Focus of the Report: This Health Technology Assessment focuses on wide-area transepithelial sampling (WATS) biopsy with 3-dimensional (3D) imaging as an adjunct to or replacement for standard forceps biopsy of the esophagus for detection of Barrett’s esophagus (BE) and esophageal dysplasia, with the goal of reducing the risk of progression to esophageal cancer.

Technology Description: WATS3D biopsy (CDx Diagnostics Inc.) is performed during esophageal endoscopy using a stiff brush that is spun and moved up and down and across abnormal tissue to collect small strips and clumps of cells. Biopsy specimens are stained and analyzed at CDx Diagnostics in a process that includes computerized image analysis of all visible cells, which are displayed with highlighting of suspicious features. The WATS3D biopsy procedure, also referred to as WATS, is performed by a gastroenterologist in an outpatient setting during endoscopic examination of the esophagus and is intended as an adjunct to standard 4-quadrant focal biopsies for screening, diagnosis, or surveillance of patients with known or suspected esophageal precancer (e.g., BE) or cancer.

Controversy: WATS3D biopsy is intended to increase detection of BE and esophageal dysplasia with the goal of reducing the risk of progression to esophageal cancer. Several studies have reported increased incremental (i.e., added) diagnostic yield of WATS3D for detection of disease when used as an adjunct to forceps biopsy. However, controversy exists as to whether the incremental benefit is due to (1) better sampling by WATS3D or greater dysplasia detection by the analysis algorithm or (2) false-positive WATS3D findings and thus overdiagnosis of dysplasia. Inaccurate or overdiagnosis of dysplasia has the potential to result in unnecessary esophageal endoscopies and overtreatment of patients. Current guidelines and position statements vary in their recommendations on the role of WATS3D in surveillance of patients with BE.

Key Questions:

  • What is the diagnostic accuracy of WATS3D biopsy for the screening and surveillance of BE and esophageal dysplasia?

  • Does WATS3D biopsy improve patient management or patient outcomes in patients undergoing screening or surveillance for BE and esophageal dysplasia?

  • How does WATS3D biopsy compare with other methods for screening and surveillance of BE and esophageal dysplasia?

  • Is WATS3D biopsy associated with any safety issues?

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