Health Problem: Approximately 20% of the U.S. population is affected by gastroesophageal reflux disease (GERD). Persistent GERD may lead to esophageal damage and may precede other serious conditions, including Barrett’s esophagus, a precancerous condition that can proceed to potentially lethal esophageal adenocarcinoma. Patients who have Barrett’s esophagus need regular endoscopic examinations so that abnormal growth or cancer can be detected and treated at early stages.

Technology Description: Wide-area transepithelial sampling (WATS) biopsy with 3-dimensional imaging (CDx Diagnostics Inc.) is performed as an adjunct to standard forceps biopsy of the esophagus for detection of Barrett’s esophagus and esophageal dysplasia. During WATS biopsy, a brush is passed through the working channel of an endoscope positioned at sites that have signs of abnormality. The brush is spun and moved up and down in a zig-zag pattern across the abnormal area. Biopsy specimens are then submitted to the CDx Diagnostics laboratory for staining and analysis. This process includes computerized image analysis of every cell on every slide. When the computerized image analysis is done, the software displays images of the 200 sites on each slide with the highest likelihood of abnormality. These results and the original slide are reviewed by a pathologist to determine whether Barrett’s esophagus, esophageal dysplasia, or cancer is present.

Controversy: The WATS biopsy brush can be used to sample a large area and obtain some transepithelial segments of esophageal tissue. However, the sample collection process separates surface epithelium from deeper glandular tissue, interfering with the ability to differentiate high-grade dysplasia from early adenocarcinoma. This disruption of tissue architecture by the WATS biopsy brush may lead to inaccurate or overdiagnosis.

Key Questions:

  • What is the diagnostic accuracy of WATS biopsy for the detection of Barrett’s esophagus and esophageal dysplasia?

  • How does the diagnostic accuracy of WATS biopsy compare with other methods of esophageal biopsy?

  • Does WATS biopsy improve patient management or patient outcomes?

  • Is WATS biopsy associated with any safety issues?

  • Have patient selection criteria been established for WATS biopsy?

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