New Data Confirm Value of CDx Diagnostics' WATS3D Biopsy in Detecting Residual Precancerous Tissue Following Ablation for Barrett's Esophagus

LAS VEGAS, NV--(Marketwire - Oct 22, 2012) - CDx Diagnostics announced today that new data support the use of the company's Wide Area Transepithelial Sample (WATS) 3-dimensional biopsy as an additional surveillance tool to confirm that all precancerous tissue was successfully removed following minimally-invasive ablation procedures to treat 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 precursor to esophageal cancer.

The data were announced in a poster session at the American College of Gastroenterology (ACG) Annual Scientific Meeting, taking place in Las Vegas from October 19-24, 2012.

Previously, if patients were suspected of having Barrett's esophagus with dysplasia, they would often consider having their esophagus surgically removed to eliminate the threat of cancer, which could negatively impact their quality of life. Radiofrequency ablation has made it possible for doctors to treat Barrett's esophagus effectively without removing the esophagus. The study highlights the value of using the WATS^3D biopsy to ensure that ablation completely removed all Barrett's tissue.

"In recent years, significant advances in therapeutic and diagnostic tools for Barrett's esophagus have emerged, opening the door for minimally invasive alternatives to esophagectomy. Patients who undergo endoscopic therapy for Barrett's must be monitored to confirm that all precancerous tissue has been eliminated and doesn't return," said Michael S. Smith, MD, MBA, Assistant Professor, Medicine and Medical Director of the Temple Esophageal Program at Temple University School of Medicine. "These new data show that WATS^3D biopsy is a valuable adjunctive technique to improve the quality of our post-ablation surveillance."

Dr. Smith presented results of a study looking at patients who had received either radiofrequency ablation or liquid nitrogen spray cryotherapy for Barrett's esophagus (poster presentation #23, "Wide Area Transepithelial Sampling (WATS-3D) Improves Detection of Barrett's Esophagus Following Endoscopic Ablation"). His results indicate that WATS^3D biopsy increased detection of residual or recurrent pre-cancerous cells by 57.1% compared to using forceps biopsy alone.

"Ablation is a step forward for Barrett's patients, as it is a minimally-invasive treatment for the condition, which can turn cancerous if left untreated," said Mark Rutenberg, founder, chairman, and CEO of CDx Diagnostics. "WATS^3D biopsy closes the loop on the prevention of esophageal cancer, by ensuring that patients who have had ablation have no remaining Barrett's tissue, which could potentially become cancerous later on. Radiofrequency ablation is a remarkable tool, and WATS^3D biopsy is a promising adjunct to ablation in the fight against esophageal precancer."

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.¹

About CDx Diagnostics and the WATS^3D biopsy
The WATS^3D 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 CDx patented WATS^3D 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' WATS^3D biopsy, a patented computer-aided brush biopsy examination, significantly increased the detection rate of Barrett's esophagus in GERD patients as well as precancerous changes in esophageal tissue (dysplasia) by up to 40%^2,3. The high sensitivity of WATS^3D is due to the large tissue area sampled, and the proprietary 3-Dimensional computer imaging system that is based on an algorithm developed as part of the U.S. Strategic Defense Initiative missile defense program.

About ACG
The American College of Gastroenterology is a recognized leader in educating GI professionals and the general public about digestive disorders. Our mission: to serve the evolving needs of physicians in the delivery of high quality scientific, humanistic and cost-effective health care to gastroenterology patients. To learn more about ACG, visit our corporate website at http://gi.org.

¹ http://emedicine.medscape.com/article/277930-overview#a0199

² 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

³ 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