Advancing Precision in Barrett's Esophagus and Dysplasia Diagnoses: WATS3D Study Demonstrates Exceptional Consensus Among Pathologists


Posted December 23, 2024 by CDXDiagnostics

This was a collaborative study among gastrointestinal pathologists who have an interest and expertise in Barrett’s esophagus.
 
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 Pathologist________________________________________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 interobserver 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.
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Last Updated December 23, 2024