Sophisticated Algorithm Helps Detect Barrett's Esophagus

A novel wide area biopsy system collects disaggregated tissue specimens of the entire thickness of suspect epithelium.

The EndoCDx device uses a combination of a minimally invasive biopsy with proprietary tissue analysis technologies and specially trained pathologists to increase the detection of the precursors of oral, laryngeal, and esophageal cancer, via wide area transepithelial-sample biopsy with 3-dimensional (3D) analysis (WATS3D). The device uses “brush biopsy” instruments to collect tissue specimens that are then subjected to a specialized, computer-assisted 3D algorithm to pinpoint potentially abnormal cells for presentation to a pathologist.


Clinically, with the esophagus intubated and the esophageal mucosa clearly visualized, a WATS tip is retracted into its surrounding sheath and the brush passed down the biopsy channel. The tip is then rotated outwards and repeatedly passed back and forth over the abnormality and/or squamocolumnar junction until pinpoint bleeding is observed. Once the sample is collected, the WATS tip is again retracted into the sheath and the brush removed from channel. The cellular material collected is spread onto the bar-coded side of a glass slide, the bristle portion of WATS is clipped off, and the samples are sent for processing and analysis.

The high sensitivity of the test is due to the proprietary computer imaging system that is based on an algorithm developed as part of the "Star Wars" missile defense program. The neural network performs sophisticated tests on every cell on the slide, allowing any sign of potential abnormality to be caught at the earliest possible stage. Approximately 200 of the most suspicious cells are then flagged for the pathologists as a starting point for analysis. The pathologists make the diagnosis, and the result is then delivered to the clinician. The EndoCDx device is a product of CDx Diagnostics (Suffern, NY, USA).

“Our goal in developing WATS3D was to overcome the sampling limitations of current biopsy techniques so that healthcare professionals can detect and prevent cancer before it starts,” said Mark Rutenberg, founder, chairman, and CEO of CDx Diagnostics.

Barrett's esophagus refers to an abnormal change (metaplasia) in the cells of the lower portion of the esophagus, when the normal squamous epithelium lining of the esophagus is replaced by goblet cells, which are usually found lower in the gastrointestinal (GI) tract. The medical significance of Barrett esophagus is its strong association with esophageal adenocarcinoma, a particularly lethal form of cancer.

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