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Study Shows WATS3D Biopsy Increases Detection of Pre-Cancer in the Esophagus by 50% in Post-Ablation Patients


October 14, 2013 - SAN DIEGO, CA

CDx Diagnostics announced today that a new study adds to the growing body of evidence supporting the use of Wide Area Transepithelial Sampling with 3-Dimensional analysis (WATS3D) as a surveillance tool in patients who have received ablation therapy for Barrett's esophagus. Researchers from Temple University School of Medicine presented the new data at the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course, taking place from October 11-16, 2013 in San Diego.

The WATS3D biopsy collects a wide area, disaggregated tissue specimen of the entire thickness of the epithelium being tested. This unique tissue specimen is then subjected to specialized, computer-assisted 3-dimensional analysis to identify potentially abnormal cells for presentation to a specially trained GI pathologist.

The study (Abstract number P23) "Wide Area Transepithelial Sampling (WATS3D) Improves Detection Of Residual Or Recurrent Intestinal Metaplasia Within The Tubular Esophagus And Squamocolumnar Junction" found that use of WATS3D, in combination with forceps biopsies, increased the detection rate of precancerous tissue by 50%. The authors concluded that WATS3D provides critically important information that improves the management of patients who already underwent therapy to eradicate previously diagnosed Barrett's esophagus. This precancerous condition results from prolonged damage to the esophagus related to reflux of stomach contents.

"In addition to reinforcing previous findings demonstrating the value of using WATS3D as a surveillance tool in patients who have received ablation therapy, this study also provides new information about its utility to detect metaplasia in the tubular esophagus," said Michael S. Smith, M.D., M.B.A., Medical Director of the Esophageal Program and Assistant Professor of Medicine at Temple University School of Medicine. "Research to date has shown that, following ablation of Barrett's esophagus, most residual or recurrent pre-cancerous cells are found at the squamocolumnar junction, where the bottom of the esophagus and the stomach come together. WATS3D not only increased detection of the precancerous cells at this location, but also found them higher in the esophagus where there is a lot of tissue not sampled by conventional forceps biopsies. The ability to better detect these abnormal cells before they have a chance to progress to cancer will help us to improve the care we provide to our Barrett's patients."

In the study, 33 patients with visually eradicated long-segment Barrett's esophagus underwent surveillance endoscopy. Residual or recurrent intestinal metaplasia was detected on either forceps biopsy or WATS3D in 12 cases (36.4%). In 6 of these cases, the intestinal metaplasia only was found using WATS3D and not with forceps biopsies. While in 5 cases the intestinal metaplasia was found at the squamocolumnar junction, in 1 case the intestinal metaplasia was present at least 3 cm proximal to the top of the stomach. In a seventh case, both WATS3D and forceps biopsies identified intestinal metaplasia. However, forceps biopsies found only non-dysplastic metaplasia while WATS3D showed high grade dysplasia, only one step from cancer.

About Barrett's Esophagus and Esophageal Cancer
Many cases of esophageal adenocarcinoma (EA) are preceded by chronic heartburn. Some heartburn patients develop altered cell patches in their esophagus. A condition known as dysplasia occurs as Barrett's esophagus progresses to Barrett's-associated cancer. Dysplasia is considered a precancerous condition and should be monitored very closely to ensure the cells do not become cancerous. Dysplastic cells are very similar to cancer cells but have not yet acquired the ability to invade into tissue or metastasize. Esophageal cancer is now the fastest growing form of cancer in the U.S.

About CDx Diagnostics and the WATS3D Biopsy
CDx Diagnostics' mission is to provide doctors with the most powerful diagnostic technology to help prevent cancer before it can start.

CDx Diagnostics' WATS3D biopsy addresses the sampling error inherent in random forceps biopsy testing of the esophagus. In just a few minutes, gastroenterologists can easily obtain a wide area, full-thickness transepithelial tissue sample for computer-assisted 3D laboratory analysis. In clinical trials, adjunctive use of CDx Diagnostics' WATS3D biopsy significantly increased the detection rate of both Barrett's esophagus and esophageal dysplasia. The high sensitivity of WATS3D is due to the large tissue area sampled, and the proprietary 3-Dimensionial computer imaging system that is based on an algorithm developed as part of the U.S. Strategic Defense Initiative missile defense program. To learn more about WATS3D, visit www.cdxdiagnostics.com.

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Contact:
Chantal Beaudry or Christopher Frates for CDx Diagnostics
cbeaudry@lazarpartners.com
cmfrates@lazarpartners.com
212-867-1762

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