SOURCE: CDx Diagnostics

CDx Diagnostics

May 19, 2013 15:00 ET

New Data Reinforce the Value of the CDx Diagnostics' WATS3D Biopsy in Detecting Otherwise Hidden Precancer of the Esophagus

Multicenter Study Confirms Earlier Research Showing That a Unique "Wide Area Biopsy" Analyzed by 3D Imaging Algorithms Originally Developed for Missile Defense, Can Help to Defend Patients Against Undetected Precancerous Disease

ORLANDO, FL--(Marketwired - May 19, 2013) - CDx Diagnostics announced today that new data from routine clinical use in a number of academic GI centers continue to support use of company's WATS3D (Wide Area Transepithelial Sample biopsy with 3-dimensional analysis) as an additional surveillance tool to increase detection of dysplasia and Barrett's Esophagus. Barrett's Esophagus is a condition that can arise as a result of chronic gastroesophageal reflux disease (GERD) and can be a pre-cursor to esophageal cancer. The data were presented in a poster session at Digestive Disease Week® (DDW®), taking place from May 18-21, 2013.

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

The retrospective, multicenter study (Abstract number Su1452) "Initial Multicenter Experience With Wide Area Transepithelial Esophageal Biopsy With 3D Computer Assisted Analysis for the Detection of Barrett's Esophagus," led by Seth A. Gross, M.D., Assistant Professor of Medicine at the NYU School of Medicine and Director of Endoscopy at Tisch Hospital, NYU Langone Medical Center, found that WATS3D increased detection yield of Barrett's Esophagus by 20% (9-32%, p < .05). Correlation of WATS3D and forceps biopsy results was uniformly high among all sites with an average concordance index of .88 and a range of .82-.94. In three sites that had more than 30 WATS3D 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).1, 2

"These results reinforce findings from previous clinical trials showing that WATS3D biopsy significantly increased the detection rate of Barrett's Esophagus as well as precancerous changes in esophageal tissue in GERD patients," said Seth Gross M.D. "The higher yield rate at sites that had more experience with the technology suggests a modest learning curve."

Esophageal cancer is now the fastest growing form of cancer in the United States. Early detection is particularly difficult because dysplasia in Barrett's Esophagus is often inconspicuous, flat, and patchy in distribution. Studies evaluating patients undergoing esophagectomy for high-grade dysplasia have found adenocarcinoma in 43-57% of patients that was undetected at surveillance endoscopy.3

"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.

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
By combining the power of proprietary computer algorithms with confirmation from expert pathologists, the WATS3D biopsy delivers results that enable healthcare professionals to detect pre-cancerous cells earlier.

The WATS3D biopsy is developed by CDx Diagnostics (www.cdxdiagnostics.com), the world's leader in the prevention of cancer of the oral cavity, pharynx, larynx and esophagus through early detection of their pre-cancerous precursors. Clinicians use the WATS3D biopsy instruments to collect, through minimally invasive procedures, a wide area, disaggregated tissue specimen of the entire thickness of the suspect epithelium. This unique tissue specimen is then subjected to specialized, computer-assisted laboratory analysis. In clinical trials, CDx Diagnostics' WATS3D biopsy significantly increased the detection rate of Barrett's esophagus in GERD patients as well as precancerous changes in esophageal tissue (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.

About Digestive Disease Week
Digestive Disease Week® (DDW®) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 18 - 21, 2013, at the Orange County Convention Center, Orlando, FL. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.

1 Johanson, J. F., J. Frakes, D. Eisen, (2010). Computer-assisted analysis of abrasive transepithelial brush biopsies increases the effectiveness of esophageal screening: a multicenter prospective clinical trial by the endocdx collaborative group. Dig Dis Sci, e-pub

2 Anandasabapathy, Sharmila, Stephen Sontag, David Y. Graham, Stephen Frist, Joan Bratton, Noam Harpaz, Jerome D. Waye. (2010). Computer-assisted brush-biopsy analysis for the detection of dysplasia in a high-risk barrett's esophagus surveillance population. Dig Dis Sci, e-pub

3 Vieth M, Ell C, Gossner L, May A, Stolte M. Histological analysis of endoscopic resection specimens from 326 patients with Barrett's esophagus and early neoplasia. Endoscopy. 2004;36:776-781.

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