CDx Diagnostics unveiled new data that supports the use of its wide area transepithelial sample (WATS) biopsy with 3D analysis to detect hidden pre-cancer of the esophagus.
The WATS 3D biopsy involves the collection of a wide area, disaggregated tissue specimen of the entire thickness of the suspect epithelium. Due to the large tissue area that is sampled, WATS 3D is able to achieve high sensitivity. The specimen is then analyzed using a computer-assisted 3D analysis—which is based on an algorithm that was developed as part of the U.S. Strategic Defense Initiative missile defense program—to pinpoint potentially abnormal cells for presentation to a pathologist.
Previous clinical trials showed that the WATS 3D biopsy significantly increased the detection rate of Barrett’s Esophagus—a condition that can arise as a result of chronic gastroesophageal reflux disease and can be a pre-cursor to esophageal cancer. But new data, which was presented at Digestive Disease Week held May 18-21, and was derived from a multicenter study, show that the WATS 3D biopsy increased detection yield of Barrett’s Esophagus by 20% (9-32%, p < .05).
In addition, correlation of WATS 3D and forceps biopsy results was uniformly high among all sites with an average of concordance index of .88 and a range of .82-.94. Three sites that had more than 30 WATS 3D tests performed or had on-site assistance, the increased detection yield of Barrett’s Esophagus was an average of 46% (20%-88%, p < .05, n=75), according to the press release.
View the press release on the Wall Street Journal.
View more information on CDx Diagnostics.
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