysplasia where the kappa value is only considered to be "fair agreement" - 0.30. In addition, agreement was perfect (100%) regarding detection of neoplasia (either LGD, HGD, or EAC). "Our findings show a high level of accuracy and reproducibility among GI pathologists who have had no prior experience with the WATS3D platform," stated Dr. Robert Odze. "These outcomes are a testament to the effectiveness of CDx Diagnostics' approach to diagnosis. The results define a path to saving more patient lives by significantly improving diagnostic practices and delivering consistent dysplasia detection rates to more clinicians. Taken together with the fact that CDx recently processed and diagnosed its 400,000th WATS3D specimen, the study underscores the reliability and scalability of the technology." said Duane Dorn, Chief Operating Officer at CDx Diagnostics. Visit WATS3D.com to learn more. References 1. Montgomery E, Bronner MP, Goldblum JR et al. Reproducibility of the diagnosis of dysplasia in Barrett esophagus: a reaffirmation. Hum Pathol 2001;32:368-78. 2. Reid BJ, Haggitt RC, Rubin CE et al. Observer variation in the diagnosis of dysplasia in Barrett's esophagus . Hum Pathol 1988 ; 19 : 166-78. 3. Kerkhof M, van Dekken H, Steyerberg EW et al. Grading of dysplasia in Barrett's oesophagus: substantial interobserver variation between general and gastrointestinal pathologists. Histopathology 2007 ; 50 : 920 - 7. 4. Pech O, Vieth M, Schmitz D et al. Conclusions from the histological diagnosis of low-grade intraepithelial neoplasia in Barrett's oesophagus. Scand J Gastroenterol 2007;42:682-8. 5. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977; 33:159-74. 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

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 400,000th 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. Continue Reading 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. CDx Diagnostics, Inc. today announced that it has received its 400,000th WATS3D specimen. Post this 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 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

SUFFERN, N.Y., Aug. 2, 2023 /PRNewswire/ -- CDx Diagnostics, Inc., developer of the WATS3D AI Platform for the detection and surveillance of Barrett's esophagus (BE) and dysplasia, reported positive data in a recently published study, Benefit of Adjunctive Wide Area Transepithelial Sampling with 3- Dimensional Computer-Assisted Analysis Plus Forceps Biopsy Based on Barrett's Esophagus Segment Length, in the American Society for Gastrointestinal Endoscopy (ASGE) journal GIE (Gastrointestinal Endoscopy) by authors Arvind J. Trindade, MD, Robert D. Odze, MD, FRCPc, Michael S. Smith, MD, MBA and Vivek Kaul, MD, FASGE. Continue Reading "WATS3D has previously shown diagnostic effectiveness for patients with known or suspected BE," said the lead author of the study, Dr. Arvind Trindade, Regional Director of Endoscopy, Northwell Health. "This new study focuses on WATS3D performance in short versus long segment esophageal columnar-lined mucosa." Regardless of segment length, WATS3D is highly effective at increasing the diagnostic yield of intestinal metaplasia and dysplasia. Tweet this The WATS3D AI Platform collects a wide area, disaggregated tissue specimen of the entire thickness of the epithelium being tested. This unique tissue specimen is then subjected to specialized, 3-dimensional AI-powered analysis to identify any abnormal cells for presentation to an expert GI pathologist. Co-author, Dr. Michael S. Smith, Chief of Gastroenterology & Hepatology, Mount Sinai West & Mount Sinai Morningside Hospitals, noted, "This study demonstrated that when added as an adjunct to forceps biopsies, WATS3D is highly effective at increasing the diagnostic yield of intestinal metaplasia and dysplasia for the screening and surveillance of patients with esophageal columnar mucosa regardless of segment length." "The findings highlight the value of WATS3D as a reliable, adjunctive tool for endoscopists looking to enhance the diagnostic yield for detecting intestinal metaplasia and dysplasia in their patients with suspected or known Barrett's in order to pre-empt neoplastic change and improve patient management and outcomes," added senior author Dr. Vivek Kaul, Segal-Watson Professor of Medicine, Division of Gastroenterology & Hepatology, University of Rochester Medical Center. 8471 patients (52.5% male, mean age 53 years) were enrolled from two registry studies. All patients in the study were either being screened or were surveyed for BE by endoscopy with both FB and WATS3D. The adjunctive and absolute yields of WATS3D were calculated according to the length of the patient's BE segment. Intestinal metaplasia and dysplasia detection both increased markedly with the adjunctive use of WATS3D in all segment lengths of Barrett's esophagus, both short and long. (overall adjunctive yields were 128% and 145% respectively for detection of dysplasia). "This study underscores the clinical versatility of WATS3D for the detection of Barrett's and dysplasia," said William Huffnagle, CEO of CDx Diagnostics. "The utility of this powerful technology provides clinicians with the practical advantage they've been looking for to identify and combat preneoplastic esophageal pathology." Dr. Smith, Dr. Kaul, and Dr. Odze are paid consultants with CDx Diagnostics, Inc. None of the consultants received compensation for their work on this study. 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 in time for effective treatment. CDx Diagnostics is a Galen Partners portfolio company. To learn more, visit . Media contact: Logan Garrett 423.519.9979 [email protected] SOURCE CDx Diagnostics